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Clinical Trial Results:
A Phase 3, Randomised, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Maintenance Treatment and Flare Reduction With Crisaborole Ointment, 2%, Once Daily Over 52 Weeks in Pediatric and Adult Subjects (Ages 3 Months and Older) with Mild-to-Moderate Atopic Dermatitis, who Responded to Twice Daily Crisaborole Ointment, 2%, Treatment

Summary
EudraCT number	2019-000443-28
Trial protocol	AT ES FR
Global end of trial date	19 Jan 2022

Results information
Results version number	v1(current)
This version publication date	16 Jul 2022
First version publication date	16 Jul 2022
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

C3291035

ISRCTN number

US NCT number

NCT04040192

WHO universal trial number (UTN)

Sponsor organisation name

Pfizer Inc.

Sponsor organisation address

235 E 42nd Street, New York, United States, NY 10017

Public contact

Pfizer Inc., Pfizer ClinicalTrials.gov Call Center, 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com

Scientific contact

Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

20 Apr 2022

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

19 Jan 2022

Was the trial ended prematurely?

Main objective of the trial

To evaluate the long-term efficacy of crisaborole ointment, 2%, once daily (QD) for maintenance therapy and flare reduction in paediatric and adult subjects >=3 months of age with mild-to-moderate atopic dermatitis (AD) who responded to crisaborole ointment, 2%, twice daily (BID) treatment. To evaluate the safety and local tolerability of crisaborole ointment, 2%, QD for maintenance therapy and flare reduction in paediatric and adult subjects >=3 months of age with mild-to-moderate AD.

Protection of trial subjects

The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trials subjects were followed.

Background therapy

Evidence for comparator

Actual start date of recruitment

12 Sep 2019

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Australia: 30

Country: Number of subjects enrolled

Canada: 19

Country: Number of subjects enrolled

China: 59

Country: Number of subjects enrolled

Israel: 9

Country: Number of subjects enrolled

Turkey: 8

Country: Number of subjects enrolled

United States: 372

Worldwide total number of subjects

497

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

202

Adolescents (12-17 years)

105

Adults (18-64 years)

155

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

A total of 620 subjects signed the informed consent form. 78 subjects were screen failures who did not meet eligibility criteria and were not enrolled. 542 subjects were enrolled, out of which only 497 were assigned to study treatment.

Period 1 title

Open Label Period (up to 8 weeks)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Crisaborole 2% BID

Arm description

Subjects with mild to moderate AD were administered Crisaborole 2% ointment applied topically BID for maximum duration of up to 8 weeks in open label (OL) Run-in period.

Arm type

Experimental

Investigational medicinal product name

Crisaborole

Investigational medicinal product code

Other name

Pharmaceutical forms

Ointment

Routes of administration

Topical use

Dosage and administration details

2% (20 milligrams/gram) crisaborole ointment, applied topically twice daily.

Number of subjects in period 1	Crisaborole 2% BID
Started	497
Completed	270
Not completed	227
Physician decision	3
Consent withdrawn by subject	8
Failure to meet randomisation criteria	152
Adverse event	18
Unspecified	11
Lost to follow-up	14
Withdrawal by parent/guardian	18
Protocol deviation	3

Period 2 title

Double blind Period (up to 52 weeks)

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Vehicle QD

Arm description

Subjects identified as responders during the OL period were randomised to receive vehicle applied topically QD for 52 weeks in the double-blind (DB) maintenance period. Subjects who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.

Arm type

Placebo

Investigational medicinal product name

Crisaborole Vehicle

Investigational medicinal product code

Other name

Pharmaceutical forms

Ointment

Routes of administration

Topical use

Dosage and administration details

Applied topically, once daily

Crisaborole 2% QD

Arm description

Subjects identified as responders during the OL period were randomised to receive Crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. Subjects who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with crisaborole 2% QD.

Arm type

Experimental

Investigational medicinal product name

Crisaborole

Investigational medicinal product code

Other name

Pharmaceutical forms

Ointment

Routes of administration

Topical use

Dosage and administration details

2% (20 mg/g) crisaborole ointment, applied topically once daily

Number of subjects in period 2	Vehicle QD	Crisaborole 2% QD
Started	135	135
Completed	78	78
Not completed	57	57
Consent withdrawn by subject	6	11
Physician decision	-	2
Pregnancy	2	-
Adverse event	3	1
Unspecified	29	18
Lost to follow-up	6	10
Missing	2	5
Withdrawal by parent/guardian	8	7
Protocol deviation	1	3

Baseline characteristics

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Reporting group title

Crisaborole 2% BID

Reporting group description

Subjects with mild to moderate AD were administered Crisaborole 2% ointment applied topically BID for maximum duration of up to 8 weeks in open label (OL) Run-in period.

Reporting group values	Crisaborole 2% BID	Total
Number of subjects	497	497
Age Categorical
Units: Subjects
In utero	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0
Newborns (0-27 days)	0	0
Infants and toddlers (28 days-23 months)	20	20
Children (2-11 years)	202	202
Adolescents (12-17 years)	105	105
Adults (18-64 years)	155	155
From 65-84 years	15	15
85 years and over	0	0
Age Continuous
Units: years
arithmetic mean (standard deviation)	19.89 ± 18.443	-
Gender Categorical
Units: Subjects
Female	283	283
Male	214	214
Race
Units: Subjects
White	204	204
Black or African American	161	161
Asian	101	101
American Indian or Alaska Native	2	2
Native Hawaiian or Other Pacific Islander	1	1
Multiracial	18	18
Not reported	10	10
Ethnicity
Units: Subjects
Hispanic or Latino	54	54
Not Hispanic or Latino	426	426
Not reported	17	17

End points

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Reporting group title

Crisaborole 2% BID

Reporting group description

Subjects with mild to moderate AD were administered Crisaborole 2% ointment applied topically BID for maximum duration of up to 8 weeks in open label (OL) Run-in period.

Reporting group title

Vehicle QD

Reporting group description

Reporting group title

Crisaborole 2% QD

Reporting group description

Primary: Duration of Flare-Free Maintenance Until Onset of First-Flare During the Double Blind (DB) Period

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End point title

Duration of Flare-Free Maintenance Until Onset of First-Flare During the Double Blind (DB) Period

End point description

The duration of flare-free maintenance is the time from randomization to the last Investigator’s Static Global Assessment (ISGA) assessment and is right censored, if an intercurrent event (eg, death, dropout, loss to follow up, or end of study) occurs before the first flare. When a flare occurs first, the duration of flare free maintenance is the time from randomization to the first flare and is not censored. Duration of flare free maintenance was estimated using the Kaplan-Meier method. Evaluable-DB (Eval-DB) population included all randomised subjects with success in ISGA and Eczema Area Severity Index score (EASI50) criteria as responders at randomisation and received at least 1 dose of study intervention in the DB period.

End point type

Primary

End point timeframe

From randomisation to first flare or last ISGA assessment (up to 52 weeks)

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	129	125
Units: Days
median (confidence interval 95%)	30 (28 to 56)	111 (56 to 224)

Crisaborole 2% QD vs Vehicle QD

Comparison groups

Vehicle QD v Crisaborole 2% QD

Number of subjects included in analysis

254

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.0034 ^[1]

Method

Logrank

Confidence interval

Notes
[1] - p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomisation.

Primary: Number of Subjects With Treatment Emergent Adverse Events (TEAEs)

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End point title

Number of Subjects With Treatment Emergent Adverse Events (TEAEs) ^[2]

End point description

An adverse event (AE) was any untoward medical occurrence in a clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started on or after the treatment period start date and before end of study (at least 28 days after last dose of study intervention). Safety population comprised of all subjects who received at least 1 dose of study intervention during the study.

End point type

Primary

End point timeframe

From start of study intervention up to 8 weeks (Crisaborole 2% BID arm); From start of study intervention in DB period up to 28 days after last dose of study intervention (maximum of 56 weeks) (for vehicle QD and crisaborole 2% QD)

Notes
[2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This is a safety endpoint, and no statistical testing was conducted on any safety endpoints.

End point values	Crisaborole 2% BID	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	497	135	135
Units: Subjects	109	49	36

No statistical analyses for this end point

Secondary: Number of Flare-Free Days During the DB Period

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End point title

Number of Flare-Free Days During the DB Period

End point description

Flare - free days was the sum of the duration of flare-free maintenance of all QD periods during the maintenance period for each subject. Eval-DB population included all randomised subjects with success in ISGA and EASI50 criteria as responders at randomisation and received at least 1 dose of study intervention in the DB period.

End point type

Secondary

End point timeframe

Up to maximum of 52 weeks

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	129	125
Units: Days
least squares mean (standard error)	199.42 ± 11.824	234.01 ± 12.323

Crisaborole 2% QD vs Vehicle QD

Comparison groups

Vehicle QD v Crisaborole 2% QD

Number of subjects included in analysis

254

Analysis specification

Pre-specified

Analysis type

other ^[3]

P-value

= 0.0346

Method

ANCOVA

Parameter type

Least square mean difference

Point estimate

34.59

Confidence interval

level

95%

sides

2-sided

lower limit

2.53

upper limit

66.64

Variability estimate

Standard error of the mean

Dispersion value

16.274

Notes
[3] - Analysis of covariance (ANCOVA) model included fixed effects of treatment group, age group, duration of the BID treatment in OL period, and ISGA score at randomisation.

Secondary: Number of Flares During the DB Period

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End point title

Number of Flares During the DB Period

End point description

Flare was defined as an ISGA score of >=2. The ISGA is a 5-point scale (0-4), reflecting a global assessment of AD severity based on erythema, induration/papulation, and oozing/crusting. ISGA score of 2: mild (faint pink erythema with mild induration/papulation and no oozing/crusting) 3: moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting) and 4: severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Eval-DB population included all randomised subjects with success in ISGA and EASI50 criteria as responders at randomisation and received at least 1 dose of study intervention in the DB period.

End point type

Secondary

End point timeframe

Up to maximum of 52 weeks

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	129	125
Units: Flares
median (full range (min-max))	1.00 (0.6 to 99999)	1.00 (0.4 to 99999)

Crisaborole 2% QD vs Vehicle QD

Comparison groups

Vehicle QD v Crisaborole 2% QD

Number of subjects included in analysis

254

Analysis specification

Pre-specified

Analysis type

other ^[4]

P-value

= 0.0042 ^[5]

Method

Wilcoxon (Mann-Whitney)

Parameter type

Median difference (final values)

Point estimate

-0.5

Confidence interval

level

95%

sides

2-sided

lower limit

-1

upper limit

Notes
[4] - Median difference and 95%CI were estimated using Hodges-Lehmann method.
[5] - p-value was estimated by Wilcoxon rank sum test stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomisation.

Secondary: Duration of Pruritus Response Maintenance Until Onset of First Flare During the DB Period

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End point title

Duration of Pruritus Response Maintenance Until Onset of First Flare During the DB Period

End point description

Duration of maintenance of pruritus response was time from randomisation to loss of pruritus response or first flare onset (ISGA >=2) during 52-week DB period for subjects who were pruritus responders at randomisation. Pruritus(p) response maintenance was defined as maintenance of >=50% improvement in pruritus from baseline that was obtained at randomisation. If an event (e.g., death, first flare [ISGA >=2], lost to follow up, or end of study) occurred before loss of pruritus response for first flare-free period,duration of maintenance of pruritus response was time from randomisation to the last assessment and was censored. Eval-DB population was analysed. 99999: data not available. Here, 'number of subjects analysed (N): evaluable for this end point,‘n’: number of subjects evaluable for specified rows.

End point type

Secondary

End point timeframe

From randomisation up to loss of pruritus response or onset of first flare or the last assessment (maximum of 52 weeks)

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	85	81
Units: Days
median (confidence interval 95%)
≥12yrs:Baseline Peak p NRS≥3,≥3 pt reduced;n=25,37	99999 (18 to 99999)	164 (105 to 99999)
≥12yrs:Baseline Peak p NRS≥4,≥4 pt reduced;n=18,24	99999 (16 to 99999)	309 (141 to 99999)
6-<12yrs:Baseline PRIS Scale≥2,≥2pt reduced;n=10,2	99999 (2 to 99999)	133 (28 to 238)
3mon-<6yrs:BaselineORISScale≥3,≥3pt reduce;n=20,10	7 (4 to 99999)	99999 (2 to 99999)
3mon-<6yrs:BaselineORISScale≥4,≥4pt reduce;n=12,8	8 (4 to 99999)	99999 (2 to 99999)

Crisaborole 2% QD vs Vehicle QD

Comparison groups

Vehicle QD v Crisaborole 2% QD

Number of subjects included in analysis

166

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.1518 ^[6]

Method

Logrank

Confidence interval

Notes
[6] - p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomisation.

Crisaborole 2% QD vs Vehicle QD

Comparison groups

Vehicle QD v Crisaborole 2% QD

Number of subjects included in analysis

166

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.6815 ^[7]

Method

Logrank

Confidence interval

Notes
[7] - p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomisation.

Crisaborole 2% QD vs Vehicle QD

Comparison groups

Vehicle QD v Crisaborole 2% QD

Number of subjects included in analysis

166

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.3778 ^[8]

Method

Logrank

Confidence interval

Notes
[8] - p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomisation.

Crisaborole 2% QD vs Vehicle QD

Comparison groups

Vehicle QD v Crisaborole 2% QD

Number of subjects included in analysis

166

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.487 ^[9]

Method

Logrank

Confidence interval

Notes
[9] - p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomisation.

Crisaborole 2% QD vs Vehicle QD

Comparison groups

Vehicle QD v Crisaborole 2% QD

Number of subjects included in analysis

166

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.1933 ^[10]

Method

Logrank

Confidence interval

Notes
[10] - p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomisation.

Secondary: Duration of Maintenance of Greater Than or Equal to (>=) 50% Reduction in Eczema Area and Severity Index (EASI) Total Score Until Onset of First Flare During the DB Period

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End point title

Duration of Maintenance of Greater Than or Equal to (>=) 50% Reduction in Eczema Area and Severity Index (EASI) Total Score Until Onset of First Flare During the DB Period

End point description

EASI:severity of AD based on severity of lesion clinical signs and%body surface area(BSA)affected.Severity of clinical signs of AD lesions(erythema (E),induration/papulation(I),excoriation(Ex),lichenification(L)):scored separately for each of 4 body regions(head and neck[h],upper limbs[u],trunk[t][including axillae and groin)],lower limbs[l][including buttocks])on4-point scale:0=absent;1=mild;2=moderate;3=severe.EASI area score:%BSA withAD:0 (0%),1(>0 to <10%),2(10 to <30%),3(30 to <50%),4(50 to <70%),5(70 to <90%),6(90 to 100%).Total score =0.1*Ah*(Eh+Ih+Exh+Lh)+0.2*Au*(Eu+Iu+ExU+Lu)+0.3*At*(Et+It+Ext+Lt)+0.4*Al*(El+Il+Exl+Ll);A=EASI area score.For age<8 years old:Total score=0.2*Ah*(Eh+Ih+Exh+Lh)+0.2*Au*(Eu+Iu+ExU+Lu)+0.3*At*(Et+It+Ext+Lt)+ 0.3*Al*(El+Il+Exl+Ll).Total score:0.0to72.0,higher score:greater severity of AD.EASI response maintenance:score that does not lose more than50%of achieved reduction from Day1/Baseline run-in EASI score.Eval-DB analysed.99999:data not available.

End point type

Secondary

End point timeframe

From randomisation to loss of EASI response or the last EASI assessment (up to maximum of 52 weeks)

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	129	125
Units: Days
median (confidence interval 95%)	198 (84 to 99999)	99999 (175 to 99999)

Crisaborole 2% QD vs Vehicle QD

Comparison groups

Vehicle QD v Crisaborole 2% QD

Number of subjects included in analysis

254

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.1159 ^[11]

Method

Logrank

Confidence interval

Notes
[11] - p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomisation.

Secondary: Duration of Maintenance of Dermatology Life Quality Index (DLQI) Response Until Onset of First Flare During the DB Period

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End point title

Duration of Maintenance of Dermatology Life Quality Index (DLQI) Response Until Onset of First Flare During the DB Period

End point description

DLQI is a 10-item questionnaire that measured the impact of skin disease. Each question was evaluated on a 4-point scale (range 0 to 3) where, 0 = not at all, 1= a little, 2= a lot, 3= very much, where higher scores indicated more impact on quality of life. Scores from all 10 questions were added up to give DLQI total score, ranging from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of subjects. DLQI response maintenance was defined as the response that does not lose more than minimal clinical important difference. 99999: data not available. Eval-DB population included all randomised subjects with success in ISGA and EASI50 criteria as responders at randomisation and received at least 1 dose of study intervention in the DB period. Here, ‘N’ signifies subjects evaluable for this endpoint and ‘n’ signifies subjects evaluable at specific rows.

End point type

Secondary

End point timeframe

From randomisation to loss of DLQI response or the last assessment up to first flare (up to maximum of 52 weeks)

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	86	82
Units: Days
median (confidence interval 95%)
DLQI for subjects >=16 years of age (n=40, 41)	99999 (111 to 99999)	99999 (187 to 99999)
Children’s DLQI:subjects4-<16 yrs of age(n=46,41)	99999 (360 to 99999)	99999 (271 to 99999)

Crisaborole 2% QD vs Vehicle QD

Comparison groups

Vehicle QD v Crisaborole 2% QD

Number of subjects included in analysis

168

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.7456 ^[12]

Method

Logrank

Confidence interval

Notes
[12] - p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomisation.

Crisaborole 2% QD vs Vehicle QD

Comparison groups

Vehicle QD v Crisaborole 2% QD

Number of subjects included in analysis

168

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.6973 ^[13]

Method

Logrank

Confidence interval

Notes
[13] - p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomisation.

Secondary: Duration of Maintenance of Patient Oriented Eczema Measure (POEM) Response Until Onset of First Flare During the DB Period

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End point title

Duration of Maintenance of Patient Oriented Eczema Measure (POEM) Response Until Onset of First Flare During the DB Period

End point description

POEM was a 7-item subject reported outcome measure used to assess the impact of AD (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) over the past week. Each item was scored as: no days=0, 1-2 days=1, 3-4 days=2, 5-6 days=3 and every day=4. The total score ranged from 0 to 28, where higher score indicated greater severity. POEM response maintenance was defined as the response that does not lose more than minimal clinical important difference. Eval-DB population included all randomised subjects with success in ISGA and EASI50 criteria as responders at randomisation and received at least 1 dose of study intervention in the DB period. 99999: data not available. Here, 'N': subjects evaluable for this end point and 'number of subjects analysed': number of subjects evaluable for specified rows.

End point type

Secondary

End point timeframe

From randomisation to loss POEM response or the last assessment up to the first flare (up to maximum of 52 weeks)

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	54	64
Units: Days
median (confidence interval 95%)
POEM (n=31, 39)	55 (25 to 222)	180 (69 to 322)
Proxy POEM (n=23, 25)	20 (13 to 124)	150 (33 to 99999)

Crisaborole 2% QD vs Vehicle QD

Comparison groups

Vehicle QD v Crisaborole 2% QD

Number of subjects included in analysis

118

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.0217 ^[14]

Method

Logrank

Confidence interval

Notes
[14] - p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomisation.

Crisaborole 2% QD vs Vehicle QD

Comparison groups

Vehicle QD v Crisaborole 2% QD

Number of subjects included in analysis

118

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.0513 ^[15]

Method

Logrank

Confidence interval

Notes
[15] - p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomisation.

Secondary: Investigator's Static Global Assessment (ISGA) Score for the First Flare Period

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End point title

Investigator's Static Global Assessment (ISGA) Score for the First Flare Period

End point description

ISGA:5- point global assessment scale of AD severity, used to characterize overall disease severity across all treatable AD lesions (excluding the scalp). Score ranged from 0 to 4: where 0= clear(minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores: greater severity of AD. Eval-DB population was analysed. Here, ‘N’: number of subjects evaluable for this end point and “n”: number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Week 0 (Day 1), Week 4, Week 8 and Week 12

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	96	81
Units: Units on a scale
arithmetic mean (standard deviation)
Week 0 (n=96, 81)	2.4 ± 0.51	2.3 ± 0.47
Week 4 (n=53, 47)	2.2 ± 0.45	2.2 ± 0.41
Week 8 (n=33,27)	2.1 ± 0.33	2.4 ± 0.57
Week 12 (n=10, 11)	2.3 ± 0.48	2.5 ± 0.52

No statistical analyses for this end point

Secondary: EASI Score for the First Flare Period

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End point title

EASI Score for the First Flare Period

End point description

EASI:severity of subject’s AD based on severity of lesion clinical signs and %BSA affected. Severity of clinical signs of AD lesions(erythema,induration/papulation, excoriation,lichenification)scored separately for each of 4 body regions(head and neck, upper limbs, trunk[including axillae and groin)],lower limbs[including buttocks])on 4-point scale: 0=absent;1=mild;2=moderate;3=severe.EASI area score:%BSA with AD in body region:0(0%), 1(>0 to <10%), 2(10to<30%), 3(30to<50%), 4(50to<70%), 5(70to<90%),6(90to100%).Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh)+0.2*Au*(Eu+Iu+ExU+Lu)+0.3*At*(Et+It+Ext+Lt)+0.4*Al*(El+Il+Exl+Ll);A=EASI area score; E=erythema;I =induration/papulation; Ex =excoriation; L=lichenification; h=head and neck; u=upper limbs;t=trunk;l= lower limbs.Total EASI score range:0.0 to 72.0,higher scores=greater severity of AD. Eval-DB population analysed. Here,'N':number of subjects evaluable for the end point, 'n': number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Week 0 (Day 1), Week 4, Week 8 and Week 12

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	96	81
Units: Units on a scale
arithmetic mean (standard deviation)
Week 0 (n=96, 81)	6.53 ± 5.897	5.27 ± 3.933
Week 4 (n=54, 47)	6.09 ± 5.471	5.02 ± 3.869
Week 8 (n=33, 27)	4.84 ± 5.322	5.66 ± 4.459
Week 12 (n=10,11)	6.25 ± 4.546	6.56 ± 5.647

No statistical analyses for this end point

Secondary: Duration (Days) of Flare Period

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End point title

Duration (Days) of Flare Period

End point description

Duration of flare period was average duration calculated from sum of durations/number of flares for each subject. Eval-DB population included all randomised subjects with success in ISGA and EASI50 criteria as responders at randomisation and received at least 1 dose of study intervention in the DB period. Here, ‘Number of subjects analysed’: number of subjects evaluable for this end point.

End point type

Secondary

End point timeframe

Up to 52 weeks

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	96	81
Units: Days
arithmetic mean (standard deviation)	54.2 ± 28.77	55.3 ± 35.73

No statistical analyses for this end point

Secondary: Percent Change From Baseline in EASI Scores: OL Run-in Period

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End point title

Percent Change From Baseline in EASI Scores: OL Run-in Period

End point description

EASI:severity of subject’s AD based on severity of lesion clinical signs and %BSA affected. Severity of clinical signs of AD lesions(erythema,induration/papulation, excoriation,lichenification)scored separately for each of 4 body regions(head and neck, upper limbs, trunk[including axillae and groin)],lower limbs[including buttocks])on 4-point scale: 0=absent;1=mild;2=moderate;3=severe.EASI area score:%BSA with AD in body region:0(0%), 1(>0 to <10%), 2(10to<30%), 3(30to<50%), 4(50to<70%), 5(70to<90%),6(90to100%).Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh)+0.2*Au*(Eu+Iu+ExU+Lu)+0.3*At*(Et+It+Ext+Lt)+0.4*Al*(El+Il+Exl+Ll);A=EASI area score; E=erythema;I =induration/papulation; Ex =excoriation; L=lichenification; h=head and neck; u=upper limbs;t=trunk;l= lower limbs.Total EASI score range:0.0 to 72.0,higher scores=greater severity of AD. Evaluable-OL (Eval-OL) population included all subjects that received at least 1 dose of study intervention in the OL period.

End point type

Secondary

End point timeframe

Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8

End point values	Crisaborole 2% BID
Number of subjects analysed	497
Units: Percent change
arithmetic mean (standard deviation)
Percent change at Week 2	-31.44 ± 37.151
Percent change at Week 4	-38.52 ± 44.448
Percent change at Week 6	-45.35 ± 49.453
Percent change at Week 8	-52.86 ± 51.209

No statistical analyses for this end point

Secondary: Percent Change From Baseline in EASI Scores: DB Period

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End point title

Percent Change From Baseline in EASI Scores: DB Period

End point description

End point type

Secondary

End point timeframe

Baseline (last observation up to and including the randomisation day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 and 52

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	53	57
Units: Percent change
arithmetic mean (standard deviation)
Percent change at Week 4 (n=38, 57)	2.87 ± 72.981	-10.16 ± 61.161
Percent change at Week 8 (n=42, 53)	1.04 ± 95.062	34.26 ± 224.615
Percent change at Week 12 (n=44, 50)	-0.11 ± 126.465	-8.22 ± 93.118
Percent change at Week 16 (n=53, 57)	26.30 ± 156.188	27.98 ± 282.035
Percent change at Week 20 (n=8, 6)	26.38 ± 147.113	-45.44 ± 54.768
Percent change at Week 24 (n=46, 50)	-20.62 ± 78.665	6.94 ± 162.911
Percent change at Week 28 (n=9, 5)	19.17 ± 112.841	-33.04 ± 31.617
Percent change at Week 32 (n=44, 45)	13.57 ± 131.633	-19.33 ± 81.663
Percent change at Week 36 (n=3, 4)	-55.95 ± 51.052	211.13 ± 155.547
Percent change at Week 40 (n=40, 40)	10.00 ± 142.168	-12.94 ± 148.586
Percent change at Week 44 (n=10, 3)	-59.74 ± 34.119	127.56 ± 322.953
Percent change at Week 48 (n=38, 39)	-22.23 ± 87.761	-30.01 ± 72.497
Percent change at Week 52 (n= 42, 38)	-39.27 ± 72.619	-49.81 ± 56.391

No statistical analyses for this end point

Secondary: Percent Change From Baseline in EASI Scores: First Flare Treatment Period

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End point title

Percent Change From Baseline in EASI Scores: First Flare Treatment Period

End point description

End point type

Secondary

End point timeframe

Weeks 0, 4, 8 and 12

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	73	57
Units: Percent change
arithmetic mean (standard deviation)
Percent change at Week 0 (n=73, 57)	484.69 ± 672.923	324.54 ± 484.380
Percent change at Week 4 (n=48, 35)	294.83 ± 350.182	293.63 ± 461.044
Percent change at Week 8 (n=32, 22)	245.70 ± 411.541	275.66 ± 447.181
Percent change at Week 12 (n=10, 11)	196.69 ± 272.911	408.94 ± 665.204

No statistical analyses for this end point

Secondary: Percent Change From Baseline in EASI Scores: First Flare Free Period

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End point title

Percent Change From Baseline in EASI Scores: First Flare Free Period

End point description

End point type

Secondary

End point timeframe

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	35	56
Units: Percent change
arithmetic mean (standard deviation)
Percent change at Week 4 (n=35, 56)	-0.46 ± 67.355	-10.34 ± 61.699
Percent change at Week 8 (n=26, 48)	-21.34 ± 59.257	10.36 ± 144.770
Percent change at Week 12 (n=24, 42)	2.24 ± 143.094	-9.44 ± 100.314
Percent change at Week 16 (n=19, 37)	-14.82 ± 50.412	-0.47 ± 109.386
Percent change at Week 20 (n=1, 4)	200.00 ± 99999	-74.29 ± 40.808
Percent change at Week 24 (n=16, 32)	-35.57 ± 55.674	-10.82 ± 109.364
Percent change at Week 28 (n=1, 2)	0.00 ± 99999	-34.52 ± 48.824
Percent change at Week 32 (n=15, 26)	-28.39 ± 62.657	-27.82 ± 94.806
Percent change at Week 36 (n=1, 0)	-67.86 ± 99999	99999 ± 99999
Percent change at Week 40 (n=14, 22)	2.19 ± 83.621	-47.60 ± 64.625
Percent change at Week 44 (n=1, 0)	-36.84 ± 99999	99999 ± 99999
Percent change at Week 48 (n=14, 20)	-27.27 ± 61.689	-39.13 ± 82.669
Percent change at Week 52 (n=12, 18)	-54.33 ± 45.072	-59.87 ± 58.964

No statistical analyses for this end point

Secondary: Change From Baseline in ISGA Scores for OL run-in Period

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End point title

Change From Baseline in ISGA Scores for OL run-in Period

End point description

ISGA is a 5- point global assessment scale, used to characterize overall disease severity across all treatable AD lesions (excluding the scalp). Score ranged from 0 to 4: where 0= clear(minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores: greater severity of AD. Eval-OL population included all subjects that received at least 1 dose of study intervention in the OL period.

End point type

Secondary

End point timeframe

Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8

End point values	Crisaborole 2% BID
Number of subjects analysed	497
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline	2.7 ± 0.48
Change at Week 2	-0.5 ± 0.69
Change at Week 4	-0.7 ± 0.84
Change at Week 6	-0.9 ± 0.93
Change at Week 8	-1.2 ± 1.04

No statistical analyses for this end point

Secondary: Change From Baseline in ISGA Scores for DB Period

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End point title

Change From Baseline in ISGA Scores for DB Period

End point description

ISGA is a 5- point global assessment scale, used to characterize overall disease severity across all treatable AD lesions (excluding the scalp). Score ranged from 0 to 4: where 0= clear(minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores: greater severity of AD. Eval-DB population was analysed. Here, 'n’ signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline (last observation up to and including the randomisation day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	129	125
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n=129, 125)	0.6 ± 0.50	0.6 ± 0.49
Change at Week 4 (n=60, 81)	0.2 ± 0.52	0.1 ± 0.49
Change at Week 8 (n=71, 80)	0.2 ± 0.50	0.1 ± 0.58
Change at Week 12 (n=65, 76)	0.1 ± 0.52	0.0 ± 0.54
Change at Week 16 (n=75, 83)	0.2 ± 0.46	-0.0 ± 0.53
Change at Week 20 (n=13, 13)	0.3 ± 0.75	0.2 ± 0.69
Change at Week 24 (n=70, 78)	0.0 ± 0.67	-0.1 ± 0.56
Change at Week 28 (n=12, 6)	0.3 ± 0.45	0.2 ± 0.41
Change at Week 32 (n=62, 72)	-0.0 ± 0.60	-0.1 ± 0.53
Change at Week 36 (n=8, 5)	0.4 ± 0.74	0.0 ± 0.00
Change at Week 40 (n=59, 64)	0.0 ± 0.57	0.0 ± 0.59
Change at Week 44 (n=13, 8)	-0.1 ± 0.64	0.3 ± 0.71
Change at Week 48 (n=58, 64)	0.1 ± 0.65	-0.0 ± 0.63
Change at Week 52 (n=63, 63)	0.0 ± 0.66	-0.0 ± 0.57

No statistical analyses for this end point

Secondary: Change From Baseline in ISGA Scores for First Flare Free Period

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End point title

Change From Baseline in ISGA Scores for First Flare Free Period

End point description

ISGA is a 5- point global assessment scale, used to characterize overall disease severity across all treatable AD lesions (excluding the scalp). Score ranged from 0 to 4: where 0= clear(minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores: greater severity of AD. Eval-DB population was analysed. 99999: data not available. Here, 'n’ signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline (last observation up to and including the randomisation day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	129	125
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n=129, 125)	0.6 ± 0.50	0.6 ± 0.49
Change at Week 4 (n=55, 80)	0.2 ± 0.54	0.1 ± 0.49
Change at Week 8 (n=43, 67)	0.2 ± 0.50	0.1 ± 0.60
Change at Week 12 (n=37, 59)	0.1 ± 0.55	-0.1 ± 0.54
Change at Week 16 (n=31, 52)	0.2 ± 0.43	0.0 ± 0.52
Change at Week 20 (n=1, 5)	0.0 ± 99999	-0.4 ± 0.55
Change at Week 24 (n=26, 46)	0.0 ± 0.63	-0.1 ± 0.55
Change at Week 28 (n=2, 2)	0.5 ± 0.71	0.0 ± 0.00
Change at Week 32 (n=25, 39)	-0.1 ± 0.64	-0.1 ± 0.53
Change at Week 36 (n=1, 1)	0.0 ± 99999	0.0 ± 99999
Change at Week 40 (n=23, 33)	0.0 ± 0.60	-0.1 ± 0.66
Change at Week 44 (n=2, 3)	0.0 ± 0.00	0.7 ± 0.58
Change at Week 48 (n=24, 32)	0.0 ± 0.66	-0.1 ± 0.64
Change at Week 52 (n=22, 30)	0.0 ± 0.62	-0.0 ± 0.61

No statistical analyses for this end point

Secondary: Change From Baseline in ISGA Scores for First Flare Treatment Period

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End point title

Change From Baseline in ISGA Scores for First Flare Treatment Period

End point description

ISGA:5-point global assessment scale, used to characterize overall disease severity across all treatable AD lesions (excluding scalp). Score ranged:0 to 4,where 0=clear(minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1=almost clear(trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2=mild(faint pink erythema with mild induration/papulation and no oozing/crusting), 3=moderate(pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4=severe(deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores:greater severity of AD. Flare treatment period:period between initiation of OL crisaborole2% ointment BID for treatment of flare developed during DB maintenance until resumption of DB treatment.Eval-DB population analysed. Here, ‘N’:subjects evaluable for this endpoint and ‘n’:subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline (last observation up to and including the randomisation day), Weeks 0, 4, 8 and 12

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	96	81
Units: Units on a scale
arithmetic mean (standard deviation)
Week 0 (n=96, 81)	1.8 ± 0.57	1.7 ± 0.49
Change at Week 4 (n=53, 47)	1.5 ± 0.54	1.5 ± 0.55
Change at Week 8 (n=33, 27)	1.3 ± 0.47	1.6 ± 0.74
Change at Week 12 (n=10, 11)	1.5 ± 0.53	1.6 ± 0.67

No statistical analyses for this end point

Secondary: Change from Baseline in Treatable Percent Body Surface Area (% BSA): OL Run-in Period

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End point title

Change from Baseline in Treatable Percent Body Surface Area (% BSA): OL Run-in Period

End point description

The extent (%) to which a body region was involved with AD was determined using handprint method. Four body regions evaluated: head and neck (hn), upper limbs (ul), trunk (tr) (including axillae) and lower limbs (ll) (including buttocks). Total number of handprints=10 for hn, 20 for ul, 30 for tr, 40 for ll in subjects aged >=8 years; 20 for hn, 20 for ul, 30 for tr, 30 for ll in subjects aged 3 months to 7 years. Surface area of body region equivalent to 1 handprint: 10% for hn, 5% for ul, 3.33% for tr, 2.5% for ll in subjects aged >=8 years; 5% for hn, 5% for ul, 3.33% for tr, 3.33% for ll in subjects aged 3 months to 7 years. % BSA for a body region= total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual=sum of % BSA across all 4 body regions and ranged from 0 to 100%, with higher values representing greater extent of BSA involvement with AD. Eval-OL population was analysed.

End point type

Secondary

End point timeframe

Baseline (last observation up to and including the randomisation day) Weeks 2, 4, 6 and 8

End point values	Crisaborole 2% BID
Number of subjects analysed	497
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline	19.61 ± 16.807
Change at Week 2	-3.86 ± 8.313
Change at Week 4	-5.09 ± 10.061
Change at Week 6	-6.42 ± 11.398
Change at Week 8	-7.35 ± 12.301

No statistical analyses for this end point

Secondary: Change from Baseline in Treatable %BSA: DB Period

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End point title

Change from Baseline in Treatable %BSA: DB Period

End point description

The extent (%) to which a body region was involved with AD was determined using handprint method. Four body regions evaluated: hn, ul, tr (including axillae) and ll (including buttocks). Total number of handprints=10 for hn, 20 for ul, 30 for tr, 40 for ll in subjects aged>=8 years; 20 for hn, 20 for ul, 30 for tr, 30 for ll in subjects aged 3 months to 7 years. Surface area of body region equivalent to 1 handprint: 10% for hn, 5% for ul, 3.33% for tr, 2.5% for ll in subjects aged >=8 years; 5% for hn, 5% for ul, 3.33% for tr, 3.33% for ll in subjects aged 3 months to 7 years. % BSA for a body region= total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual=sum of %BSA across all 4 body regions and ranged from 0 to 100%,with higher values=greater extent of BSA involvement with AD. Eval-DB population was analysed. Here, 'n’ signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline (last observation up to and including the randomisation day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	129	125
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n=129, 125)	5.25 ± 9.588	5.22 ± 7.170
Change at Week 4 (n=60, 81)	1.16 ± 4.391	0.52 ± 5.164
Change at Week 8 (n=71, 80)	0.59 ± 6.202	-0.19 ± 6.659
Change at Week 12 (n=65, 76)	1.20 ± 6.821	0.26 ± 6.093
Change at Week 16 (n=75, 83)	1.25 ± 5.623	0.58 ± 5.848
Change at Week 20 (n=13, 12)	-1.29 ± 5.363	1.38 ± 6.846
Change at Week 24 (n=70, 78)	2.42 ± 9.213	2.15 ± 11.217
Change at Week 28 (n=12, 6)	-0.30 ± 6.323	-1.25 ± 5.906
Change at Week 32 (n=62, 72)	0.33 ± 7.623	0.84 ± 5.971
Change at Week 36 (n=8, 5)	0.44 ± 1.917	2.50 ± 3.623
Change at Week 40 (n=59, 64)	0.02 ± 6.752	0.89 ± 6.097
Change at Week 44 (n=13, 7)	-2.56 ± 4.889	0.57 ± 2.524
Change at Week 48 (=58, 64)	-0.37 ± 7.134	0.48 ± 6.295
Change at Week 52 (n=63, 63)	-1.23 ± 5.531	-1.91 ± 5.411

No statistical analyses for this end point

Secondary: Change from Baseline in Treatable %BSA: First Flare Free Period

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End point title

Change from Baseline in Treatable %BSA: First Flare Free Period

End point description

The extent (%) to which a body region was involved with AD was determined using handprint method. Four body regions evaluated: hn, ul, tr (including axillae) and ll (including buttocks). Total number of handprints=10 for hn, 20 for ul, 30 for tr, 40 for ll in subjects aged >=8 years; 20 for hn, 20 for ul, 30 for tr, 30 for ll in subjects aged 3 months to 7 years. Surface area of body region equivalent to 1 handprint: 10% for hn, 5% for ul, 3.33% for tr, 2.5% for ll in subjects aged >=8 years; 5% for hn, 5% for ul, 3.33% for tr, 3.33% for ll in subjects aged 3 months to 7 years. % BSA for a body region= total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual=sum of % BSA across all 4 body regions and ranged from 0 to 100%, with higher values=greater extent of BSA involvement with AD. Eval-DB population was analysed. Here, 'n’ signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline (last observation up to and including the randomisation day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	129	125
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n=129, 125)	5.25 ± 9.588	5.22 ± 7.170
Change at Week 4 (n=55, 80)	1.20 ± 4.487	0.53 ± 5.196
Change at Week 8 (n=43, 67)	0.21 ± 7.661	-0.10 ± 6.954
Change at Week 12 (n=37, 59)	0.96 ± 6.161	0.05 ± 6.309
Change at Week 16 (n=31, 52)	1.05 ± 5.929	0.28 ± 5.891
Change at Week 20 (n=1, 5)	5.00 ± 99999	-0.60 ± 9.659
Change at Week 24 (n=26, 46)	2.46 ± 8.669	3.09 ± 13.575
Change at Week 28 (n=2, 2)	-1.50 ± 2.121	-3.00 ± 12.728
Change at Week 32 (n=25, 39)	0.40 ± 8.581	0.91 ± 5.669
Change at Week 36 (n=1,1)	-2.00 ± 99999	0.00 ± 99999
Change at Week 40 (n=23, 33)	-0.46 ± 7.881	1.17 ± 6.153
Change at Week 44 (n=2, 3)	-3.25 ± 4.596	2.33 ± 3.215
Change at Week 48 (n=24, 32)	-0.85 ± 7.724	1.14 ± 6.959
Change at Week 52 (n=22, 30)	-1.50 ± 7.365	-1.47 ± 5.232

No statistical analyses for this end point

Secondary: Change from Baseline in Treatable %BSA: First Flare Period

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End point title

Change from Baseline in Treatable %BSA: First Flare Period

End point description

The extent (%) to which a body region was involved with AD was determined using handprint method. Four body regions evaluated: hn, ul, tr (including axillae) and ll (including buttocks). Total number of handprints=10 for hn, 20 for ul, 30 for tr, 40 for ll in subjects aged >=8 years; 20 for hn, 20 for ul, 30 for tr, 30 for ll in subjects aged 3 months to 7 years. Surface area of body region equivalent to 1 handprint: 10% for hn, 5% for ul, 3.33% for tr, 2.5% for ll in subjects aged >=8 years; 5% for hn, 5% for ul, 3.33% for tr, 3.33% for ll in subjects aged 3 months to 7 years. % BSA for a body region= total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual=sum of % BSA across all 4 body regions and ranged from 0 to 100%, with higher values=greater extent of BSA involvement with AD. Eval-DB population was analysed. Here, ‘N’:subjects evaluable for this endpoint and ‘n’:subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline (last observation up to and including the randomisation day), Weeks 0, 4, 8 and 12

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	96	81
Units: Units on a scale
arithmetic mean (standard deviation)
Change at Week 0 (n=96, 81)	8.27 ± 12.154	4.68 ± 6.304
Change at Week 4 (n=54, 47)	6.92 ± 9.704	4.17 ± 6.884
Change at Week 8 (n=33, 27)	4.95 ± 11.642	3.56 ± 6.646
Change at Week 12 (n=10, 11)	5.75 ± 10.499	3.39 ± 5.328

No statistical analyses for this end point

Secondary: Change from Baseline in Most Commonly Affected Atopic Dermatitis (AD) % BSA: DB Period

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End point title

Change from Baseline in Most Commonly Affected Atopic Dermatitis (AD) % BSA: DB Period

End point description

The investigators were required to draw the skin areas affected by AD for each subject in a body map and the most commonly affected BSA was documented. Eval-DB population included all randomised subjects with success in ISGA and EASI50 criteria as responders at randomisation and received at least 1 dose of study intervention in the DB period. Here, ‘n’ signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline (last observation up to and including the randomisation day), Weeks 24 and 52

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	129	125
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n=129, 125)	14.28 ± 13.957	10.77 ± 9.834
Change at Week 24 (n=72, 76)	2.29 ± 11.579	-0.20 ± 3.919
Change at Week 52 (n=73, 75)	-3.46 ± 10.536	-4.95 ± 7.731

No statistical analyses for this end point

Secondary: Night Time Itch Score: OL Run-in Period

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End point title

Night Time Itch Score: OL Run-in Period

End point description

The severity and frequency of itch (pruritus) during the night due to AD was assessed using a horizontal scale. Subjects 12 years of age or older were asked to assess their worst itching and frequency of itching due to AD during their most recent night’s sleep on a scale. Score ranged from 0 to 10, 0(no itch) 10 (worst itch imaginable). Eval-OL population included all subjects that received at least 1 dose of study intervention in the OL period. Here, ‘N’: number of subjects evaluable for this end point and ‘n’: number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline (last observation up to and including the randomisation day), Weeks 2, 4, 6 and 8

End point values	Crisaborole 2% BID
Number of subjects analysed	275
Units: Units on a scale
arithmetic mean (standard deviation)
Severity of night time itch: Baseline (n=248)	4.6 ± 3.02
Severity of night time itch: Week 2 (n=264)	2.9 ± 2.21
Severity of night time itch: Week 4 (n=266)	2.7 ± 2.25
Severity of night time itch: Week 6 (n=266)	2.5 ± 2.16
Severity of night time itch: Week 8 (n=266)	2.5 ± 2.19
Frequency of night time itch: Baseline (n=248)	4.4 ± 2.80
Frequency of night time itch: Week 2 (n=264)	2.8 ± 2.20
Frequency of night time itch: Week 4 (n=266)	2.7 ± 2.23
Frequency of night time itch: Week 6 (n=266)	2.4 ± 2.15
Frequency of night time itch: Week 8 (n=266)	2.4 ± 2.16

No statistical analyses for this end point

Secondary: Night Time Itch Score: DB Period

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End point title

Night Time Itch Score: DB Period

End point description

The severity and frequency of itch (pruritus) during the night due to AD was assessed using a horizontal scale. Subjects 12 years of age or older were asked to assess their worst itching and frequency of itching due to AD during their most recent night’s sleep on a scale. Score ranged from 0 to 10, 0(no itch) 10 (worst itch imaginable). Eval-DB population included all randomised subjects with success in ISGA and EASI50 criteria as responders at randomisation and received at least 1 dose of study intervention in the DB period. Here, ‘N’: number of subjects evaluable for this end point and ‘n’: number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline (last observation up to and including the randomisation day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	68	76
Units: Units on a scale
arithmetic mean (standard deviation)
Severity of night time itch: Baseline (n=68, 76)	1.9 ± 1.71	1.8 ± 1.79
Severity of night time itch: Week 4 (n=40, 58)	2.0 ± 1.83	1.2 ± 1.49
Severity of night time itch: Week 8 (n=34, 52)	1.6 ± 1.61	1.1 ± 1.59
Severity of night time itch: Week 12 (n=32, 52)	1.6 ± 1.74	1.1 ± 1.64
Severity of night time itch: Week 16 (n=44, 51)	1.7 ± 1.85	1.2 ± 1.70
Severity of night time itch: Week 20 (n=44, 49)	1.6 ± 1.86	1.3 ± 1.86
Severity of night time itch: Week 24 (n=39, 48)	1.6 ± 1.71	1.2 ± 1.79
Severity of night time itch: Week 28 (n=41, 48)	1.6 ± 1.69	1.2 ± 1.73
Severity of night time itch: Week 32 (n=37, 46)	1.4 ± 1.57	1.1 ± 1.74
Severity of night time itch: Week 36 (n=35, 46)	1.4 ± 1.56	1.1 ± 1.85
Severity of night time itch: Week 40 (n=36, 45)	1.4 ± 1.46	1.2 ± 1.95
Severity of night time itch: Week 44 (n=30, 45)	1.6 ± 1.69	1.2 ± 1.98
Severity of night time itch: Week 48 (n=29, 43)	1.6 ± 1.76	1.1 ± 1.93
Severity of night time itch: Week 52 (n=32, 40)	1.4 ± 1.69	1.2 ± 1.96
Frequency of night time itch: Baseline (n=68, 76)	1.9 ± 1.66	1.8 ± 1.79
Frequency of night time itch: Week 4 (n=40, 58)	1.9 ± 1.89	1.1 ± 1.43
Frequency of night time itch: Week 8 (n=34, 52)	1.6 ± 1.71	1.1 ± 1.55
Frequency of night time itch: Week 12 (n=32, 52)	1.5 ± 1.76	1.1 ± 1.64
Frequency of night time itch: Week 16 (n=44, 51)	1.6 ± 1.87	1.2 ± 1.64
Frequency of night time itch: Week 20 (44, 49)	1.6 ± 1.82	1.3 ± 1.82
Frequency of night time itch: Week 24 (n= 39, 48)	1.5 ± 1.71	1.2 ± 1.77
Frequency of night time itch: Week 28 (n=41, 48)	1.5 ± 1.71	1.2 ± 1.70
Frequency of night time itch: Week 32 (n=37, 46)	1.3 ± 1.56	1.0 ± 1.72
Frequency of night time itch: Week 36 (n=35, 46)	1.3 ± 1.57	1.1 ± 1.82
Frequency of night time itch: Week 40 (n=36, 45)	1.4 ± 1.53	1.2 ± 1.91
Frequency of night time itch: Week 44 (n=30, 45)	1.5 ± 1.71	1.2 ± 1.95
Frequency of night time itch: Week 48 (n= 29, 43)	1.6 ± 1.78	1.1 ± 1.87
Frequency of night time itch: Week 52 (n=32, 40 )	1.3 ± 1.70	1.2 ± 1.98

No statistical analyses for this end point

Secondary: Night Time Itch Score: First Flare Period

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End point title

Night Time Itch Score: First Flare Period

End point description

The severity and frequency of itch (pruritus) during the night due to AD was assessed using a horizontal scale. Subjects 12 years of age or older were asked to assess their worst itching and frequency of itching due to AD during their most recent night’s sleep on a scale. Score ranged from 0 to 10, 0(no itch) 10 (worst itch imaginable). Eval-DB population included all randomised subjects with success in ISGA and EASI50 criteria as responders at randomisation and received at least 1 dose of study intervention in the DB period. Here, ‘N’: number of subjects evaluable for this end point and ‘n’: number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Weeks 0, 4, 8 and 12

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	41	39
Units: Units on a scale
arithmetic mean (standard deviation)
Severity of night time itch: Week 0 (n=15, 17)	2.0 ± 1.12	2.0 ± 2.32
Severity of night time itch: Week 4 (n=41, 39)	2.0 ± 1.95	2.2 ± 2.18
Severity of night time itch: Week 8 (n=19, 15)	2.2 ± 1.73	2.8 ± 2.60
Severity of night time itch: Week 12 (n=9, 16)	1.8 ± 1.32	2.8 ± 2.03
Frequency of night time itch: Week 0 (n=15, 17)	2.0 ± 1.13	2.0 ± 2.32
Frequency of night time itch: Week 4 (n=41, 39)	2.0 ± 2.13	2.1 ± 2.11
Frequency of night time itch: Week 8 (n=19, 15)	2.1 ± 1.96	2.6 ± 2.54
Frequency of night time itch: Week 12 (n=9, 16)	1.3 ± 1.26	2.7 ± 2.09

No statistical analyses for this end point

Secondary: Night Time Itch Score: First Flare Free Period

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End point title

Night Time Itch Score: First Flare Free Period

End point description

The severity and frequency of itch (pruritus) during the night due to AD was assessed using a horizontal scale. Subjects 12 years of age or older were asked to assess their worst itching and frequency of itching due to AD during their most recent night’s sleep on a scale. Score ranged from 0 to 10, 0(no itch) 10 (worst itch imaginable). Eval-DB population included all randomised subjects with success in ISGA and EASI50 criteria as responders at randomisation and received at least 1 dose of study intervention in the DB period. Here, ‘N’: number of subjects evaluable for this end point and ‘n’: number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	68	76
Units: Units on a scale
arithmetic mean (standard deviation)
Severity of night time itch: Baseline (n=68, 76)	1.9 ± 1.71	1.8 ± 1.79
Severity of night time itch: Week 4 (n=38, 55)	2.0 ± 1.87	1.2 ± 1.49
Severity of night time itch: Week 8 (n=27, 46)	1.8 ± 1.68	1.2 ± 1.64
Severity of night time itch: Week 12 (n=22, 41)	1.5 ± 1.27	1.1 ± 1.72
Severity of night time itch: Week 16 (n=19, 38)	1.7 ± 1.30	1.2 ± 1.84
Severity of night time itch: Week 20 (n=18, 34)	1.6 ± 1.26	1.4 ± 1.99
Severity of night time itch: Week 24 (n=18, 33)	1.6 ± 1.23	1.2 ± 1.92
Severity of night time itch: Week 28 (n=17, 29)	1.6 ± 1.21	1.2 ± 1.86
Severity of night time itch: Week 32 (n=17, 27)	1.5 ± 1.27	1.2 ± 1.99
Severity of night time itch: Week 36 (n=17, 28)	1.5 ± 1.24	1.1 ± 2.02
Severity of night time itch: Week 40 (n=17, 25)	1.6 ± 1.24	1.1 ± 2.08
Severity of night time itch: Week 44 (n=16, 24)	1.9 ± 1.20	1.1 ± 2.26
Severity of night time itch: Week 48 (n=16, 24)	1.5 ± 1.27	1.2 ± 2.24
Severity of night time itch: Week 52 (n=12, 20)	1.6 ± 1.35	1.2 ± 2.29
Frequency of night time itch: Baseline (n=68, 76)	1.9 ± 1.66	1.8 ± 1.79
Frequency of night time itch: Week 4 (n=38, 55)	1.9 ± 1.93	1.1 ± 1.43
Frequency of night time itch: Week 8 (n=27, 46)	1.8 ± 1.80	1.1 ± 1.60
Frequency of night time itch: Week 12 (n=22, 41)	1.4 ± 1.31	1.1 ± 1.73
Frequency of night time itch: Week 16 (n=19, 38)	1.6 ± 1.29	1.2 ± 1.79
Frequency of night time itch: Week 20 (18, 34)	1.5 ± 1.16	1.3 ± 1.92
Frequency of night time itch: Week 24 (n=18, 33)	1.4 ± 1.21	1.2 ± 1.91
Frequency of night time itch: Week 28 (n=17, 29)	1.3 ± 1.19	1.2 ± 1.89
Frequency of night time itch: Week 32 (n=17, 27)	1.3 ± 1.24	1.1 ± 2.04
Frequency of night time itch: Week 36 (n=17, 28)	1.3 ± 1.22	1.1 ± 2.05
Frequency of night time itch: Week 40 (n=17, 25)	1.6 ± 1.37	1.1 ± 2.06
Frequency of night time itch: Week 44 (n=16, 24)	1.8 ± 1.22	1.2 ± 2.25
Frequency of night time itch: Week 48 (n=16, 24)	1.5 ± 1.32	1.3 ± 2.18
Frequency of night time itch: Week 52 (n=12, 20)	1.3 ± 1.38	1.2 ± 2.30

No statistical analyses for this end point

Secondary: AD Skin Pain Scores: OL Run-in Period

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End point title

AD Skin Pain Scores: OL Run-in Period

End point description

Subjects 12 years of age or older were asked to assess their worst skin pain due to AD at the analysis time, with the question: ‘AD skin pain right now’ using the skin pain numerical rating scale (NRS). Skin pain NRS was a 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "worst pain imaginable." Eval-OL population included all subjects that received at least 1 dose of study intervention in the OL period. Here, ‘N’: number of subjects evaluable for this end point and ‘n’: number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8

End point values	Crisaborole 2% BID
Number of subjects analysed	266
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n=248)	2.6 ± 2.60
Week 2 (n=264)	2.0 ± 1.96
Week 4 (n=266)	1.9 ± 2.03
Week 6 (n=266)	1.8 ± 2.08
Week 8 (n=266)	1.7 ± 2.06

No statistical analyses for this end point

Secondary: AD Skin Pain Scores: DB Period

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End point title

AD Skin Pain Scores: DB Period

End point description

Subjects 12 years of age or older were asked to assess their worst skin pain due to AD at the analysis time, with the question: ‘AD skin pain right now’ using the skin pain NRS. Skin pain NRS was a 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "worst pain imaginable." Eval-DB population included all randomised subjects with success in ISGA and EASI50 criteria as responders at randomisation and received at least 1 dose of study intervention in the DB period. Here, ‘N’: number of subjects evaluable for this end point and ‘n’: number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	68	76
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n=68, 76)	1.1 ± 1.34	1.2 ± 1.74
Week 4 (n=40, 58)	1.1 ± 1.55	0.7 ± 1.27
Week 8 (n=34, 52)	1.0 ± 1.09	1.0 ± 1.59
Week 12 (n=32, 52)	1.1 ± 1.69	0.9 ± 1.62
Week 16 (n=44, 51)	1.3 ± 1.90	1.1 ± 1.67
Week 20 (n=44, 49)	1.0 ± 1.49	1.1 ± 1.81
Week 24 (n=39, 48)	1.1 ± 1.52	1.0 ± 1.82
Week 28 (n=41, 48)	1.0 ± 1.54	1.0 ± 1.78
Week 32 (n=37, 46)	1.0 ± 1.53	0.8 ± 1.71
Week 36 (n=35, 46)	1.1 ± 1.61	0.9 ± 1.78
Week 40 (n=36, 45)	1.1 ± 1.49	1.1 ± 1.95
Week 44 (n=30, 45)	1.1 ± 1.67	1.1 ± 1.99
Week 48 (n=29, 43)	1.3 ± 1.64	0.9 ± 1.88
Week 52 (n=32, 40)	1.0 ± 1.62	1.0 ± 1.99

No statistical analyses for this end point

Secondary: AD Skin Pain Scores: First Flare Period

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End point title

AD Skin Pain Scores: First Flare Period

End point description

End point type

Secondary

End point timeframe

Weeks 0, 4, 8, 12

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	41	39
Units: Units on a scale
arithmetic mean (standard deviation)
Week 0 (n=15, 17)	1.2 ± 1.26	2.2 ± 2.01
Week 4 (n=41, 39)	1.4 ± 1.75	1.7 ± 1.94
Week 8 (n=19, 15)	1.3 ± 1.53	2.3 ± 2.15
Week 12 (n=9, 16)	2.0 ± 1.66	2.3 ± 2.05

No statistical analyses for this end point

Secondary: AD Skin Pain Scores: First Flare Free Period

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End point title

AD Skin Pain Scores: First Flare Free Period

End point description

End point type

Secondary

End point timeframe

Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	68	76
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n=68, 76)	1.1 ± 1.34	1.2 ± 1.74
Week 4 (n=38, 55)	1.2 ± 1.58	0.7 ± 1.30
Week 8 (n=27, 46)	1.0 ± 1.16	1.0 ± 1.65
Week 12 (n=22, 41)	0.9 ± 1.17	1.0 ± 1.75
Week 16 (n=19, 38)	1.1 ± 1.28	1.1 ± 1.83
Week 20 (n=18, 34)	1.1 ± 1.18	1.1 ± 2.02
Week 24 (n=18, 33)	1.2 ± 1.36	1.0 ± 1.97
Week 28 (n=17, 29)	1.0 ± 1.35	1.0 ± 2.04
Week 32 (n=17, 27)	1.1 ± 1.41	1.0 ± 2.06
Week 36 (n=17, 28)	1.2 ± 1.44	1.0 ± 2.08
Week 40 (n=17, 25)	1.2 ± 1.43	1.1 ± 2.21
Week 44 (n=16, 24)	1.2 ± 1.48	1.1 ± 2.37
Week 48 (n=16, 24)	1.3 ± 1.43	1.0 ± 2.28
Week 52 (n=12, 20)	1.1 ± 1.46	1.0 ± 2.32

No statistical analyses for this end point

Secondary: Patient/Observer Global Impression of Severity Score: OL Run-in Period

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End point title

Patient/Observer Global Impression of Severity Score: OL Run-in Period

End point description

Patient/Observer Global Impression of Severity (PGIS/OGIS) is a single item subject or observer rated measure of the subject’s AD condition severity at a given point in time using a 7-point rating scale, which ranges from 1 to 7, where 1=not present to 7=extremely severe. The PGIS was completed by all subjects ≥12 years of age and OGIS was completed by the observer for subjects 3 months-11 years of age. Eval-OL population included all subjects that received at least 1 dose of study intervention in the OL period. Here, ‘N’: number of subjects evaluable for this end point and ‘n’: number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8

End point values	Crisaborole 2% BID
Number of subjects analysed	269
Units: Units on a scale
arithmetic mean (standard deviation)
>= 12 years of age: Baseline (n=247)	3.8 ± 1.30
>= 12 years of age: Week 2 (n=268)	3.2 ± 1.08
>= 12 years of age: Week 4 (n=269)	3.1 ± 1.12
>= 12 years of age: Week 6 (n=269)	3.0 ± 1.16
>= 12 years of age: Week 8 (n=269)	3.0 ± 1.19
3 months to <12 years of age: Baseline (n=207)	4.4 ± 1.20
3 months to <12 years of age: Week 2 (n=222)	3.3 ± 1.13
3 months to <12 years of age: Week 4 (n=222)	3.3 ± 1.15
3 months to <12 years of age: Week 6 (n=222)	3.2 ± 1.21
3 months to <12 years of age: Week 8 (n=222)	3.1 ± 1.19

No statistical analyses for this end point

Secondary: Patient/Observer Global Impression of Severity Score: DB Period

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End point title

Patient/Observer Global Impression of Severity Score: DB Period

End point description

Patient/Observer Global Impression of Severity (PGIS/OGIS) is a single item subject or observer rated measure of the subject’s AD condition severity at a given point in time using a 7-point rating scale, which ranges from 1 to 7, where 1=not present to 7=extremely severe. The PGIS was completed by all subjects ≥12 years of age and OGIS was completed by the observer for subjects 3 months-11 years of age. Eval-DB population included all randomised subjects with success in ISGA and EASI50 criteria as responders at randomisation and received at least 1 dose of study intervention in the DB period. Here, ‘N’: number of subjects evaluable for this end point and ‘n’: number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	68	76
Units: Units on a scale
arithmetic mean (standard deviation)
>= 12 years of age: Baseline (n=68, 76)	2.6 ± 1.03	2.5 ± 0.90
>= 12 years of age: Week 4 (n=40, 58)	2.7 ± 1.14	2.3 ± 0.97
>= 12 years of age: Week 8 (n=34, 52)	2.6 ± 0.93	2.2 ± 1.02
>= 12 years of age: Week 12 (n=32, 52)	2.7 ± 1.05	2.2 ± 0.98
>= 12 years of age: Week 16 (n=44, 51)	2.7 ± 1.15	2.3 ± 1.06
>= 12 years of age: Week 20 (n=44, 49)	2.7 ± 0.98	2.4 ± 1.23
>= 12 years of age: Week 24 (n=39, 48)	2.6 ± 1.06	2.4 ± 1.29
>= 12 years of age: Week 28 (n=41, 48)	2.7 ± 1.04	2.4 ± 1.21
>= 12 years of age: Week 32 (n=37, 46)	2.6 ± 1.07	2.4 ± 1.19
>= 12 years of age: Week 36 (n=35, 46)	2.7 ± 1.15	2.4 ± 1.29
>= 12 years of age: Week 40 (n=36, 45)	2.6 ± 1.12	2.4 ± 1.34
>= 12 years of age: Week 44 (n=30, 45)	2.6 ± 1.18	2.5 ± 1.21
>= 12 years of age: Week 48 (n= 29, 43)	2.7 ± 1.27	2.4 ± 1.19
>= 12 years of age: Week 52 (n=32, 40)	2.4 ± 1.19	2.3 ± 1.26
3 months to <12 years of age: Baseline (n=58, 46)	2.6 ± 0.99	2.6 ± 0.83
3 months to <12 years of age: Week 4 (n=26, 28)	2.6 ± 1.14	2.4 ± 0.93
3 months to <12 years of age: Week 8 (n=29, 27)	2.3 ± 1.13	2.4 ± 1.03
3 months to <12 years of age: Week 12 (n=32, 23)	2.3 ± 0.99	2.2 ± 0.73
3 months to <12 years of age: Week 16 (n=32, 28)	2.4 ± 1.14	2.1 ± 0.77
3 months to <12 years of age: Week 20 (n=31, 32)	2.4 ± 1.03	2.2 ± 0.88
3 months to <12 years of age: Week 24 (n=32, 32)	2.4 ± 1.04	2.3 ± 1.02
3 months to <12 years of age: Week 28 (n=31, 29)	2.4 ± 1.08	2.0 ± 0.66
3 months to <12 years of age: Week 32 (n=27, 25)	2.1 ± 0.80	2.1 ± 0.64
3 months to <12 years of age: Week 36 (n=25, 22)	2.4 ± 1.18	2.0 ± 0.58
3 months to <12 years of age: Week 40 (n=25, 17)	2.2 ± 0.74	2.1 ± 0.67
3 months to <12 years of age: Week 44 (n=26, 21)	2.3 ± 1.05	2.0 ± 0.64
3 months to <12 years of age: Week 48 (n=26, 18)	2.2 ± 0.80	1.8 ± 0.53
3 months to <12 years of age: Week 52 (n=26, 16)	2.1 ± 1.00	1.7 ± 0.62

No statistical analyses for this end point

Secondary: Patient/Observer Global Impression of Severity Score: First Flare Period

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End point title

Patient/Observer Global Impression of Severity Score: First Flare Period

End point description

PGIS/OGIS is a single item subject or observer rated measure of the subject’s AD condition severity at a given point in time using a 7-point rating scale, which ranges from 1 to 7, where 1=not present to 7=extremely severe. The PGIS was completed by all subjects ≥12 years of age and OGIS was completed by the observer for subjects 3 months-11 years of age. Eval-DB population included all randomised subjects with success in ISGA and EASI50 criteria as responders at randomisation and received at least 1 dose of study intervention in the DB period. Here, ‘N’: number of subjects evaluable for this end point and ‘n’: number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Weeks 0, 4, 8 and 12

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	52	39
Units: Units on a scale
arithmetic mean (standard deviation)
>= 12 years of age: Week 0 (n= 15, 17)	2.8 ± 0.93	3.1 ± 1.10
>= 12 years of age: Week 4 (n=41, 39)	2.9 ± 0.98	2.9 ± 1.14
>= 12 years of age: Week 8 (n=19, 15)	3.1 ± 1.02	3.6 ± 1.17
>= 12 years of age: Week 12 (n=9, 16)	3.3 ± 1.56	3.1 ± 1.50
3 months to <12 years of age: Week 0 (n=15, 11)	2.8 ± 0.94	3.0 ± 0.79
3 months to <12 years of age: Week 4 (n=52, 36)	3.0 ± 1.19	2.8 ± 0.90
3 months to <12 years of age: Week 8 (n=23, 17)	2.9 ± 1.16	3.1 ± 1.03
3 months to <12 years of age: Week 12 (n=9, 6)	2.8 ± 0.95	3.4 ± 0.79

No statistical analyses for this end point

Secondary: Patient/Observer Global Impression of Severity Score: First Flare Free Period

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End point title

Patient/Observer Global Impression of Severity Score: First Flare Free Period

End point description

End point type

Secondary

End point timeframe

Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	68	76
Units: Units on a scale
arithmetic mean (standard deviation)
>= 12 years of age: Baseline (n=68, 76)	2.6 ± 1.03	2.5 ± 0.90
>= 12 years of age: Week 4 (n=40, 57)	2.7 ± 1.14	2.3 ± 0.98
>= 12 years of age: Week 8 (n=29, 47)	2.6 ± 1.00	2.3 ± 1.05
>= 12 years of age: Week 12 (n=22, 42)	2.6 ± 1.03	2.2 ± 1.03
>= 12 years of age: Week 16 (n=20, 38)	2.6 ± 1.04	2.1 ± 1.00
>= 12 years of age: Week 20 (n=18, 35)	2.7 ± 0.96	2.2 ± 1.10
>= 12 years of age: Week 24 (n=18, 33)	2.7 ± 1.06	2.2 ± 1.11
>= 12 years of age: Week 28 (n=17, 30)	2.7 ± 1.05	2.2 ± 1.07
>= 12 years of age: Week 32 (n=17, 27)	2.6 ± 1.05	2.1 ± 1.02
>= 12 years of age: Week 36 (n= 17, 28)	2.7 ± 1.05	2.1 ± 1.08
>= 12 years of age: Week 40 (n=17, 25)	2.7 ± 1.10	2.1 ± 1.10
>= 12 years of age: Week 44 (n=16, 24)	2.7 ± 1.10	2.3 ± 1.24
>= 12 years of age: Week 48 (n=16, 24)	2.6 ± 1.14	2.3 ± 1.28
>= 12 years of age: Week 52 (n=14, 21)	2.6 ± 1.15	2.0 ± 1.25
3 months to <12 years of age: Baseline (n=58, 46)	2.6 ± 0.99	2.6 ± 0.83
3 months to <12 years of age: Week 4 (n=26, 28)	2.6 ± 1.14	2.4 ± 0.93
3 months to <12 years of age: Week 8 (n=19, 22)	2.5 ± 1.28	2.3 ± 0.98
3 months to <12 years of age: Week 12 (n=18, 17)	2.3 ± 1.12	2.3 ± 0.78
3 months to <12 years of age: Week 16 (n=16, 16)	2.4 ± 1.14	2.0 ± 0.84
3 months to <12 years of age: Week 20 (n=11, 15)	2.3 ± 1.24	2.1 ± 0.83
3 months to <12 years of age: Week 24 (n=10, 14)	2.3 ± 1.47	1.9 ± 0.59
3 months to <12 years of age: Week 28 (n=9, 13)	2.4 ± 1.59	2.0 ± 0.57
3 months to <12 years of age: Week 32 (n=8, 13)	1.8 ± 0.75	2.1 ± 0.58
3 months to <12 years of age: Week 36 (n=8, 9)	2.6 ± 1.77	1.7 ± 0.56
3 months to <12 years of age: Week 40 (n=8, 7)	2.0 ± 0.99	1.8 ± 0.60
3 months to <12 years of age: Week 44 (n=8, 9)	2.7 ± 1.66	1.7 ± 0.56
3 months to <12 years of age: Week 48 (n=7,7)	2.1 ± 0.92	1.7 ± 0.41
3 months to <12 years of age: Week 52 (n=7, 6)	1.5 ± 0.50	1.6 ± 0.65

No statistical analyses for this end point

Secondary: Patient/Observer Global Impression of Change Score: OL Run-in Period

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End point title

Patient/Observer Global Impression of Change Score: OL Run-in Period

End point description

Patient/Observer Global Impression of Change (PGIC/OGIC) is a single item instrument using 7-point rating scale and was used to determine global improvement at a given point in time since the start of study drug. The scores ranged from 1=very much improved to 7=very much worse. The PGIC was completed by all subjects ≥12 years of age and OGIC was completed by the observer for subjects 3 months-11 years of age. Eval-OL population included all subjects that received at least 1 dose of study intervention in the OL period. Here, ‘N’: number of subjects evaluable for this end point and ‘n’: number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Weeks 2, 4, 6 and 8

End point values	Crisaborole 2% BID
Number of subjects analysed	273
Units: Units on a scale
arithmetic mean (standard deviation)
>= 12 years of age: Week 2 (n=271)	2.8 ± 1.17
>= 12 years of age: Week 4 (n=273)	2.7 ± 1.32
>= 12 years of age: Week 6 (n=273)	2.6 ± 1.36
>= 12 years of age: Week 8 (n=273)	2.6 ± 1.46
3 months to <12 years: Week 2 (n=222)	2.6 ± 1.21
3 months to <12 years: Week 4 (n=222)	2.6 ± 1.36
3 months to <12 years: Week 6 (n=222)	2.5 ± 1.50
3 months to <12 years: Week 8 (n=222)	2.5 ± 1.57

No statistical analyses for this end point

Secondary: Patient/Observer Global Impression of Change Score: DB Period

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End point title

Patient/Observer Global Impression of Change Score: DB Period

End point description

PGIC/OGIC is a single item instrument using 7-point rating scale and was used to determine global improvement at a given point in time since the start of study drug. The scores ranged from 1=very much improved to 7=very much worse. The PGIC was completed by all subjects ≥12 years of age and OGIC was completed by the observer for subjects 3 months-11 years of age. Eval-DB population included all randomised subjects with success in ISGA and EASI50 criteria as responders at randomisation and received at least 1 dose of study intervention in the DB period. Here, ‘N’: number of subjects evaluable for this end point and ‘n’: number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	69	78
Units: Units on a scale
arithmetic mean (standard deviation)
>= 12 years of age: Baseline (n=69, 78)	1.8 ± 0.68	1.8 ± 0.75
>= 12 years of age: Week 4 (n=32, 51)	1.9 ± 0.84	1.8 ± 0.76
>= 12 years of age: Week 8 (n=36, 50)	2.0 ± 0.74	1.9 ± 0.88
>= 12 years of age: Week 12 (n=32, 49)	2.0 ± 0.76	1.9 ± 1.00
>= 12 years of age: Week 16 (n=42, 52)	2.1 ± 1.00	1.8 ± 0.79
>= 12 years of age: Week 20 (n=21, 21)	2.3 ± 1.10	1.6 ± 0.80
>= 12 years of age: Week 24 (n=37, 47)	1.7 ± 0.70	1.8 ± 1.10
>= 12 years of age: Week 28 (n=18, 17)	2.2 ± 1.06	1.6 ± 0.80
>= 12 years of age: Week 32 (n=34, 45)	1.7 ± 0.72	1.8 ± 1.26
>= 12 years of age: Week 36 (n=17, 17)	1.9 ± 0.93	1.8 ± 0.66
>= 12 years of age: Week 40 (n=34, 47)	1.8 ± 0.91	1.8 ± 1.10
>= 12 years of age: Week 44	1.8 ± 0.79	1.8 ± 0.75
>= 12 years of age: Week 48 (n=30, 43)	1.5 ± 0.63	1.9 ± 1.34
>= 12 years of age: Week 52 (n=32, 43)	1.8 ± 0.76	1.6 ± 1.01
3 months to <12 years of age: Baseline (n=60, 47)	1.5 ± 0.60	1.6 ± 0.61
3 months to <12 years of age: Week 4 (n=24, 24)	1.7 ± 0.95	2.0 ± 1.23
3 months to <12 years of age: Week 8 (n=30, 24)	1.5 ± 0.57	1.8 ± 0.98
3 months to <12 years of age: Week 12 (n=29, 26)	1.6 ± 0.68	1.5 ± 0.65
3 months to <12 years of age: Week 16 (n=26, 28)	1.8 ± 0.97	1.5 ± 0.58
3 months to <12 years of age: Week 20 (n=16, 17)	1.9 ± 0.72	1.4 ± 0.62
3 months to <12 years of age: Week 24 (n=27, 29)	1.7 ± 0.90	1.7 ± 0.77
3 months to <12 years of age: Week 28 (n=16, 19)	1.6 ± 0.73	1.4 ± 0.68
3 months to <12 years of age: Week 32 (n=25, 24)	1.9 ± 1.24	1.8 ± 1.09
3 months to <12 years of age: Week 36 (n=13, 15)	1.6 ± 0.51	1.5 ± 0.64
3 months to <12 years of age: Week 40 (n= 21, 16)	1.9 ± 0.85	1.7 ± 0.87
3 months to <12 years of age: Week 44 (n=13, 12)	1.6 ± 0.51	1.8 ± 1.14
3 months to <12 years of age: Week 48 (n=22, 20)	1.6 ± 0.67	1.6 ± 0.89
3 months to <12 years of age: Week 52 (n= 29, 20)	1.6 ± 0.78	1.5 ± 0.60

No statistical analyses for this end point

Secondary: Patient/Observer Global Impression of Change Score: First Flare Period

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End point title

Patient/Observer Global Impression of Change Score: First Flare Period

End point description

End point type

Secondary

End point timeframe

Weeks 0, 4, 8 and 12

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	46	44
Units: Units on a scale
arithmetic mean (standard deviation)
>= 12 years of age: Week 0 (n=43, 44)	3.8 ± 1.56	3.1 ± 1.51
>= 12 years of age: Week 4 (n=21, 24)	2.7 ± 1.42	2.9 ± 1.30
>= 12 years of age: Week 8 (n=13, 15)	2.4 ± 0.51	3.2 ± 1.26
>= 12 years of age: Week 12 (n=3, 7)	2.7 ± 0.58	3.7 ± 1.11
3 months to <12 years of age: Week 0 (n=46, 33)	3.8 ± 1.84	3.3 ± 1.53
3 months to <12 years of age: Week 4 (n=28, 21)	2.4 ± 0.95	2.6 ± 0.97
3 months to <12 years of age: Week 8 (n=18, 11)	2.3 ± 0.97	3.0 ± 1.41
3 months to <12 years of age: Week 12 (n=5, 2)	2.4 ± 0.55	4.5 ± 0.71

No statistical analyses for this end point

Secondary: Patient/Observer Global Impression of Change Score: First Flare Free Period

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End point title

Patient/Observer Global Impression of Change Score: First Flare Free Period

End point description

End point type

Secondary

End point timeframe

Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	69	78
Units: Units on a scale
arithmetic mean (standard deviation)
>= 12 years of age: Baseline (n=69, 78)	1.8 ± 0.68	1.8 ± 0.75
>= 12 years of age: Week 4 (n=30, 51)	2.0 ± 0.83	1.8 ± 0.76
>= 12 years of age: Week 8 (n=25, 44)	2.1 ± 0.73	1.9 ± 0.90
>= 12 years of age: Week 12 (n=20, 40)	2.0 ± 0.86	2.0 ± 1.04
>= 12 years of age: Week 16 (n=19, 37)	2.3 ± 1.29	1.8 ± 0.76
>= 12 years of age: Week 20 (n=8, 13)	1.9 ± 0.64	1.5 ± 0.52
>= 12 years of age: Week 24 (n=17, 31)	1.8 ± 0.83	1.6 ± 0.80
>= 12 years of age: Week 28 (n=7, 9)	1.9 ± 0.69	1.4 ± 0.53
>= 12 years of age: Week 32 (n=16, 27)	1.7 ± 0.60	1.6 ± 0.97
>= 12 years of age: Week 36 (n=6,7)	2.0 ± 1.26	1.4 ± 0.53
>= 12 years of age: Week 40 (n=17, 26)	1.7 ± 0.85	1.5 ± 0.58
>= 12 years of age: Week 44 (n=7, 9)	2.1 ± 1.07	1.6 ± 0.73
>= 12 years of age: Week 48 (n=17, 24)	1.5 ± 0.62	1.6 ± 1.10
>= 12 years of age: Week 52 (n=15, 23)	1.7 ± 0.88	1.4 ± 0.50
3 months to <12 years of age: Baseline (n=60, 47)	1.5 ± 0.60	1.6 ± 0.61
3 months to <12 years of age: Week 4 (n=22, 24)	1.8 ± 0.97	2.0 ± 1.23
3 months to <12 years of age: Week 8 (n=15, 18)	1.7 ± 0.62	1.8 ± 1.00
3 months to <12 years of age: Week 12 (n=15, 18)	1.7 ± 0.80	1.6 ± 0.62
3 months to <12 years of age: Week 16 (n=10, 14)	1.6 ± 0.97	1.6 ± 0.63
3 months to <12 years of age: Week 20 (n=3, 9)	1.7 ± 0.58	1.4 ± 0.73
3 months to <12 years of age: Week 24 (n=7, 14)	1.6 ± 0.53	1.6 ± 0.84
3 months to <12 years of age: Week 28 (n=3, 9)	1.0 ± 0.00	1.3 ± 0.71
3 months to <12 years of age: Week 32 (n=8, 11)	1.6 ± 0.52	1.7 ± 0.90
3 months to <12 years of age: Week 36 (n=1, 8)	1.0 ± 99999	1.5 ± 0.53
3 months to <12 years of age: Week 40 (n=7, 8)	1.7 ± 0.76	1.3 ± 0.46
3 months to <12 years of age: Week 44 (n=1, 5)	1.0 ± 99999	1.4 ± 0.55
3 months to <12 years of age: Week 48 (n=6, 7)	1.5 ± 0.55	1.3 ± 0.49
3 months to <12 years of age: Week 52 (n=7, 7)	1.1 ± 0.38	1.3 ± 0.49

No statistical analyses for this end point

Secondary: Medical Outcomes Study Sleep Scale Score: OL Run-in Period

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End point title

Medical Outcomes Study Sleep Scale Score: OL Run-in Period

End point description

The Medical Outcomes Study (MOS) Sleep Scale is a 12-item measure that is segregated into subscales addressing seven sleep domains (i.e. sleep disturbance, snoring, short of breath(B) or headache(H), adequacy of sleep, somnolence, sleep problems index I and sleep problems index II). An additional single item assessed quantity of sleep. The sleep domains and problems index I and problems index II were scored on a range of 0-100, and higher scores indicated worse outcomes. The quantity of sleep scores ranged from 0 to 24 (number of hours slept). The optimal sleep sub-scale score is a binary outcome derived from Sleep Quantity (SQ): the response is Yes (or 1) if SQ= 7 or 8 hours per night. Observed scores for each individual sleep domain and quantity of sleep are reported in this end point. Eval-OL population was analysed. Here, ‘N’: number of subjects evaluable for this end point and ‘n’: number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8

End point values	Crisaborole 2% BID
Number of subjects analysed	273
Units: Units on a scale
arithmetic mean (standard deviation)
Quantity Hours Slept Score: Baseline (n=268)	7.4 ± 3.27
Quantity Hours Slept Score: Week 2 (n=271)	7.6 ± 3.06
Quantity Hours Slept Score: Week 4 (n=273)	7.6 ± 3.24
Quantity Hours Slept Score: Week 6 (n=273)	7.9 ± 3.43
Quantity Hours Slept Score: Week 8 (n=273)	7.8 ± 3.41
Optimal Hours Slept Score: Baseline (n=268)	0.4 ± 0.50
Optimal Hours Slept Score: Week 2 (n=271)	0.5 ± 0.50
Optimal Hours Slept Score: Week 4 (n=273)	0.5 ± 0.50
Optimal Hours Slept Score: Week 6 (n=273)	0.5 ± 0.50
Optimal Hours Slept Score: Week 8 (n=273)	0.5 ± 0.50
Short of B or H score: Baseline(n=268)	27.8 ± 15.18
Short of B or H score: Week 2 (n=271)	27.6 ± 13.98
Short of B or H score: Week 4 (n=273)	27.0 ± 14.56
Short of B or H score: Week 6 (n=273)	27.0 ± 13.95
Short of B or H score: Week 8 (n=273)	26.4 ± 14.00
Snoring Score: Baseline (n=268)	43.3 ± 27.34
Snoring Score: Week 2 (n=271)	41.1 ± 26.73
Snoring Score: Week 4 (n=273)	41.0 ± 26.02
Snoring Score: Week 6 (n=273)	40.9 ± 26.44
Snoring Score: Week 8 (n=273)	40.5 ± 26.09
Sleep Disturbance Score: Baseline (n=268)	45.0 ± 21.27
Sleep Disturbance Score: Week 2 (n= 271)	40.0 ± 20.21
Sleep Disturbance Score: Week 4 (n=273)	40.3 ± 21.20
Sleep Disturbance Score: Week 6 (n=273)	38.5 ± 20.25
Sleep Disturbance Score: Week 8 (n=273)	38.6 ± 20.93
Sleep Adequacy Score: Baseline (n=268)	63.0 ± 19.99
Sleep Adequacy Score: Week 2 (n=271)	66.1 ± 20.64
Sleep Adequacy Score: Week 4 (n=273)	65.5 ± 20.67
Sleep Adequacy Score: Week 6 (n=273)	66.8 ± 20.12
Sleep Adequacy Score: Week 8 (n=273)	67.3 ± 20.33
Sleep Somnolence Score: Baseline (n=268)	44.9 ± 18.01
Sleep Somnolence Score: Week 2 (n=271)	42.5 ± 17.19
Sleep Somnolence Score: Week 4 (n=273)	42.5 ± 18.12
Sleep Somnolence Score: Week 6 (n=273)	42.5 ± 17.93
Sleep Somnolence Score: Week 8 (n=273)	42.5 ± 19.08
Sleep Problems Index I Score: Baseline (n=268)	38.3 ± 14.74
Sleep Problems Index I Score: Week 2 (n=271)	35.3 ± 13.83
Sleep Problems Index I Score: Week 4 (n=273)	36.1 ± 14.97
Sleep Problems Index I Score: Week 6 (n=273)	34.9 ± 14.08
Sleep Problems Index I Score: Week 8 (n=273)	34.7 ± 14.03
Sleep Problems Index II Score: Baseline (n=268)	41.5 ± 15.39
Sleep Problems Index II Score: Week 2 (n=271)	37.7 ± 14.67
Sleep Problems Index II Score: Week 4 (n=273)	38.1 ± 15.73
Sleep Problems Index II Score: Week 6 (n=273)	36.9 ± 14.82
Sleep Problems Index II Score: Week 8 (n=273)	36.6 ± 15.13

No statistical analyses for this end point

Secondary: Medical Outcomes Study Sleep Scale Score: DB Period

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End point title

Medical Outcomes Study Sleep Scale Score: DB Period

End point description

The MOS Sleep Scale is a 12-item measure that is segregated into subscales addressing seven sleep domains (i.e. sleep disturbance, snoring, short of breath or headache, adequacy of sleep, somnolence, sleep problems index I and sleep problems index II). An additional single item assessed quantity of sleep. The sleep domains and problems index I and problems index II were scored on a range of 0-100, and higher scores indicated worse outcomes. The quantity of sleep scores ranged from 0 to 24 (number of hours slept). The optimal sleep sub-scale score is a binary outcome derived from SQ: the response is Yes (or 1) if SQ= 7 or 8 hours per night. Observed scores for each individual sleep domain and quantity of sleep are reported in this end point. Eval-DB population was analysed. Here, ‘N’: number of subjects evaluable for this end point and ‘n’: number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline (the last observation up to and including Day 1 of DB period),Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	69	78
Units: Units on a scale
arithmetic mean (standard deviation)
Quantity Hours Slept Score: Baseline (n=69, 78)	8.3 ± 3.79	7.5 ± 2.42
Quantity Hours Slept Score: Week 4 (n=31, 51)	8.9 ± 4.55	8.1 ± 3.32
Quantity Hours Slept Score: Week 8 (n=36, 50)	8.1 ± 3.31	7.8 ± 3.72
Quantity Hours Slept Score: Week 12 (n=32, 49)	8.8 ± 4.46	7.5 ± 3.18
Quantity Hours Slept Score: Week 16 (n=42, 52)	8.2 ± 3.89	8.1 ± 4.35
Quantity Hours Slept Score: Week 20 (n=21, 21)	6.9 ± 1.28	7.3 ± 1.49
Quantity Hours Slept Score: Week 24 (n=37, 47)	8.0 ± 4.21	8.0 ± 4.33
Quantity Hours Slept Score: Week 28 (n=18, 17)	8.4 ± 5.20	7.2 ± 1.38
Quantity Hours Slept Score: Week 32 (n=34, 45)	9.2 ± 5.64	8.3 ± 3.70
Quantity Hours Slept Score: Week 36 (n=17, 17)	6.9 ± 1.58	7.2 ± 1.48
Quantity Hours Slept Score: Week 40 (n=34, 47)	8.1 ± 4.39	8.1 ± 3.92
Quantity Hours Slept Score: Week 44 (n=18, 17)	7.1 ± 2.04	6.7 ± 0.99
Quantity Hours Slept Score: Week 48 (n=30, 43)	7.6 ± 3.88	7.7 ± 3.06
Quantity Hours Slept Score: Week 52 (n=32, 43)	7.7 ± 4.30	7.7 ± 3.12
Optimal Hours Slept Score: Baseline (n=69, 78)	0.5 ± 0.50	0.6 ± 0.50
Optimal Hours Slept Score: Week 4 (n=31, 51)	0.6 ± 0.50	0.6 ± 0.50
Optimal Hours Slept Score: Week 8 (n=36, 50)	0.7 ± 0.47	0.6 ± 0.49
Optimal Hours Slept Score: Week 12 (n=32, 49)	0.4 ± 0.50	0.6 ± 0.50
Optimal Hours Slept Score: Week 16 (n=42, 52)	0.5 ± 0.50	0.6 ± 0.50
Optimal Hours Slept Score: Week 20 (n=21, 21)	0.7 ± 0.46	0.5 ± 0.51
Optimal Hours Slept Score: Week 24 (n=37, 47)	0.4 ± 0.50	0.5 ± 0.51
Optimal Hours Slept Score: Week 28 (n=18, 17)	0.4 ± 0.51	0.5 ± 0.51
Optimal Hours Slept Score: Week 32 (n=34, 45)	0.5 ± 0.51	0.6 ± 0.50
Optimal Hours Slept Score: Week 36 (n=17, 17)	0.5 ± 0.51	0.6 ± 0.51
Optimal Hours Slept Score: Week 40 (n=34, 47)	0.5 ± 0.51	0.4 ± 0.49
Optimal Hours Slept Score: Week 44 (n=18, 17)	0.6 ± 0.51	0.7 ± 0.47
Optimal Hours Slept Score: Week 48 (n=30, 43)	0.6 ± 0.50	0.4 ± 0.50
Optimal Hours Slept Score: Week 52 (n=32, 43)	0.4 ± 0.49	0.5 ± 0.51
Short of B or H score: Baseline(n=69, 78)	24.1 ± 9.44	27.2 ± 15.45
Short of B or H score: Week 4 (n=32, 51)	23.8 ± 11.85	23.9 ± 9.81
Short of B or H score: Week 8 (n=36, 50)	24.4 ± 10.81	25.2 ± 12.66
Short of B or H score: Week 12 (n=32, 49)	25.0 ± 10.16	26.5 ± 13.16
Short of B or H score: Week 16 (n=42, 52)	26.2 ± 12.87	25.0 ± 11.11
Short of B or H score: Week 20 (n=21, 21)	24.8 ± 10.78	29.5 ± 18.57
Short of B or H score: Week 24 (n=37, 47)	27.6 ± 15.88	27.7 ± 13.55
Short of B or H score: Week 28 (n=18, 17)	27.8 ± 19.57	29.4 ± 18.86
Short of B or H score: Week 32 (n=34, 45)	26.5 ± 12.76	23.1 ± 10.41
Short of B or H score: Week 36 (n=17, 17)	25.9 ± 11.76	23.5 ± 14.55
Short of B or H score: Week 40 (n=34, 47)	25.3 ± 12.37	26.0 ± 13.13
Short of B or H score: Week 44 (n=18, 17)	28.9 ± 17.11	27.1 ± 14.04
Short of B or H score: Week 48 (n=30, 43)	25.3 ± 11.67	26.5 ± 14.29
Short of B or H score: Week 52 (n=32, 43)	1.3 ± 12.38	-0.5 ± 16.61
Snoring Score: Baseline (n=69, 78)	42.9 ± 26.41	37.2 ± 23.40
Snoring Score: Week 4 (n=32, 51)	46.9 ± 27.17	36.5 ± 21.43
Snoring Score: Week 8 (n=36, 50)	47.2 ± 26.25	36.8 ± 22.99
Snoring Score: Week 12 (n=32, 49)	45.6 ± 27.93	34.7 ± 21.12
Snoring Score: Week 16 (n=42, 52)	43.3 ± 24.96	35.0 ± 20.15
Snoring Score: Week 20 (n=21, 21)	41.9 ± 27.50	30.5 ± 17.46
Snoring Score: Week 24 (n=37, 47)	50.3 ± 27.74	39.6 ± 24.13
Snoring Score: Week 28 (n=18, 17)	45.6 ± 28.95	31.8 ± 21.28
Snoring Score: Week 32 (n=34, 45)	42.4 ± 24.50	39.1 ± 22.55
Snoring Score: Week 36 (n=17, 17)	37.6 ± 21.07	31.8 ± 18.79
Snoring Score: Week 40 (n=34, 47)	44.1 ± 26.87	37.4 ± 21.52
Snoring Score: Week 44 (n=18, 17)	36.7 ± 24.97	34.1 ± 19.70
Snoring Score: Week 48 (n=30, 43)	44.0 ± 22.53	37.2 ± 23.74
Snoring Score: Week 52 (n=32, 43)	45.6 ± 23.41	37.2 ± 22.07
Sleep Disturbance Score: Baseline (n=69, 78)	38.3 ± 18.74	34.8 ± 17.51
Sleep Disturbance Score: Week 4 (n=32, 51)	33.7 ± 15.01	32.2 ± 14.92
Sleep Disturbance Score: Week 8 (n=36, 50)	32.9 ± 13.80	35.3 ± 15.70
Sleep Disturbance Score: Week 12 (n=32, 49)	35.1 ± 16.20	32.8 ± 16.90
Sleep Disturbance Score: Week 16 (n=42, 52)	38.6 ± 19.44	30.8 ± 15.43
Sleep Disturbance Score: Week 20 (n=21, 21)	38.7 ± 22.89	32.1 ± 13.85
Sleep Disturbance Score: Week 24 (n=37, 47)	32.2 ± 19.95	36.3 ± 18.02
Sleep Disturbance Score: Week 28 (n=18, 17)	39.3 ± 22.69	37.2 ± 16.40
Sleep Disturbance Score: Week 32 (n=34, 45)	34.2 ± 20.09	32.0 ± 14.20
Sleep Disturbance Score: Week 36 (n=17, 17)	38.2 ± 23.61	32.2 ± 16.82
Sleep Disturbance Score: Week 40 (n=34, 47)	34.7 ± 18.96	33.0 ± 16.83
Sleep Disturbance Score: Week 44 (n=18, 17)	32.9 ± 23.13	38.9 ± 16.87
Sleep Disturbance Score: Week 48 (n=30, 43)	36.3 ± 18.59	32.1 ± 16.29
Sleep Disturbance Score: Week 52 (n=32, 43)	35.9 ± 19.59	32.9 ± 17.59
Sleep Adequacy Score: Baseline (n=69, 78)	68.6 ± 18.25	69.1 ± 21.69
Sleep Adequacy Score: Week 4 (n=32, 51)	70.6 ± 20.15	71.6 ± 18.80
Sleep Adequacy Score: Week 8 (n=36, 50)	72.5 ± 16.45	72.6 ± 20.58
Sleep Adequacy Score: Week 12 (n=32, 49)	71.9 ± 22.92	68.2 ± 21.47
Sleep Adequacy Score: Week 16 (n=42, 52)	73.3 ± 20.20	69.0 ± 18.71
Sleep Adequacy Score: Week 20 (n=21, 21)	70.5 ± 21.56	67.6 ± 17.86
Sleep Adequacy Score: Week 24 (n=37, 47)	71.6 ± 21.02	67.4 ± 20.59
Sleep Adequacy Score: Week 28 (n=18, 17)	71.7 ± 22.03	71.2 ± 21.47
Sleep Adequacy Score: Week 32 (n=34, 45)	74.7 ± 21.21	72.4 ± 19.67
Sleep Adequacy Score: Week 36 (n=17, 17)	74.1 ± 22.38	68.8 ± 15.76
Sleep Adequacy Score: Week 40 (n=34, 47)	68.5 ± 21.34	69.1 ± 18.51
Sleep Adequacy Score: Week 44 (n=18, 17)	72.2 ± 22.90	70.0 ± 21.79
Sleep Adequacy Score: Week 48 (n=30, 43)	73.0 ± 18.96	70.2 ± 19.70
Sleep Adequacy Score: Week 52 (n=32, 43)	70.0 ± 20.48	68.6 ± 22.74
Sleep Somnolence Score: Baseline (n= 69, 78)	40.3 ± 17.05	41.8 ± 18.51
Sleep Somnolence Score: Week 4 (n=32, 51)	39.6 ± 15.23	42.4 ± 18.13
Sleep Somnolence Score: Week 8 (n=36, 50)	36.5 ± 10.75	40.1 ± 18.78
Sleep Somnolence Score: Week 12 (n=32, 49)	41.7 ± 18.86	40.4 ± 18.48
Sleep Somnolence Score: Week 16 (n=42, 52)	37.1 ± 16.00	39.1 ± 17.06
Sleep Somnolence Score: Week 20 (n=21, 21)	41.3 ± 19.62	37.5 ± 17.82
Sleep Somnolence Score: Week 24 (n=37, 47)	39.5 ± 17.02	43.4 ± 18.06
Sleep Somnolence Score: Week 28 (n=18, 17)	44.4 ± 21.57	41.2 ± 19.33
Sleep Somnolence Score: Week 32 (n=34, 45)	43.7 ± 21.16	41.5 ± 15.63
Sleep Somnolence Score: Week 36 (n=17, 17)	34.9 ± 17.41	39.2 ± 14.70
Sleep Somnolence Score: Week 40 (n=34, 47)	38.6 ± 17.96	43.3 ± 14.70
Sleep Somnolence Score: Week 44 (n=18, 17)	39.3 ± 17.84	44.3 ± 16.99
Sleep Somnolence Score: Week 48 (n=30, 43)	41.3 ± 15.40	42.3 ± 13.48
Sleep Somnolence Score: Week 52 (n=32, 43)	-1.3 ± 15.92	-4.0 ± 19.90
Sleep Problems Index I Score: Baseline (n=69, 78)	33.4 ± 12.63	33.2 ± 14.19
Sleep Problems Index I Score: Week 4 (n=32, 51)	31.4 ± 13.22	31.6 ± 11.53
Sleep Problems Index I Score: Week 8 (n=36, 50)	29.6 ± 10.77	31.5 ± 13.98
Sleep Problems Index I Score: Week 12 (n=32, 49)	32.2 ± 14.36	33.3 ± 12.89
Sleep Problems Index I Score: Week 16 (n=42, 52)	32.1 ± 14.44	31.8 ± 12.14
Sleep Problems Index I Score: Week 20 (n=21, 21)	34.0 ± 16.21	32.9 ± 13.01
Sleep Problems Index I Score: Week 24 (n=37, 47)	30.9 ± 14.92	34.6 ± 13.63
Sleep Problems Index I Score: Week 28 (n=18, 17)	34.4 ± 18.22	32.9 ± 13.74
Sleep Problems Index I Score: Week 32 (n=34, 45)	31.7 ± 14.10	30.5 ± 11.72
Sleep Problems Index I Score: Week 36 (n=17, 17)	31.4 ± 18.11	31.6 ± 12.86
Sleep Problems Index I Score: Week 40 (n=34, 47)	33.0 ± 15.07	33.7 ± 13.55
Sleep Problems Index I Score: Week 44 (n=18, 17)	32.4 ± 18.32	33.5 ± 13.25
Sleep Problems Index I Score: Week 48 (n=30, 43)	33.3 ± 15.06	32.0 ± 12.20
Sleep Problems Index I Score: Week 52 (n=32, 43)	32.4 ± 13.92	32.6 ± 14.08
Sleep Problems Index II Score: Baseline (n=69, 78)	35.5 ± 13.20	34.4 ± 14.17
Sleep Problems Index II Score: Week 4 (n=32, 51)	32.6 ± 11.70	32.1 ± 11.57
Sleep Problems Index II Score: Week 8 (n=36, 50)	31.4 ± 10.70	33.1 ± 13.16
Sleep Problems Index II Score: Week 12 (n=32, 49)	33.2 ± 14.40	33.2 ± 13.21
Sleep Problems Index II Score: Week 16 (n=42, 52)	33.9 ± 15.58	32.0 ± 11.95
Sleep Problems Index II Score: Week 20 (n=21, 21)	35.9 ± 17.75	33.1 ± 11.87
Sleep Problems Index II Score: Week 24 (n=37, 47)	32.1 ± 15.49	35.9 ± 13.54
Sleep Problems Index II Score: Week 28 (n=18, 17)	36.7 ± 18.79	35.0 ± 13.07
Sleep Problems Index II Score: Week 32 (n=34, 45)	33.5 ± 14.89	31.6 ± 11.07
Sleep Problems Index II Score: Week 36 (n=17, 17)	33.5 ± 19.04	32.2 ± 12.20
Sleep Problems Index II Score: Week 40 (n=34, 47)	33.7 ± 15.62	33.9 ± 12.86
Sleep Problems Index II Score: Week 44 (n=18,17)	33.0 ± 18.97	36.9 ± 13.73
Sleep Problems Index II Score: Week 48 (n=30, 43)	33.7 ± 15.44	32.9 ± 12.13
Sleep Problems Index II Score: Week 52 (n=32, 43)	33.8 ± 14.86	33.0 ± 13.66

No statistical analyses for this end point

Secondary: Medical Outcomes Study Sleep Scale Score: First Flare Period

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End point title

Medical Outcomes Study Sleep Scale Score: First Flare Period

End point description

End point type

Secondary

End point timeframe

Weeks 0, 4, 8 and 12

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	43	44
Units: Units on a scale
arithmetic mean (standard deviation)
Quantity Hours Slept Score: Week 0 (n=42, 44)	7.3 ± 2.28	7.6 ± 3.56
Quantity Hours Slept Score: Week 4 (n=21, 24)	8.2 ± 3.88	7.3 ± 1.55
Quantity Hours Slept Score: Week 8 (n=13, 15)	8.3 ± 3.45	6.9 ± 1.68
Quantity Hours Slept Score: Week 12 (n=3, 7)	8.0 ± 1.00	7.3 ± 1.70
Optimal Hours Slept Score: Week 0 (n=42, 44)	0.6 ± 0.49	0.4 ± 0.50
Optimal Hours Slept Score: Week 4 (n=21, 24)	0.5 ± 0.51	0.6 ± 0.50
Optimal Hours Slept Score: Week 8 (n=13, 15)	0.5 ± 0.52	0.5 ± 0.52
Optimal Hours Slept Score: Week 12 (n=3, 7)	0.7 ± 0.58	0.4 ± 0.53
Short of B or H score: Week 0 (n=43, 44)	27.9 ± 16.98	28.6 ± 17.47
Short of B or H score: Week 4 (n=21, 24)	26.7 ± 13.17	27.5 ± 14.22
Short of B or H score: Week 8 (n=13, 15)	27.7 ± 15.36	33.3 ± 19.52
Short of B or H score: Week 12 (n=3, 7)	20.0 ± 0.00	22.9 ± 7.56
Snoring Score: Week 0 (n=43, 44)	43.3 ± 28.26	37.7 ± 24.86
Snoring Score: Week 4 (n=21, 24)	45.7 ± 28.39	39.2 ± 27.96
Snoring Score: Week 8 (n=13, 15)	44.6 ± 24.70	38.7 ± 23.26
Snoring Score: Week 12 (n=3, 7)	53.3 ± 23.09	34.3 ± 19.02
Sleep Disturbance Score: Week 0 (n=43, 44)	41.0 ± 19.08	40.9 ± 19.39
Sleep Disturbance Score: Week 4 (n=21, 24)	38.3 ± 18.36	38.6 ± 18.61
Sleep Disturbance Score: Week 8 (n=13, 15)	33.6 ± 12.81	41.4 ± 16.77
Sleep Disturbance Score: Week 12 (n=3, 7)	43.3 ± 16.65	43.6 ± 13.02
Sleep Adequacy Score: Week 0 (n=43, 44)	67.0 ± 20.99	66.1 ± 20.71
Sleep Adequacy Score: Week 4 (n=21, 24)	71.0 ± 23.00	67.1 ± 24.22
Sleep Adequacy Score: Week 8 (n=13, 15)	70.0 ± 22.36	66.0 ± 19.20
Sleep Adequacy Score: Week 12 (n=3, 7)	76.7 ± 15.28	64.3 ± 17.18
Sleep Somnolence Score: Week 0 (n=43, 44)	44.8 ± 20.74	45.9 ± 19.30
Sleep Somnolence Score: Week 4 (n=21, 24)	42.9 ± 22.76	48.3 ± 19.49
Sleep Somnolence Score: Week 8 (n=13, 15)	45.6 ± 22.91	54.2 ± 19.17
Sleep Somnolence Score: Week 12 (n=3, 7)	33.3 ± 13.33	50.5 ± 19.57
Sleep Problems Index I Score: Week 0 (n=43, 44)	36.3 ± 13.53	37.3 ± 15.29
Sleep Problems Index I Score: Week 4 (n=21, 24)	32.9 ± 16.27	36.7 ± 16.33
Sleep Problems Index I Score: Week 8 (n=13, 15)	32.8 ± 9.51	38.9 ± 13.07
Sleep Problems Index I Score: Week 12 (n=3, 7)	31.1 ± 11.71	39.0 ± 5.35
Sleep Problems Index II Score: Baseline (n=43, 44)	38.4 ± 14.19	38.6 ± 15.55
Sleep Problems Index II Score: Week 4 (n=21, 24)	35.8 ± 16.81	38.0 ± 16.06
Sleep Problems Index II Score: Week 8 (n=13, 15)	34.6 ± 10.26	41.4 ± 13.30
Sleep Problems Index II Score: Week 12 (n=3, 7)	34.1 ± 12.97	40.3 ± 6.13

No statistical analyses for this end point

Secondary: Medical Outcomes Study Sleep Scale Score: First Flare Free Period

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End point title

Medical Outcomes Study Sleep Scale Score: First Flare Free Period

End point description

End point type

Secondary

End point timeframe

Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	69	78
Units: Units on a scale
arithmetic mean (standard deviation)
Quantity Hours Slept Score: Baseline (n=69, 78)	8.3 ± 3.79	7.5 ± 2.42
Quantity Hours Slept Score: Week 4 (n=29, 51)	9.0 ± 4.68	8.1 ± 3.32
Quantity Hours Slept Score: Week 8 (n=25, 44)	8.5 ± 3.77	7.9 ± 3.92
Quantity Hours Slept Score: Week 12 (n=20, 40)	8.6 ± 4.15	7.6 ± 3.22
Quantity Hours Slept Score: Week 16 (n=19, 37)	8.5 ± 4.11	8.5 ± 4.90
Quantity Hours Slept Score: Week 20 (n=8, 13)	7.0 ± 1.20	7.7 ± 1.55
Quantity Hours Slept Score: Week 24 (n=17, 31)	7.2 ± 1.99	7.4 ± 3.45
Quantity Hours Slept Score: Week 28 (n=7, 9)	6.9 ± 1.07	7.4 ± 1.51
Quantity Hours Slept Score: Week 32 (n=16, 27)	8.5 ± 4.24	7.6 ± 1.22
Quantity Hours Slept Score: Week 36 (n=6, 7)	7.0 ± 0.89	8.0 ± 1.41
Quantity Hours Slept Score: Week 40 (n=17, 26)	8.3 ± 4.57	7.5 ± 2.97
Quantity Hours Slept Score: Week 44 (n=7, 9)	6.7 ± 1.11	7.1 ± 0.60
Quantity Hours Slept Score: Week 48 (n=17, 24)	7.2 ± 1.63	7.2 ± 1.46
Quantity Hours Slept Score: Week 52 (n=15, 23)	8.0 ± 4.57	7.0 ± 1.24
Optimal Hours Slept Score: Baseline (n=69, 78)	0.5 ± 0.50	0.6 ± 0.50
Optimal Hours Slept Score: Week 4 (n=29, 51)	0.6 ± 0.50	0.6 ± 0.50
Optimal Hours Slept Score: Week 8 (n=25, 44)	0.7 ± 0.46	0.6 ± 0.49
Optimal Hours Slept Score: Week 12 (n=20, 40)	0.4 ± 0.50	0.6 ± 0.50
Optimal Hours Slept Score: Week 16 (n=19, 37)	0.5 ± 0.51	0.6 ± 0.50
Optimal Hours Slept Score: Week 20 (n=8, 13)	0.6 ± 0.52	0.5 ± 0.52
Optimal Hours Slept Score: Week 24 (n=17, 31)	0.5 ± 0.51	0.6 ± 0.50
Optimal Hours Slept Score: Week 28 (n=7, 9)	0.7 ± 0.49	0.6 ± 0.53
Optimal Hours Slept Score: Week 32 (n=16, 27)	0.6 ± 0.50	0.7 ± 0.45
Optimal Hours Slept Score: Week 36 (n=6, 7)	0.7 ± 0.52	0.9 ± 0.38
Optimal Hours Slept Score: Week 40 (n=17, 26)	0.5 ± 0.51	0.5 ± 0.51
Optimal Hours Slept Score: Week 44 (n=7, 9)	0.6 ± 0.53	0.9 ± 0.33
Optimal Hours Slept Score: Week 48 (n=17, 24)	0.6 ± 0.51	0.4 ± 0.50
Optimal Hours Slept Score: Week 52 (n=15, 23)	0.4 ± 0.51	0.5 ± 0.51
Short of B or H score: Baseline (n=69, 78)	24.1 ± 9.44	27.2 ± 15.45
Short of B or H score:Week 4 (n=30, 51)	24.0 ± 12.21	23.9 ± 9.81
Short of B or H score: Week 8 (n=25, 44)	24.8 ± 10.46	23.6 ± 9.90
Short of B or H score: Week 12 (n=20, 40)	23.0 ± 7.33	26.0 ± 12.97
Short of B or H score: Week 16 (n=19, 37)	24.2 ± 8.38	24.9 ± 10.96
Short of B or H score: Week 20 (n=8, 13)	22.5 ± 7.07	29.2 ± 17.54
Short of B or H score: Week 24 (n=17, 31)	24.7 ± 11.25	26.5 ± 11.99
Short of B or H score: Week 28 (n=7, 9)	31.4 ± 22.68	26.7 ± 14.14
Short of B or H score: Week 32 (n=16, 27)	25.0 ± 8.94	22.2 ± 8.47
Short of B or H score: Week 36 (n=6, 7)	20.0 ± 0.00	20.0 ± 0.00
Short of B or H score: Week 40 (n=17, 26)	22.4 ± 6.64	25.4 ± 12.08
Short of B or H score: Week 44 (n=7, 9)	22.9 ± 7.56	28.9 ± 14.53
Short of B or H score: Week 48 (n=17, 24)	22.4 ± 6.64	25.0 ± 12.16
Short of B or H score: Week 52 (n=15, 23)	22.7 ± 7.04	27.8 ± 11.66
Snoring Score: Baseline (n=69, 78)	42.9 ± 26.41	37.2 ± 23.40
Snoring Score: Week 4 (n=30, 51)	47.3 ± 27.53	36.5 ± 21.43
Snoring Score: Week 8 (n=25, 44)	49.6 ± 26.53	35.5 ± 22.77
Snoring Score: Week 12 (n=20, 40)	49.0 ± 28.64	33.5 ± 20.95
Snoring Score: Week 16 (n=19, 37)	45.3 ± 27.36	34.6 ± 19.80
Snoring Score: Week 20 (n=8, 13)	42.5 ± 27.12	23.1 ± 7.51
Snoring Score: Week 24 (n=17, 31)	54.1 ± 26.23	38.1 ± 22.72
Snoring Score: Week 28 (n=7, 9)	48.6 ± 30.24	22.2 ± 6.67
Snoring Score: Week 32 (n=16, 27)	40.0 ± 19.32	37.8 ± 21.72
Snoring Score: Week 36 (n=6, 7)	36.7 ± 15.06	25.7 ± 9.76
Snoring Score: Week 40 (n=17, 26)	44.7 ± 26.01	38.5 ± 21.85
Snoring Score: Week 44 (n=7, 9)	28.6 ± 10.69	28.9 ± 14.53
Snoring Score: Week 48 (n=17, 24)	44.7 ± 16.63	40.0 ± 24.32
Snoring Score: Week 52 (n=15, 23)	46.7 ± 20.93	41.7 ± 21.67
Sleep Disturbance Score: Baseline (n=69, 78)	38.3 ± 18.74	34.8 ± 17.51
Sleep Disturbance Score: Week 4 (n=30, 51)	34.3 ± 15.11	32.2 ± 14.92
Sleep Disturbance Score: Week 8 (n=25, 44)	31.7 ± 12.00	35.1 ± 16.27
Sleep Disturbance Score: Week 12 (n=20, 40)	33.3 ± 14.51	32.3 ± 17.12
Sleep Disturbance Score: Week 16 (n=19, 37)	35.9 ± 17.17	30.6 ± 14.57
Sleep Disturbance Score: Week 20 (n=8, 13)	32.8 ± 12.22	28.0 ± 9.31
Sleep Disturbance Score: Week 24 (n=17, 31)	30.7 ± 15.90	35.9 ± 18.34
Sleep Disturbance Score: Week 28 (n=7, 9)	37.3 ± 11.78	31.1 ± 12.43
Sleep Disturbance Score: Week 32 (n=16, 27)	31.4 ± 14.75	32.3 ± 12.28
Sleep Disturbance Score: Week 36 (n=6, 7)	27.7 ± 9.43	27.7 ± 10.93
Sleep Disturbance Score: Week 40 (n=17, 26)	34.3 ± 14.80	33.2 ± 18.06
Sleep Disturbance Score: Week 44 (n=7, 9)	23.9 ± 10.47	34.3 ± 16.25
Sleep Disturbance Score: Week 48 (n=17, 24)	33.9 ± 11.81	30.2 ± 16.76
Sleep Disturbance Score: Week 52 (n=15, 23)	32.4 ± 16.27	31.6 ± 15.29
Sleep Adequacy Score: Baseline (n=69, 78)	68.6 ± 18.25	69.1 ± 21.69
Sleep Adequacy Score: Week 4 (n=30, 51)	71.0 ± 20.74	71.6 ± 18.80
Sleep Adequacy Score: Week 8 (n=25, 44)	72.8 ± 17.20	73.2 ± 21.43
Sleep Adequacy Score: Week 12 (n=20, 40)	75.0 ± 20.90	68.0 ± 21.74
Sleep Adequacy Score: Week 16 (n=19, 37)	74.7 ± 20.65	66.5 ± 17.98
Sleep Adequacy Score: Week 20 (n=8, 13)	70.0 ± 22.68	66.9 ± 21.36
Sleep Adequacy Score: Week 24 (n=17, 31)	76.5 ± 16.18	68.1 ± 20.88
Sleep Adequacy Score: Week 28 (n=7, 9)	70.0 ± 19.15	72.2 ± 28.19
Sleep Adequacy Score: Week 32 (n=16, 27)	78.8 ± 14.55	74.4 ± 19.87
Sleep Adequacy Score: Week 36 (n=6, 7)	75.0 ± 15.17	72.9 ± 17.99
Sleep Adequacy Score: Week 40 (n=17, 26)	72.9 ± 16.11	68.1 ± 18.33
Sleep Adequacy Score: Week 44 (n=7, 9)	67.1 ± 26.28	73.3 ± 26.46
Sleep Adequacy Score: Week 48 (n=17, 24)	75.3 ± 14.63	72.9 ± 18.99
Sleep Adequacy Score: Week 52 (n=15, 23)	74.7 ± 13.56	67.8 ± 23.35
Sleep Somnolence Score: Baseline (n=69, 78)	40.3 ± 17.05	41.8 ± 18.51
Sleep Somnolence Score: Week 4 (n=30, 51)	40.0 ± 15.56	42.4 ± 18.13
Sleep Somnolence Score: Week 8 (n=25, 44)	36.3 ± 10.55	39.1 ± 18.89
Sleep Somnolence Score: Week 12 (n=20, 40)	38.0 ± 14.03	41.3 ± 18.81
Sleep Somnolence Score: Week 16 (n=19, 37)	34.4 ± 10.00	40.5 ± 17.38
Sleep Somnolence Score: Week 20 (n=8, 13)	42.5 ± 24.67	36.9 ± 20.66
Sleep Somnolence Score: Week 24 (n=17, 31)	39.6 ± 16.07	42.8 ± 19.98
Sleep Somnolence Score: Week 28 (n=7, 9)	48.6 ± 24.26	37.0 ± 20.03
Sleep Somnolence Score: Week 32 (n=16, 27)	44.6 ± 20.76	42.5 ± 15.04
Sleep Somnolence Score: Week 36 (n=6, 7)	35.6 ± 19.63	31.4 ± 9.20
Sleep Somnolence Score: Week 40 (n=17, 26)	36.1 ± 16.51	43.1 ± 15.35
Sleep Somnolence Score: Week 44 (n=7, 9)	37.1 ± 16.71	40.7 ± 18.99
Sleep Somnolence Score: Week 48 (n=17, 24)	39.6 ± 14.62	43.1 ± 13.04
Sleep Somnolence Score: Week 52 (n=15, 23)	38.7 ± 13.14	39.1 ± 14.11
Sleep Problems Index I Score: Baseline (n=69, 78)	33.4 ± 12.63	33.2 ± 14.19
Sleep Problems Index I Score: Week 4 (n=30, 51)	31.4 ± 13.64	31.6 ± 11.53
Sleep Problems Index I Score: Week 8 (n=25, 44)	28.9 ± 10.79	30.7 ± 13.99
Sleep Problems Index I Score: Week 12 (n=20, 40)	29.3 ± 13.27	33.2 ± 13.22
Sleep Problems Index I Score: Week 16 (n=19, 37)	30.2 ± 11.78	32.6 ± 12.10
Sleep Problems Index I Score: Week 20 (n=8, 13)	32.5 ± 12.05	31.8 ± 14.12
Sleep Problems Index I Score: Week 24 (n=17, 31)	28.0 ± 12.25	34.4 ± 14.87
Sleep Problems Index I Score: Week 28 (n=7, 9)	35.7 ± 13.97	28.5 ± 13.34
Sleep Problems Index I Score: Week 32 (n=16, 27)	29.2 ± 8.39	30.5 ± 12.63
Sleep Problems Index I Score: Week 36 (n=6, 7)	28.3 ± 9.83	26.2 ± 11.45
Sleep Problems Index I Score: Week 40 (n=17, 26)	30.8 ± 11.15	34.4 ± 14.78
Sleep Problems Index I Score: Week 44 (n=7, 9)	29.5 ± 11.93	30.7 ± 14.32
Sleep Problems Index I Score: Week 48 (n=17, 24)	31.6 ± 10.74	31.0 ± 12.83
Sleep Problems Index I Score: Week 52 (n=15, 23)	30.2 ± 9.13	32.0 ± 13.62
Sleep Problems Index II Score: Baseline (n=69, 78)	35.5 ± 13.20	34.4 ± 14.17
Sleep Problems Index II Score: Week 4 (n=30, 51)	32.8 ± 12.00	32.1 ± 11.57
Sleep Problems Index II Score: Week 8 (n=25, 44)	30.3 ± 10.27	32.4 ± 13.36
Sleep Problems Index II Score: Week 12 (n=20, 40)	30.5 ± 12.70	32.8 ± 13.47
Sleep Problems Index II Score: Week 16 (n=19, 37)	31.2 ± 12.90	32.7 ± 11.83
Sleep Problems Index II Score: Week 20 (n=8, 13)	33.2 ± 12.21	31.1 ± 11.85
Sleep Problems Index II Score: Week 24 (n=17, 31)	29.6 ± 11.67	35.4 ± 14.29
Sleep Problems Index II Score: Week 28 (n=7, 9)	36.9 ± 12.41	30.9 ± 11.08
Sleep Problems Index II Score: Week 32 (n=16, 27)	30.9 ± 8.47	31.5 ± 11.36
Sleep Problems Index II Score: Week 36 (n=6, 7)	27.9 ± 8.99	27.5 ± 8.80
Sleep Problems Index II Score: Week 40 (n=17, 26)	31.3 ± 10.00	34.3 ± 14.03
Sleep Problems Index II Score: Week 44 (n=7, 9)	28.1 ± 9.82	33.8 ± 14.04
Sleep Problems Index II Score: Week 48 (n=17, 24)	31.4 ± 9.57	31.6 ± 12.65
Sleep Problems Index II Score: Week 52 (n=15, 23)	30.6 ± 8.85	32.4 ± 12.20

No statistical analyses for this end point

Secondary: European Quality of Life-5 Dimension 5-Level (EuroQoL EQ-5D-5L) Index Score in Subjects Greater Than or Equal to (>=) 18 Years of age: OL Run-in Period

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End point title

European Quality of Life-5 Dimension 5-Level (EuroQoL EQ-5D-5L) Index Score in Subjects Greater Than or Equal to (>=) 18 Years of age: OL Run-in Period

End point description

EQ-5D-5L:subject rated questionnaire consist of 6 questions used to calculate health utility score.Two components to EQ-5D-5L: 5-item health state profile assessed 5 dimensions:mobility,self-care,usual activities,pain/discomfort,anxiety/depression used to obtain Index Utility Score, VAS measures health state. Each dimension:5 levels:1=no problems,2= slight,3= moderate,4= severe,5= extreme. Responses to 5 dimensions comprised health state/a single utility index value.Eg.If subject responded"no problems"for each 5 dimensions,then health state coded:"11111" with predefined index value to it.Health state(coded as combination of responses on 5 dimensions)had unique predefined utility index value assigned to it,by EuroQol. US value sets(with all possible health states)was used for adults in the study,range from1 to-0.109. Higher(positive)scores= better health state.Eval-OL analysed.‘N’:number of subjects evaluable for this end point,‘n’:number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8

End point values	Crisaborole 2% BID
Number of subjects analysed	169
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n=166)	0.9 ± 0.12
Week 2 (n=168)	0.9 ± 0.13
Week 4 (n=169)	0.9 ± 0.11
Week 6 (n=169)	0.9 ± 0.12
Week 8 (n=169)	0.9 ± 0.11

No statistical analyses for this end point

Secondary: European Quality of Life-5 Dimension Youth (EuroQoL EQ-5D Y) Index Score in Subjects Between 8-17 Years of age: OL Run-in Period

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End point title

European Quality of Life-5 Dimension Youth (EuroQoL EQ-5D Y) Index Score in Subjects Between 8-17 Years of age: OL Run-in Period

End point description

EQ-5D-Y: child-friendly version of EQ-5D questionnaire related to health status. Health state profile assessed health in 5 dimensions (Mobility; Looking After Myself; Doing Usual Activities; Having Pain or Discomfort; Feeling Worried, Sad or Unhappy) used to obtain an index score, each of which had three levels of response (no problems/no pain/not worried, some problems/some pain/a bit worried, a lot of problems/a lot of pain/very worried). Scores ranged from <0 (where 0 is the value of a health state equivalent to dead; negative values: values as worse than dead) to 1 (the value of full health), higher scores=higher health utility. Eval-OL population included all subjects that received at least 1 dose of study intervention in the OL period. Here, ‘N’: number of subjects evaluable for this end point and ‘n’: number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8

End point values	Crisaborole 2% BID
Number of subjects analysed	169
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n=164)	0.9 ± 0.13
Week 2 (n=168)	0.9 ± 0.11
Week 4 (n=169)	0.9 ± 0.12
Week 6 (n=169)	0.9 ± 0.11
Week 8 (n=169)	0.9 ± 0.15

No statistical analyses for this end point

Secondary: EuroQoL EQ-5D Y Proxy Index Scores in Subjects Between 2-7 Years of age: OL Run-in Period

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End point title

EuroQoL EQ-5D Y Proxy Index Scores in Subjects Between 2-7 Years of age: OL Run-in Period

End point description

EQ-5D-Y: child-friendly version of EQ-5D questionnaire related to health status. Health state profile assessed health in 5 dimensions (Mobility; Looking After Myself; Doing Usual Activities; Having Pain or Discomfort; Feeling Worried, Sad or Unhappy) used to obtain an index score, each of which had three levels of response (no problems/no pain/not worried, some problems/some pain/a bit worried, a lot of problems/a lot of pain/very worried). Scores ranged from <0 (where 0 is the value of a health state equivalent to dead; negative values: values as worse than dead) to 1 (the value of full health), higher scores=higher health utility. Proxy version was filled by care-giver of the subject. Eval-OL population included all subjects that received at least 1 dose of study intervention in the OL period. Here, ‘N’: number of subjects evaluable for this end point.

End point type

Secondary

End point timeframe

Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8

End point values	Crisaborole 2% BID
Number of subjects analysed	136
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline	0.8 ± 0.17
Week 2	0.9 ± 0.16
Week 4	0.9 ± 0.17
Week 6	0.9 ± 0.17
Week 8	0.9 ± 0.18

No statistical analyses for this end point

Secondary: EuroQoL EQ-5D-5L Visual Analog Scale (VAS) Score in Subjects >= 18 Years of age: OL Run-in Period

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End point title

EuroQoL EQ-5D-5L Visual Analog Scale (VAS) Score in Subjects >= 18 Years of age: OL Run-in Period

End point description

The EQ-5D-5L is a participant rated questionnaire that consisted of six questions used to calculate a health utility score. There were two components to the EQ-5D-5L: a five-item health state profile that assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression used to obtain an Index Utility Score, as well as a VAS that measures health state. EQ-5D VAS was used to record subject’s rating for his/her current health-related quality of life state on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state. Eval-OL population included all subjects that received at least 1 dose of study intervention in the OL period. Here, ‘N’: number of subjects evaluable for this end point and ‘n’: number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8

End point values	Crisaborole 2% BID
Number of subjects analysed	169
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n=166)	81.2 ± 15.81
Week 2 (n=168)	82.2 ± 16.14
Week 4 (n=169)	82.0 ± 15.73
Week 6 (n=169)	84.0 ± 14.89
Week 8 (n=169)	84.2 ± 14.18

No statistical analyses for this end point

Secondary: EuroQoL EQ-5D Y VAS Scores in Subjects Between 8-17 Years of age : OL-Run-in Period

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End point title

EuroQoL EQ-5D Y VAS Scores in Subjects Between 8-17 Years of age : OL-Run-in Period

End point description

The EQ-5D-Y: child-friendly version of EQ-5D questionnaire related to health status. Comprised of two components: a five-item health state profile that assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression used to obtain an Index Utility Score, as well as a VAS on which the respondent rated his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health). Eval-OL population included all subjects that received at least 1 dose of study intervention in the OL period. Here, ‘N’: number of subjects evaluable for this end point and ‘n’: number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8

End point values	Crisaborole 2% BID
Number of subjects analysed	169
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n=164)	85.6 ± 16.27
Week 2 (n=168)	87.4 ± 11.91
Week 4 (n=169)	87.5 ± 12.92
Week 6 (n=169)	87.9 ± 12.72
Week 8 (n=169)	88.0 ± 12.93

No statistical analyses for this end point

Secondary: EuroQoL EQ-5D Y Proxy VAS Scores in Subjects Between 2-7 Years of age: OL Run-in Period

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End point title

EuroQoL EQ-5D Y Proxy VAS Scores in Subjects Between 2-7 Years of age: OL Run-in Period

End point description

EQ-5D-Y: child-friendly version of EQ-5D questionnaire related to health status. Health state profile assessed health in 5 dimensions (Mobility; Looking After Myself; Doing Usual Activities; Having Pain or Discomfort; Feeling Worried, Sad or Unhappy) used to obtain an index score, each of which had three levels of response (no problems/no pain/not worried, some problems/some pain/a bit worried, a lot of problems/a lot of pain/very worried). Scores ranged from <0 (where 0 is the value of a health state equivalent to dead; negative values: values as worse than dead) to 1 (the value of full health), higher scores=higher health utility. Proxy version was filled by care-giver of the subject. Eval-OL population included all subjects that received at least 1 dose of study intervention in the OL period. Here, ‘N’: number of subjects evaluable for this end point.

End point type

Secondary

End point timeframe

Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8

End point values	Crisaborole 2% BID
Number of subjects analysed	136
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline	86.0 ± 13.97
Week 2	87.6 ± 12.61
Week 4	90.0 ± 11.05
Week 6	90.4 ± 11.45
Week 8	90.8 ± 11.63

No statistical analyses for this end point

Secondary: EuroQoL EQ-5D-5L Index Scores in Subjects >= 18 Years of age: DB Period

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End point title

EuroQoL EQ-5D-5L Index Scores in Subjects >= 18 Years of age: DB Period

End point description

EQ-5D-5L:subject rated questionnaire, 6 questions to calculate health utility score. 2 components to EQ-5D-5L: 5-item health state profile assessed 5 dimensions:mobility,self-care,usual activities,pain/discomfort and anxiety/depression used to obtain Index Utility Score,VAS that measures health state. Each dimension:5 levels:1=no problems,2=slight,3=moderate,4=severe,5=extreme.Response to 5 dimensions comprised health state/a single utility index value.Eg. if subject responded"no problems"for each 5 dimensions, health state coded:"11111" with predefined index value to it.Every health state(coded as combination of responses on each of 5 dimensions):unique predefined utility index value assigned to it by EuroQol. US value sets(with all possible health states)used for adults in the study,range from 1 to -0.109. Higher(positive) scores= better health state. Eval-DB population analysed.‘N’:number of subjects evaluable for end point,‘n’:number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline (the last observation up to and including Day 1 of OL period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	46	48
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n=46, 48)	0.9 ± 0.09	0.9 ± 0.11
Week 4 (n=23, 30)	0.9 ± 0.12	0.9 ± 0.10
Week 8 (n=25, 31)	0.9 ± 0.09	0.9 ± 0.10
Week 12 (n=23, 28)	0.9 ± 0.10	0.9 ± 0.18
Week 16 (n=31, 33)	0.9 ± 0.11	0.9 ± 0.15
Week 20 (n=15, 13)	0.9 ± 0.12	0.9 ± 0.15
Week 24 (n=26, 30)	0.9 ± 0.10	0.9 ± 0.21
Week 28 (n=12, 11)	0.9 ± 0.18	0.9 ± 0.14
Week 32 (n=23, 27)	0.9 ± 0.11	0.8 ± 0.22
Week 36 (n=11, 11)	0.9 ± 0.09	0.9 ± 0.13
Week 40 (n=23, 28)	0.9 ± 0.10	0.8 ± 0.24
Week 44 (n=12, 11)	0.9 ± 0.18	0.9 ± 0.14
Week 48 (n=22, 24)	0.9 ± 0.11	0.8 ± 0.23
Week 52 (n=25, 23)	0.9 ± 0.10	0.8 ± 0.24

No statistical analyses for this end point

Secondary: EuroQoL EQ-5D Y Index Scores in Subjects Between 8-17 Years of age: DB Period

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End point title

EuroQoL EQ-5D Y Index Scores in Subjects Between 8-17 Years of age: DB Period

End point description

The EQ-5D-Y: child-friendly version of EQ-5D questionnaire related to health status. Comprised of two components: a five-item health state profile that assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression used to obtain an Index Utility Score, as well as a VAS on which the respondent rated his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health). Eval-DB population included all randomised subjects with success in ISGA and EASI50 criteria as responders at randomisation and received at least 1 dose of study intervention in the DB period. Here, ‘N’: number of subjects evaluable for this end point and ‘n’: number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline (the last observation up to and including Day 1 of OL period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	38	43
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n=38, 43)	0.9 ± 0.08	0.9 ± 0.18
Week 4 (n=15, 28)	1.0 ± 0.07	1.0 ± 0.07
Week 8 (n=18, 27)	1.0 ± 0.07	1.0 ± 0.08
Week 12 (n=19, 28)	1.0 ± 0.06	1.0 ± 0.07
Week 16 (n=21, 28)	1.0 ± 0.08	1.0 ± 0.07
Week 20 (n=9, 13)	0.9 ± 0.09	1.0 ± 0.05
Week 24 (n=19, 28)	1.0 ± 0.07	1.0 ± 0.06
Week 28 (n=10, 14)	0.9 ± 0.09	0.9 ± 0.08
Week 32 (n=20, 28)	1.0 ± 0.06	1.0 ± 0.06
Week 36 (n=10, 11)	1.0 ± 0.08	1.0 ± 0.08
Week 40 (n=17, 24)	1.0 ± 0.07	0.9 ± 0.13
Week 44 (n=10, 11)	1.0 ± 0.08	0.9 ± 0.22
Week 48 (n=15, 26)	1.0 ± 0.07	0.9 ± 0.09
Week 52 (n=18, 25)	1.0 ± 0.07	1.0 ± 0.07

No statistical analyses for this end point

Secondary: EuroQoL EQ-5D Y Proxy Index Scores in Subjects Between 2-7 Years of age: DB Period

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End point title

EuroQoL EQ-5D Y Proxy Index Scores in Subjects Between 2-7 Years of age: DB Period

End point description

EQ-5D-Y: child-friendly version of EQ-5D questionnaire related to health status. Health state profile assessed health in 5 dimensions (Mobility; Looking After Myself; Doing Usual Activities; Having Pain or Discomfort; Feeling Worried, Sad or Unhappy) used to obtain an index score, each of which had three levels of response (no problems/no pain/not worried, some problems/some pain/a bit worried, a lot of problems/a lot of pain/very worried). Scores ranged from <0 (where 0 is the value of a health state equivalent to dead; negative values: values as worse than dead) to 1 (the value of full health), higher scores=higher health utility. Proxy version was filled by care-giver of the subject. Eval-DB population was analysed. Here, ‘N’: number of subjects evaluable for this end point and ‘n’: number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	41	30
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n=41, 30)	1.0 ± 0.08	0.9 ± 0.12
Week 4 (n=17, 14)	0.9 ± 0.09	0.9 ± 0.14
Week 8 (n=22, 14)	0.9 ± 0.09	0.9 ± 0.09
Week 12 (n=18, 17)	1.0 ± 0.07	0.9 ± 0.13
Week 16 (n=16, 17)	1.0 ± 0.09	1.0 ± 0.07
Week 20 (n=13, 10)	0.9 ± 0.10	0.9 ± 0.15
Week 24 (n=20, 15)	1.0 ± 0.08	1.0 ± 0.07
Week 28 (n=13, 9)	0.9 ± 0.09	0.9 ± 0.09
Week 32 (n=17, 11)	1.0 ± 0.06	1.0 ± 0.07
Week 36 (n=10, 8)	1.0 ± 0.05	0.9 ± 0.10
Week 40 (n=15, 9)	0.9 ± 0.09	0.9 ± 0.08
Week 44 (n=10, 6)	1.0 ± 0.07	0.9 ± 0.10
Week 48 (n=16, 12)	1.0 ± 0.07	1.0 ± 0.07
Week 52 (n=19, 13)	1.0 ± 0.05	1.0 ± 0.00

No statistical analyses for this end point

Secondary: EuroQoL EQ-5D-5L VAS Scores in Subjects >= 18 Years of age: DB Period

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End point title

EuroQoL EQ-5D-5L VAS Scores in Subjects >= 18 Years of age: DB Period

End point description

The EQ-5D-5L is a participant rated questionnaire that consisted of six questions used to calculate a health utility score. There were two components to the EQ-5D-5L: a five-item health state profile that assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression used to obtain an Index Utility Score, as well as a VAS that measures health state. EQ-5D VAS was used to record subject’s rating for his/her current health-related quality of life state on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state. Eval-DB population analysed. Here ‘N’:number of subjects evaluable for end point,‘n’:number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	46	48
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n=46, 48)	88.3 ± 9.41	85.2 ± 15.56
Week 4 (n=23, 30)	89.9 ± 9.00	86.8 ± 10.74
Week 8 (n=25, 31)	90.7 ± 7.76	87.3 ± 12.02
Week 12 (n=23, 28)	88.5 ± 13.72	80.5 ± 21.68
Week 16 (n=31, 33)	88.1 ± 11.86	82.7 ± 18.94
Week 20 (n=15, 13)	87.1 ± 13.77	82.7 ± 14.47
Week 24 (n=26, 30)	89.2 ± 10.98	83.1 ± 19.39
Week 28 (n=12, 11)	88.3 ± 9.29	83.7 ± 16.57
Week 32 (n=23, 27)	90.0 ± 8.91	83.0 ± 20.02
Week 36 (n=11, 11)	90.8 ± 8.68	83.4 ± 12.80
Week 40 (n=23, 28)	88.9 ± 12.99	82.4 ± 20.68
Week 44 (n=12, 11)	87.2 ± 13.64	81.9 ± 13.96
Week 48 (n=22, 24)	88.8 ± 12.90	85.1 ± 20.92
Week 52 (n=25, 23)	90.0 ± 11.44	82.7 ± 20.98

No statistical analyses for this end point

Secondary: EuroQoL EQ-5D Y VAS Scores in Subjects Between 8-17 Years of age: DB Period

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End point title

EuroQoL EQ-5D Y VAS Scores in Subjects Between 8-17 Years of age: DB Period

End point description

EQ-5D-Y: child-friendly version of EQ-5D questionnaire related to health status. Health state profile assessed health in 5 dimensions (Mobility; Looking After Myself; Doing Usual Activities; Having Pain or Discomfort; Feeling Worried, Sad or Unhappy) used to obtain an index score, each of which had three levels of response (no problems/no pain/not worried, some problems/some pain/a bit worried, a lot of problems/a lot of pain/very worried). Scores ranged from <0 (where 0 is the value of a health state equivalent to dead; negative values: values as worse than dead) to 1 (the value of full health), higher scores=higher health utility. Eval-DB population was analysed. Here, ‘N’: number of subjects evaluable for this end point and ‘n’: number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline (the last observation up to and including Day 1 of OL period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	38	43
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n=38, 43)	86.8 ± 14.86	91.1 ± 9.34
Week 4 (n=15, 28)	88.3 ± 11.29	91.6 ± 7.27
Week 8 (n=18, 27)	89.6 ± 9.52	88.6 ± 14.34
Week 12 (n=19, 28)	91.9 ± 9.18	89.1 ± 13.36
Week 16 (n=21, 28)	91.3 ± 8.20	88.9 ± 13.91
Week 20 (n=9, 13)	85.1 ± 10.89	87.8 ± 21.65
Week 24 (n=19, 28)	91.7 ± 10.92	89.3 ± 12.83
Week 28 (n=10, 14)	89.9 ± 12.09	90.4 ± 13.36
Week 32 (n=20, 28)	91.1 ± 9.40	91.5 ± 12.98
Week 36 (n=10, 11)	90.7 ± 10.34	91.7 ± 14.86
Week 40 (n=17, 24)	92.2 ± 9.03	89.8 ± 13.25
Week 44 (n=10, 11)	93.5 ± 8.70	88.3 ± 15.81
Week 48 (n=15, 26)	92.1 ± 9.75	91.3 ± 13.64
Week 52 (n=18, 25)	90.9 ± 13.75	92.6 ± 11.27

No statistical analyses for this end point

Secondary: EuroQoL EQ-5D Y Proxy VAS Scores in Subjects Between 2-7 Years of age: DB Period

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End point title

EuroQoL EQ-5D Y Proxy VAS Scores in Subjects Between 2-7 Years of age: DB Period

End point description

EQ-5D-Y: child-friendly version of EQ-5D questionnaire related to health status. Health state profile assessed health in 5 dimensions (Mobility; Looking After Myself; Doing Usual Activities; Having Pain or Discomfort; Feeling Worried, Sad or Unhappy) used to obtain an index score, each of which had three levels of response (no problems/no pain/not worried, some problems/some pain/a bit worried, a lot of problems/a lot of pain/very worried). Scores ranged from <0 (where 0 is the value of a health state equivalent to dead; negative values: values as worse than dead) to 1 (the value of full health), higher scores=higher health utility. Proxy version was filled by care-giver of the subject. Eval-DB population was analysed. Here, ‘N’: number of subjects evaluable for this end point and ‘n’: number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline (the last observation up to and including Day 1 of DB period),Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	41	30
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n=41, 30)	93.8 ± 9.97	94.3 ± 8.16
Week 4 (n=17, 14)	94.6 ± 5.86	96.3 ± 6.54
Week 8 (n=22, 14)	93.0 ± 7.39	96.3 ± 6.17
Week 12 (n=18, 17)	95.2 ± 5.47	96.8 ± 3.73
Week 16 (n=16, 17)	92.9 ± 7.08	96.5 ± 2.81
Week 20 (n=13, 10)	94.9 ± 5.09	93.4 ± 6.50
Week 24 (n=20, 15)	95.1 ± 5.62	95.7 ± 4.62
Week 28 (n=13, 9)	95.8 ± 5.60	97.1 ± 4.17
Week 32 (n=17, 11)	95.5 ± 5.70	96.9 ± 2.12
Week 36 (n=10, 8)	97.4 ± 2.99	97.8 ± 2.49
Week 40 (n=15, 9)	93.7 ± 7.76	96.8 ± 3.46
Week 44 (n=10, 6)	96.6 ± 4.60	97.8 ± 2.71
Week 48 (n=16, 12)	96.1 ± 5.15	96.9 ± 4.01
Week 52 (n=19, 13)	95.0 ± 5.51	96.7 ± 3.97

No statistical analyses for this end point

Secondary: EuroQoL EQ-5D-5L Index Scores in Subjects >= 18 Years of age: First Flare Period

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End point title

EuroQoL EQ-5D-5L Index Scores in Subjects >= 18 Years of age: First Flare Period

End point description

The EQ-5D-5L is a participant rated questionnaire that consisted of six questions used to calculate a health utility score. There were two components to the EQ-5D-5L: a five-item health state profile that assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression used to obtain an Index Utility Score, as well as a VAS that measures health state. EQ-5D VAS was used to record subject’s rating for his/her current health-related quality of life state on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state. Eval-DB population analysed. Here ‘N’:number of subjects evaluable for end point,‘n’:number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Weeks 0, 4, 8 and 12

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	27	28
Units: Units on a scale
arithmetic mean (standard deviation)
Week 0 (n=27, 28)	0.9 ± 0.11	0.9 ± 0.15
Week 4 (n=14, 15)	1.0 ± 0.07	0.8 ± 0.19
Week 8 (n= 9, 10)	1.0 ± 0.06	0.8 ± 0.07
Week 12 (n=3, 3)	0.9 ± 0.10	0.9 ± 0.10

No statistical analyses for this end point

Secondary: EuroQoL EQ-5D Y Index Scores in Subjects Between 8-17 Years of age: First Flare Period

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End point title

EuroQoL EQ-5D Y Index Scores in Subjects Between 8-17 Years of age: First Flare Period

End point description

EQ-5D-Y: child-friendly version of EQ-5D questionnaire related to health status. Health state profile assessed health in 5 dimensions (Mobility; Looking After Myself; Doing Usual Activities; Having Pain or Discomfort; Feeling Worried, Sad or Unhappy) used to obtain an index score, each of which had three levels of response (no problems/no pain/not worried, some problems/some pain/a bit worried, a lot of problems/a lot of pain/very worried). Scores ranged from <0 (where 0 is the value of a health state equivalent to dead; negative values: values as worse than dead) to 1 (the value of full health), higher scores=higher health utility. Eval-DB population was analysed. Here, ‘N’: number of subjects evaluable for this end point and ‘n’: number of subjects evaluable at specific time points. 99999: data not available.

End point type

Secondary

End point timeframe

Weeks 0, 4, 8 and 12

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	28	22
Units: Units on a scale
arithmetic mean (standard deviation)
Week 0 (n=28, 22)	0.9 ± 0.09	0.8 ± 0.25
Week 4 (n=14, 13)	0.9 ± 0.09	0.9 ± 0.13
Week 8 (n=9, 9)	0.9 ± 0.10	0.9 ± 0.11
Week 12 (n=1, 5)	1.0 ± 99999	0.9 ± 0.09

No statistical analyses for this end point

Secondary: EuroQoL EQ-5D Y Proxy Index Scores in Subjects Between 2-7 Years of age: First Flare Period

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End point title

EuroQoL EQ-5D Y Proxy Index Scores in Subjects Between 2-7 Years of age: First Flare Period

End point description

EQ-5D-Y: child-friendly version of EQ-5D questionnaire related to health status. Health state profile assessed health in 5 dimensions (Mobility; Looking After Myself; Doing Usual Activities; Having Pain or Discomfort; Feeling Worried, Sad or Unhappy) used to obtain an index score, each of which had three levels of response (no problems/no pain/not worried, some problems/some pain/a bit worried, a lot of problems/a lot of pain/very worried). Scores ranged from <0 (where 0 is the value of a health state equivalent to dead; negative values: values as worse than dead) to 1 (the value of full health), higher scores=higher health utility. Proxy version was filled by care-giver of the subject. Eval-DB population was analysed. Here, ‘N’: number of subjects evaluable for this end point and ‘n’: number of subjects evaluable at specific time points. 99999: data not available.

End point type

Secondary

End point timeframe

Weeks 0, 4, 8 and 12

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	30	23
Units: Units on a scale
arithmetic mean (standard deviation)
Week 0 (n=30, 23)	0.8 ± 0.22	0.8 ± 0.15
Week 4 (n=19, 15)	0.9 ± 0.18	0.9 ± 0.16
Week 8 (n=12, 6)	0.9 ± 0.11	0.8 ± 0.20
Week 12 (n=4, 1)	0.9 ± 0.10	1.0 ± 99999

No statistical analyses for this end point

Secondary: EuroQoL EQ-5D-5L VAS Scores in Subjects >= 18 Years of age: First Flare Period

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End point title

EuroQoL EQ-5D-5L VAS Scores in Subjects >= 18 Years of age: First Flare Period

End point description

The EQ-5D-5L is a participant rated questionnaire that consisted of six questions used to calculate a health utility score. There were two components to the EQ-5D-5L: a five-item health state profile that assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression used to obtain an Index Utility Score, as well as a VAS that measures health state. EQ-5D VAS was used to record subject’s rating for his/her current health-related quality of life state on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state. Eval-DB population was analysed. Here ‘N’:number of subjects evaluable for end point,‘n’:number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Weeks 0, 4, 8 and 12

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	27	28
Units: Units on a scale
arithmetic mean (standard deviation)
Week 0 (n=27, 28)	84.1 ± 10.40	82.8 ± 17.81
Week 4 (n=14, 15)	87.9 ± 8.02	81.1 ± 22.15
Week 8 (n=9, 10)	88.6 ± 6.71	88.2 ± 9.25
Week 12 (n=3, 3)	83.7 ± 11.85	85.0 ± 21.79

No statistical analyses for this end point

Secondary: EuroQoL EQ-5D Y VAS Scores in Subjects Between 8-17 Years of age: First Flare Period

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End point title

EuroQoL EQ-5D Y VAS Scores in Subjects Between 8-17 Years of age: First Flare Period

End point description

EQ-5D-Y: child-friendly version of EQ-5D questionnaire related to health status. Health state profile assessed health in 5 dimensions (Mobility; Looking After Myself; Doing Usual Activities; Having Pain or Discomfort; Feeling Worried, Sad or Unhappy) used to obtain an index score, each of which had three levels of response (no problems/no pain/not worried, some problems/some pain/a bit worried, a lot of problems/a lot of pain/very worried). Scores ranged from <0 (where 0 is the value of a health state equivalent to dead; negative values: values as worse than dead) to 1 (the value of full health), higher scores=higher health utility. Eval-DB population was analysed. Here, ‘N’: number of subjects evaluable for this end point and ‘n’: number of subjects evaluable at specific time points. 99999: data not available.

End point type

Secondary

End point timeframe

Weeks 0, 4, 8 and 12

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	28	22
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n=28, 22)	86.5 ± 10.87	88.7 ± 10.27
Week 4 (n=14, 13)	91.5 ± 8.91	82.3 ± 18.55
Week 8 (n=9, 9)	85.3 ± 17.58	87.0 ± 9.49
Week 12 (n=1, 5)	100.0 ± 99999	81.0 ± 4.18

No statistical analyses for this end point

Secondary: EuroQoL EQ-5D Y Proxy VAS Scores in Subjects Between 2-7 Years of age: First Flare Period

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End point title

EuroQoL EQ-5D Y Proxy VAS Scores in Subjects Between 2-7 Years of age: First Flare Period

End point description

EQ-5D-Y: child-friendly version of EQ-5D questionnaire related to health status. Health state profile assessed health in 5 dimensions (Mobility; Looking After Myself; Doing Usual Activities; Having Pain or Discomfort; Feeling Worried, Sad or Unhappy) used to obtain an index score, each of which had three levels of response (no problems/no pain/not worried, some problems/some pain/a bit worried, a lot of problems/a lot of pain/very worried). Scores ranged from <0 (where 0 is the value of a health state equivalent to dead; negative values: values as worse than dead) to 1 (the value of full health), higher scores=higher health utility. Proxy version was filled by care-giver of the subject. Eval-DB population was analysed. Here, ‘N’: number of subjects evaluable for this end point and ‘n’: number of subjects evaluable at specific time points. 99999: data not available.

End point type

Secondary

End point timeframe

Weeks 0, 4, 8 and 12

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	30	23
Units: Units on a scale
arithmetic mean (standard deviation)
Week 0 (n=30, 23)	84.7 ± 21.55	91.0 ± 7.84
Week 4 (n=19, 15)	90.3 ± 13.53	91.3 ± 7.69
Week 8 (n=12, 6)	93.8 ± 5.29	93.0 ± 7.90
Week 12 (n=4, 1)	90.0 ± 10.61	99.0 ± 99999

No statistical analyses for this end point

Secondary: EuroQoL EQ-5D Y Index Scores in Subjects >= 18 Years of age: First Flare Free Period

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End point title

EuroQoL EQ-5D Y Index Scores in Subjects >= 18 Years of age: First Flare Free Period

End point description

EQ-5D-Y: child-friendly version of EQ-5D questionnaire related to health status. Health state profile assessed health in 5 dimensions (Mobility; Looking After Myself; Doing Usual Activities; Having Pain or Discomfort; Feeling Worried, Sad or Unhappy) used to obtain an index score, each of which had three levels of response (no problems/no pain/not worried, some problems/some pain/a bit worried, a lot of problems/a lot of pain/very worried). Scores ranged from <0 (where 0 is the value of a health state equivalent to dead; negative values: values as worse than dead) to 1 (the value of full health), higher scores=higher health utility. Eval-DB population was analysed. Here, ‘N’: number of subjects evaluable for this end point and ‘n’: number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	46	48
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n=46, 48)	0.9 ± 0.09	0.9 ± 0.11
Week 4 (n=22, 30)	0.9 ± 0.12	0.9 ± 0.10
Week 8 (n=20, 26)	0.9 ± 0.10	0.9 ± 0.09
Week 12 (n=15, 21)	1.0 ± 0.09	0.9 ± 0.09
Week 16 (n=15, 19)	0.9 ± 0.11	0.9 ± 0.10
Week 20 (n=7, 6)	0.9 ± 0.09	0.9 ± 0.15
Week 24 (n=14, 17)	0.9 ± 0.10	0.9 ± 0.10
Week 28 (n=7, 4)	1.0 ± 0.07	1.0 ± 0.00
Week 32 (n=13, 13)	0.9 ± 0.10	0.9 ± 0.12
Week 36 (n=6, 3)	0.9 ± 0.08	1.0 ± 0.00
Week 40 (n=14, 13)	1.0 ± 0.08	0.9 ± 0.18
Week 44 (n=7, 4)	1.0 ± 0.07	1.0 ± 0.07
Week 48 (n=14, 12)	0.9 ± 0.11	0.9 ± 0.11
Week 52 (n=13, 12)	0.9 ± 0.10	0.9 ± 0.12

No statistical analyses for this end point

Secondary: EuroQoL EQ-5D Y Index Scores in Subjects Between 8-17 Years of age: First Flare Free Period

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End point title

EuroQoL EQ-5D Y Index Scores in Subjects Between 8-17 Years of age: First Flare Free Period

End point description

EQ-5D-Y: child-friendly version of EQ-5D questionnaire related to health status. Health state profile assessed health in 5 dimensions (Mobility; Looking After Myself; Doing Usual Activities; Having Pain or Discomfort; Feeling Worried, Sad or Unhappy) used to obtain an index score, each of which had three levels of response (no problems/no pain/not worried, some problems/some pain/a bit worried, a lot of problems/a lot of pain/very worried). Scores ranged from <0 (where 0 is the value of a health state equivalent to dead; negative values: values as worse than dead) to 1 (the value of full health), higher scores=higher health utility. Eval-DB population was analysed. Here, ‘N’: number of subjects evaluable for this end point and ‘n’: number of subjects evaluable at specific time points. 99999: data not available.

End point type

Secondary

End point timeframe

Baseline (the last observation up to and including Day 1 of OL period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	38	43
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n=38, 43)	0.9 ± 0.08	0.9 ± 0.18
Week 4 (n=13, 28)	1.0 ± 0.06	1.0 ± 0.07
Week 8 (n=9, 24)	1.0 ± 0.05	1.0 ± 0.08
Week 12 (n=10, 25)	1.0 ± 0.07	1.0 ± 0.06
Week 16 (n=7, 24)	1.0 ± 0.07	1.0 ± 0.07
Week 20 (n=2, 11)	0.8 ± 0.01	1.0 ± 0.05
Week 24 (n=6, 20)	1.0 ± 0.07	1.0 ± 0.06
Week 28 (n=1, 9)	1.0 ± 99999	1.0 ± 0.07
Week 32 (n=7, 19)	1.0 ± 0.07	1.0 ± 0.07
Week 36 (n=0, 7)	99999 ± 99999	1.0 ± 0.08
Week 40 (n=6, 17)	0.9 ± 0.09	0.9 ± 0.14
Week 44 (n=0, 8)	99999 ± 99999	0.9 ± 0.25
Week 48 (n=5, 16)	1.0 ± 0.08	0.9 ± 0.09
Week 52 (n=4, 15)	1.0 ± 0.09	1.0 ± 0.07

No statistical analyses for this end point

Secondary: EuroQoL EQ-5D Y Proxy Index Scores in Subjects Between 2-7 Years of age: First Flare Free Period

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End point title

EuroQoL EQ-5D Y Proxy Index Scores in Subjects Between 2-7 Years of age: First Flare Free Period

End point description

EQ-5D-Y: child-friendly version of EQ-5D questionnaire related to health status. Health state profile assessed health in 5 dimensions (Mobility; Looking After Myself; Doing Usual Activities; Having Pain or Discomfort; Feeling Worried, Sad or Unhappy) used to obtain an index score, each of which had three levels of response (no problems/no pain/not worried, some problems/some pain/a bit worried, a lot of problems/a lot of pain/very worried). Scores ranged from <0 (where 0 is the value of a health state equivalent to dead; negative values: values as worse than dead) to 1 (the value of full health), higher scores=higher health utility. Proxy version was filled by care-giver of the subject. Eval-DB population was analysed. Here, ‘N’: number of subjects evaluable for this end point and ‘n’: number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline (the last observation up to and including Day 1 of OL period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	41	30
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n=41, 30)	1.0 ± 0.08	0.9 ± 0.12
Week 4 (n=16, 14)	0.9 ± 0.10	0.9 ± 0.14
Week 8 (n=11, 10)	1.0 ± 0.08	1.0 ± 0.08
Week 12 (n=10, 10)	1.0 ± 0.09	1.0 ± 0.06
Week 16 (n=7, 6)	0.9 ± 0.09	1.0 ± 0.00
Week 20 (n=2, 3)	0.9 ± 0.12	1.0 ± 0.00
Week 24 (n=4, 6)	0.9 ± 0.08	1.0 ± 0.00
Week 28 (n=2, 3)	0.9 ± 0.12	0.9 ± 0.09
Week 32 (n=4, 4)	0.9 ± 0.11	1.0 ± 0.00
Week 36 (n=1, 3)	1.0 ± 99999	1.0 ± 0.00
Week 40 (n=4, 3)	0.9 ± 0.11	1.0 ± 0.00
Week 44 (n=1, 1)	1.0 ± 99999	1.0 ± 99999
Week 48 (n=4, 3)	0.9 ± 0.11	1.0 ± 0.00
Week 52 (n=5, 3)	1.0 ± 0.06	1.0 ± 0.00

No statistical analyses for this end point

Secondary: EuroQoL EQ-5D-5L VAS Scores in Subjects >= 18 Years of age: First Flare Free Period

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End point title

EuroQoL EQ-5D-5L VAS Scores in Subjects >= 18 Years of age: First Flare Free Period

End point description

EQ-5D-5L:subject rated questionnaire,6 questions to calculate health utility score. 2 components to EQ-5D-5L: 5-item health state profile assessed 5 dimensions:mobility,self-care,usual activities,pain/discomfort and anxiety/depression used to obtain Index Utility Score,VAS that measures health state. Each dimension:5 levels:1=no problems,2=slight,3=moderate,4=severe,5=extreme.Response to 5 dimensions comprised health state/a single utility index value.Eg. if subject responded"no problems"for each 5 dimensions, health state coded:"11111" with predefined index value to it.Every health state(coded as combination of responses on each of 5 dimensions):unique predefined utility index value assigned to it by EuroQol. US value sets(with all possible health states)used for adults in the study,range from 1 to -0.109. Higher(positive) scores= better health state. Eval-DB population analysed.‘N’:number of subjects evaluable for end point,‘n’:number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline(the last observation up to and including Day 1 of OL period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	46	48
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n=46, 48)	88.3 ± 9.41	85.2 ± 15.56
Week 4 (n=22, 30)	89.6 ± 9.11	86.8 ± 10.74
Week 8 (n=20, 26)	91.3 ± 7.44	88.5 ± 11.29
Week 12 (n=15, 21)	91.9 ± 8.86	83.8 ± 15.36
Week 16 (n=15, 19)	91.3 ± 9.74	86.1 ± 11.88
Week 20 (n=7, 6)	88.1 ± 12.01	87.5 ± 14.01
Week 24 (n=14, 17)	92.6 ± 8.26	88.1 ± 9.77
Week 28 (n=7, 4)	91.9 ± 7.06	96.3 ± 2.75
Week 32 (n=13, 13)	91.5 ± 6.70	89.5 ± 8.88
Week 36 (n=6, 3)	91.3 ± 9.83	92.7 ± 10.12
Week 40 (n=14, 13)	93.1 ± 7.95	87.2 ± 13.76
Week 44 (n=7, 4)	91.1 ± 9.63	88.0 ± 11.78
Week 48 (n=14, 12)	92.5 ± 9.28	92.4 ± 8.17
Week 52 (n=13, 12)	93.7 ± 7.75	88.9 ± 9.70

No statistical analyses for this end point

Secondary: EuroQoL EQ-5D Y VAS Scores in Subjects Between 8-17 Years of age: First Flare Free Period

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End point title

EuroQoL EQ-5D Y VAS Scores in Subjects Between 8-17 Years of age: First Flare Free Period

End point description

EQ-5D-Y: child-friendly version of EQ-5D questionnaire related to health status. Health state profile assessed health in 5 dimensions (Mobility; Looking After Myself; Doing Usual Activities; Having Pain or Discomfort; Feeling Worried, Sad or Unhappy) used to obtain an index score, each of which had three levels of response (no problems/no pain/not worried, some problems/some pain/a bit worried, a lot of problems/a lot of pain/very worried). Scores ranged from <0 (where 0 is the value of a health state equivalent to dead; negative values: values as worse than dead) to 1 (the value of full health), higher scores=higher health utility. Eval-DB population was analysed. Here, ‘N’: number of subjects evaluable for this end point and ‘n’: number of subjects evaluable at specific time points. 99999:data not available.

End point type

Secondary

End point timeframe

Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	38	43
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n=38, 43)	86.8 ± 14.86	91.1 ± 9.34
Week 4 (n=13, 28)	87.7 ± 11.74	91.6 ± 7.27
Week 8 (n=9, 24)	88.8 ± 10.96	87.6 ± 14.84
Week 12 (n=10, 25)	89.8 ± 11.01	87.9 ± 13.70
Week 16 (n=7, 24)	92.9 ± 8.01	87.9 ± 14.74
Week 20 (n=2, 11)	84.0 ± 12.73	86.1 ± 23.22
Week 24 (n=6, 20)	92.7 ± 12.04	89.8 ± 13.76
Week 28 (n=1. 9)	96.0 ± 99999	86.6 ± 15.40
Week 32 (n=7, 19)	92.1 ± 8.43	88.8 ± 14.68
Week 36 (n=0, 7)	99999 ± 99999	89.0 ± 18.25
Week 40 (n=6, 17)	95.2 ± 4.75	89.6 ± 14.01
Week 44 (n=0, 8)	99999 ± 99999	88.0 ± 16.46
Week 48 (n=5, 16)	93.8 ± 7.50	89.1 ± 15.72
Week 52 (n=4, 15)	98.5 ± 1.91	90.7 ± 13.53

No statistical analyses for this end point

Secondary: EuroQoL EQ-5D Y Proxy VAS Scores in Subjects Between 2-7 Years of age: First Flare Free Period

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End point title

EuroQoL EQ-5D Y Proxy VAS Scores in Subjects Between 2-7 Years of age: First Flare Free Period

End point description

EQ-5D-Y: child-friendly version of EQ-5D questionnaire related to health status. Health state profile assessed health in 5 dimensions (Mobility; Looking After Myself; Doing Usual Activities; Having Pain or Discomfort; Feeling Worried, Sad or Unhappy) used to obtain an index score, each of which had three levels of response (no problems/no pain/not worried, some problems/some pain/a bit worried, a lot of problems/a lot of pain/very worried). Scores ranged from <0 (where 0 is the value of a health state equivalent to dead; negative values: values as worse than dead) to 1 (the value of full health), higher scores=higher health utility. Proxy version was filled by care-giver of the subject. Eval-DB population was analysed. Here, ‘N’: number of subjects evaluable for this end point and ‘n’: number of subjects evaluable at specific time points. 99999: data not available.

End point type

Secondary

End point timeframe

Baseline (the last observation up to and including Day 1 of OL period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	41	30
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n=41, 30)	93.8 ± 9.97	94.3 ± 8.16
Week 4 (n=16, 14)	94.6 ± 6.05	96.3 ± 6.54
Week 8 (n=11, 10)	94.3 ± 7.06	96.0 ± 7.29
Week 12 (n=10, 10)	94.4 ± 5.95	98.3 ± 2.26
Week 16 (n=7, 6)	93.7 ± 8.22	98.2 ± 2.23
Week 20 (n=2, 3)	96.5 ± 4.95	93.7 ± 10.97
Week 24 (n=4, 6)	90.0 ± 8.49	95.7 ± 5.01
Week 28 (n=2, 3)	100.0 ± 0.00	100.0 ± 0.00
Week 32 (n=4, 4)	92.0 ± 8.45	97.8 ± 1.71
Week 36 (n=1, 3)	100.0 ± 99999	98.3 ± 2.89
Week 40 (n=4, 3)	91.5 ± 9.33	99.3 ± 0.58
Week 44 (n=1, 1)	100.0 ± 99999	100.0 ± 99999
Week 48 (4, 3)	94.0 ± 5.35	99.0 ± 1.73
Week 52 (n=5, 3)	96.4 ± 4.16	98.7 ± 2.31

No statistical analyses for this end point

Secondary: Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period

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End point title

Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period

End point description

WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days.Questions were:Q1=currently employed;Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons;Q4=hours actually worked; Q5 = degree health affected productivity while working (0-10 scale,high=less productivity);Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale, high= productivity);Q10=degree health affected productivity in regular daily activities(0-10 scale,high=less productivity). Percent work time missed due to health problem calculated as: Q2*100/(Q2+Q4) and score ranged from 0-100%,higher numbers=greater impairment and less productivity. Eval-OL population analysed.‘N’:number of subjects evaluable for this end point, ‘n’: number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline (last observation up to and including the randomisation day), Weeks 2, 4, 6 and 8

End point values	Crisaborole 2% BID
Number of subjects analysed	135
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n=125)	5.75 ± 16.796
Week 2 (n=131)	4.72 ± 15.553
Week 4 (n=133)	5.92 ± 16.487
Week 6 (n=134)	4.83 ± 14.801
Week 8 (n=135)	6.96 ± 18.080

No statistical analyses for this end point

Secondary: Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period

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End point title

Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period

End point description

WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days.Questions:Q1=currently employed;Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons;Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high=less productivity); Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale,high= productivity);Q10=degree health affected productivity in regular daily activities(0-10 scale,high=less productivity).Percent impairment while working due to health problem calculated as: 100*Q5/10 score ranged from 0-100%,higher numbers=greater impairment and less productivity. Eval-OL population analysed.‘N’:number of subjects evaluable for this end point,‘n’:number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Weeks 0, 2, 4, 6 and 8

End point values	Crisaborole 2% BID
Number of subjects analysed	135
Units: Units on a scale
arithmetic mean (standard deviation)
Week 0 (n=124)	32.66 ± 28.602
Week 2 (n=131)	17.02 ± 21.293
Week 4 (n=133)	15.26 ± 20.285
Week 6 (n=134)	14.10 ± 20.417
Week 8 (n=135)	14.37 ± 20.898

No statistical analyses for this end point

Secondary: Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period

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End point title

Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period

End point description

WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past7days.Questions:Q1=currently employed;Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons;Q4=hours actually worked;Q5=degree health affected productivity while working(0-10 scale,high=less productivity);Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale,high= productivity);Q10=degree health affected productivity:regular daily activities(0-10 scale,high=less productivity).Percent overall impairment while working due to health problem calculated as:100*{Q2/(Q2+Q4)+[(1- Q2/(Q2+Q4))×(Q5/10)]},score ranged:0-100%,high numbers=greater impairment and less productivity.Eval-OL population analysed.‘N’:number of subjects evaluable for the end point,‘n’:number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Weeks 0, 2, 4, 6 and 8

End point values	Crisaborole 2% BID
Number of subjects analysed	275
Units: Units on a scale
arithmetic mean (standard deviation)
Week 0 (n=124)	34.77 ± 30.179
Week 2 (n=131)	20.10 ± 23.627
Week 4 (n=133)	19.30 ± 23.220
Week 6 (n=134)	17.43 ± 22.620
Week 8 (n=135)	19.36 ± 24.564

No statistical analyses for this end point

Secondary: Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period

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End point title

Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period

End point description

WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions:Q1=currently employed;Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons;Q4=hours actually worked;Q5=degree health affected productivity while working(0-10 scale,high=less productivity);Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale, high= productivity);Q10=degree health affected productivity in regular daily activities(0-10 scale, high=less productivity).Percent class time missed due to health problem calculated as: Q7*100/(Q7+Q8) and score ranged from 0-100% where higher numbers=greater impairment and less productivity. Eval-OL population analysed. ‘N’: number of subjects evaluable for this end point and ‘n’: number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Weeks 2, 4, 6 and 8

End point values	Crisaborole 2% BID
Number of subjects analysed	118
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n=83)	4.14 ± 14.982
Week 2 (n=98)	5.26 ± 16.664
Week 4 (n=108)	3.94 ± 12.968
Week 6 (n=117)	4.71 ± 13.991
Week 8 (n=118)	4.55 ± 14.584

No statistical analyses for this end point

Secondary: Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period

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End point title

Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period

End point description

WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions:Q1=currently employed;Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons;Q4=hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, high=less productivity); Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale, high= productivity);Q10=degree health affected productivity in regular daily activities(0-10 scale, high=less productivity). Percent impairment while in class was calculated as: 100*Q9/10 and score ranged from 0-100% where higher numbers indicate greater impairment and less productivity. Eval-OL population analysed. ‘N’: number of subjects evaluable for this end point and ‘n’: number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Weeks 2, 4, 6 and 8

End point values	Crisaborole 2% BID
Number of subjects analysed	119
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n=82)	26.46 ± 22.683
Week 2 (n=98)	17.55 ± 19.639
Week 4 (n=108)	15.37 ± 19.879
Week 6 (n=118)	13.31 ± 19.527
Week 8 (n=119)	12.69 ± 17.789

No statistical analyses for this end point

Secondary: Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period

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End point title

Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period

End point description

WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past7days.Questions:Q1=currently employed;Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons;Q4=hours actually worked;Q5=degree health affected productivity while working (0-10 scale,high=less productivity);Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale,high= productivity);Q10=degree health affected productivity in regular daily activities(0-10 scale, high=less productivity).Percent overall class impairment due to health problem calculated as: 100*{Q7/(Q7+Q8)+[(1- Q7/(Q7+Q8))×(Q9/10)]},score range:0-100%,higher numbers=greater impairment and less productivity.Eval-OL population analysed.‘N’:number of subjects evaluable for this end point,‘n’:number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Weeks 2, 4, 6 and 8

End point values	Crisaborole 2% BID
Number of subjects analysed	118
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n=82)	28.20 ± 24.171
Week 2 (n=98)	20.27 ± 22.676
Week 4 (n=108)	18.13 ± 22.977
Week 6 (n=117)	17.01 ± 23.126
Week 8 (n=118)	16.20 ± 22.148

No statistical analyses for this end point

Secondary: Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period

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End point title

Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period

End point description

WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days.Questions:Q1=currently employed;Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons;Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high=less productivity); Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale,high= productivity);Q10=degree health affected productivity in regular daily activities(0-10 scale, high=less productivity). Percent activity impairment due to health problem calculated as: 100*Q10/10, score ranged from 0-100%,higher numbers=greater impairment and less productivity.Eval-OL population analysed.‘N’:number of subjects evaluable for this end point,‘n’:number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Weeks 2, 4, 6 and 8

End point values	Crisaborole 2% BID
Number of subjects analysed	273
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n=268)	28.21 ± 28.766
Week 2 (n=271)	15.83 ± 20.036
Week 4 (n=273)	14.54 ± 20.162
Week 6 (n=273)	13.81 ± 20.547
Week 8 (n=273)	13.55 ± 19.783

No statistical analyses for this end point

Secondary: Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period

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End point title

Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period

End point description

WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days.Questions were:Q1=currently employed;Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons;Q4=hours actually worked; Q5 = degree health affected productivity while working (0-10 scale,high=less productivity);Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale, high= productivity);Q10=degree health affected productivity in regular daily activities(0-10 scale,high=less productivity). Percent work time missed due to health problem calculated as: Q2*100/(Q2+Q4) and score ranged from 0-100%,higher numbers=greater impairment and less productivity. Eval-DB population analysed.‘N’:number of subjects evaluable for this end point, ‘n’: number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	35	38
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n=35, 38)	4.77 ± 14.528	5.07 ± 14.128
Week 4 (n=11, 18)	5.67 ± 14.861	5.54 ± 15.120
Week 8 (n=13, 17)	5.48 ± 14.237	2.99 ± 12.345
Week 12 (n=13, 15)	3.98 ± 13.835	3.85 ± 12.970
Week 16 (n=18, 21)	14.84 ± 30.656	3.55 ± 10.903
Week 20 (n=8, 6)	4.34 ± 9.633	0.37 ± 0.898
Week 24 (n=15, 18)	0.37 ± 0.997	7.24 ± 17.750
Week 28 (n=5, 5)	0.36 ± 0.805	0.82 ± 1.834
Week 32 (n=13, 18)	5.55 ± 14.500	9.22 ± 25.636
Week 36 (n=5, 5)	5.00 ± 11.180	0.84 ± 1.878
Week 40 (n=15, 18)	1.91 ± 6.181	3.02 ± 11.770
Week 44 (n=6, 6)	0.27 ± 0.653	0.70 ± 1.715
Week 48 (n=12, 15)	1.44 ± 3.746	11.51 ± 21.033
Week 52 (n=15, 16)	11.27 ± 20.344	5.00 ± 12.884

No statistical analyses for this end point

Secondary: Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period

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End point title

Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period

End point description

WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days.Questions:Q1=currently employed;Q2=hours missed due to health problems;Q3=hours missed due to other reasons;Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high=less productivity); Q6=classes attended in academic setting or not;Q7=hours missed due to health problems;Q8=hours actually attended;Q9=degree health affected productivity while attending(0-10 scale,high= productivity);Q10=degree health affected productivity in regular daily activities(0-10 scale,high=less productivity).Percent impairment while working due to health problem calculated as: 100*Q5/10 score ranged from 0-100%,higher numbers=greater impairment and less productivity. Eval-DB population analysed.‘N’:number of subjects evaluable for this end point,‘n’:number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	35	38
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n=35, 38)	9.71 ± 15.432	10.26 ± 17.474
Week 4 (n=11, 18)	4.55 ± 12.136	10.56 ± 15.136
Week 8 (n=13, 17)	6.15 ± 7.679	5.29 ± 12.805
Week 12 (n=13, 15)	6.92 ± 8.549	8.00 ± 20.771
Week 16 (n=17, 21)	11.76 ± 15.506	5.24 ± 14.359
Week 20 (n=8, 6)	11.25 ± 15.526	3.33 ± 5.164
Week 24 (n=15, 18)	8.00 ± 8.619	8.89 ± 20.260
Week 28 (n=5, 5)	12.00 ± 13.038	0.00 ± 0.000
Week 32 (n=13, 17)	7.69 ± 8.321	9.41 ± 15.996
Week 36 (n=5, 5)	10.00 ± 10.000	10.00 ± 10.000
Week 40 (n=15, 18)	9.33 ± 10.998	10.56 ± 19.844
Week 44 (n=6, 6)	21.67 ± 32.506	11.67 ± 24.014
Week 48 (n=12, 15)	9.17 ± 9.003	13.33 ± 21.269
Week 52 (n=15, 16)	8.00 ± 9.411	10.63 ± 20.484

No statistical analyses for this end point

Secondary: Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period

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End point title

Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period

End point description

WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past7days.Questions:Q1=currently employed;Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons;Q4=hours actually worked;Q5=degree health affected productivity while working(0-10 scale,high=less productivity);Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale,high= productivity);Q10=degree health affected productivity:regular daily activities(0-10 scale,high=less productivity).Percent overall impairment while working due to health problem calculated as:100*{Q2/(Q2+Q4)+[(1- Q2/(Q2+Q4))×(Q5/10)]},score ranged:0-100%,high numbers=greater impairment and less productivity.Eval-DB population analysed.‘N’:number of subjects evaluable for the end point,‘n’:number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	35	38
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n=35, 38)	14.04 ± 19.991	14.29 ± 21.183
Week 4 (n=11, 18)	10.20 ± 17.730	15.53 ± 20.088
Week 8 (n=13, 17)	11.46 ± 14.980	8.29 ± 16.813
Week 12 (n=13, 15)	10.11 ± 16.906	9.13 ± 23.216
Week 16 (n=17, 21)	21.06 ± 24.410	7.17 ± 19.121
Week 20 (n=8, 6)	15.15 ± 17.456	3.67 ± 5.715
Week 24 (n=15, 18)	8.33 ± 8.906	15.35 ± 25.202
Week 28 (n=5, 5)	12.32 ± 12.997	0.82 ± 1.834
Week 32 (n=13, 17)	12.69 ± 16.267	11.35 ± 20.568
Week 36 (n=5, 5)	14.50 ± 14.186	10.76 ± 10.143
Week 40 (n=15, 18)	11.01 ± 12.629	11.33 ± 21.941
Week 44 (n=6, 6)	21.93 ± 32.299	12.37 ± 23.664
Week 48 (n=12, 15)	10.36 ± 10.518	20.64 ± 28.599
Week 52 (n=15, 16)	17.91 ± 21.428	14.68 ± 23.128

No statistical analyses for this end point

Secondary: Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period

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End point title

Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period

End point description

WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions:Q1=currently employed;Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons;Q4=hours actually worked;Q5=degree health affected productivity while working(0-10 scale,high=less productivity);Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale, high= productivity);Q10=degree health affected productivity in regular daily activities(0-10 scale, high=less productivity).Percent class time missed due to health problem calculated as: Q7*100/(Q7+Q8) and score ranged from 0-100% where higher numbers=greater impairment and less productivity. Eval-DB population analysed. ‘N’: number of subjects evaluable for this end point and ‘n’: number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline (the last observation up to and including Day 1 of DB period),Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	29	33
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n=29, 33)	0.04 ± 0.223	2.22 ± 9.030
Week 4 (n=12, 22)	0.89 ± 3.089	1.14 ± 5.330
Week 8 (n=12, 19)	0.00 ± 0.000	1.62 ± 6.735
Week 12 (n=8, 18)	11.36 ± 32.138	3.09 ± 11.781
Week 16 (n=9, 14)	0.00 ± 0.000	7.64 ± 23.561
Week 20 (n=7, 9)	7.79 ± 20.599	0.00 ± 0.000
Week 24 (n=8, 20)	0.00 ± 0.000	3.62 ± 9.881
Week 28 (n=5, 7)	0.00 ± 0.000	0.00 ± 0.000
Week 32 (n=8, 20)	0.00 ± 0.000	5.83 ± 15.897
Week 36 (n=4, 4)	0.00 ± 0.000	0.00 ± 0.000
Week 40 (n=5, 14)	0.00 ± 0.000	3.57 ± 13.363
Week 44 (n=5, 6)	0.00 ± 0.000	0.00 ± 0.000
Week 48 (n=9, 17)	11.11 ± 33.333	0.00 ± 0.000
Week 52 (n=7, 22)	5.71 ± 15.119	9.09 ± 25.054

No statistical analyses for this end point

Secondary: Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period

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End point title

Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period

End point description

WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions:Q1=currently employed;Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons;Q4=hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, high=less productivity); Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale, high= productivity);Q10=degree health affected productivity in regular daily activities(0-10 scale, high=less productivity). Percent impairment while in class was calculated as: 100*Q9/10 and score ranged from 0-100% where higher numbers indicate greater impairment and less productivity. Eval-DB population analysed. ‘N’: number of subjects evaluable for this end point and ‘n’: number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	29	33
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n=29, 33)	8.62 ± 14.072	7.88 ± 11.390
Week 4 (n=12, 22)	5.83 ± 12.401	6.36 ± 12.168
Week 8 (n=12, 19)	4.17 ± 7.930	5.79 ± 8.377
Week 12 (n=8, 18)	3.75 ± 7.440	2.22 ± 7.321
Week 16 (n=9, 14)	7.78 ± 16.415	8.57 ± 10.271
Week 20 (n=7, 9)	11.43 ± 16.762	11.11 ± 26.667
Week 24 (n=8, 20)	8.75 ± 18.077	4.00 ± 7.539
Week 28 (n=5, 7)	10.00 ± 22.361	7.14 ± 11.127
Week 32 (n=8, 20)	3.75 ± 10.607	3.50 ± 9.333
Week 36 (n=4, 4)	2.50 ± 5.000	2.50 ± 5.000
Week 40 (n=5, 14)	2.00 ± 4.472	8.57 ± 14.064
Week 44 (n=5, 6)	10.00 ± 14.142	6.67 ± 8.165
Week 48 (n=8, 17)	7.50 ± 13.887	7.06 ± 12.127
Week 52 (n=7, 21)	1.43 ± 3.780	7.62 ± 14.458

No statistical analyses for this end point

Secondary: Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period

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End point title

Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period

End point description

WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past7days.Questions:Q1=currently employed;Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons;Q4=hours actually worked;Q5=degree health affected productivity while working (0-10 scale,high=less productivity);Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale,high= productivity);Q10=degree health affected productivity in regular daily activities(0-10 scale, high=less productivity).Percent overall class impairment due to health problem calculated as: 100*{Q7/(Q7+Q8)+[(1- Q7/(Q7+Q8))×(Q9/10)]},score range:0-100%,higher numbers=greater impairment and less productivity.Eval-DB population analysed.‘N’:number of subjects evaluable for this end point,‘n’:number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	29	33
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n=29, 33)	8.64 ± 14.136	10.10 ± 13.237
Week 4 (n=12, 22)	6.37 ± 14.034	7.50 ± 12.701
Week 8 (n=12, 19)	4.17 ± 7.930	7.40 ± 9.858
Week 12 (n=8, 18)	15.11 ± 31.477	5.28 ± 13.559
Week 16 (n=9, 14)	7.78 ± 16.415	14.06 ± 24.697
Week 20 (n=7, 9)	18.44 ± 24.535	11.11 ± 26.667
Week 24 (n=8, 20)	8.75 ± 18.077	7.20 ± 13.260
Week 28 (n=5, 7)	10.00 ± 22.361	7.14 ± 11.127
Week 32 (n=8, 20)	3.75 ± 10.607	9.06 ± 18.186
Week 36 (n=4, 4)	2.50 ± 5.000	2.50 ± 5.000
Week 40 (n=5, 14)	2.00 ± 4.472	11.79 ± 18.771
Week 44 (n=5, 6)	10.00 ± 14.142	6.67 ± 8.165
Week 48 (n=8, 17)	7.50 ± 13.887	7.06 ± 12.127
Week 52 (n=7, 21)	7.14 ± 14.960	11.90 ± 20.154

No statistical analyses for this end point

Secondary: Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period

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End point title

Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period

End point description

WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days.Questions:Q1=currently employed;Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons;Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high=less productivity); Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale,high= productivity);Q10=degree health affected productivity in regular daily activities(0-10 scale, high=less productivity). Percent activity impairment due to health problem calculated as: 100*Q10/10, score ranged from 0-100%,higher numbers=greater impairment and less productivity.Eval-DB population analysed.‘N’:number of subjects evaluable for this end point,‘n’:number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	69	78
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n=69, 78)	8.99 ± 15.353	10.90 ± 16.763
Week 4 (n=32, 51)	10.31 ± 18.749	8.24 ± 13.222
Week 8 (n=36, 50)	8.61 ± 13.555	7.20 ± 12.784
Week 12 (n=32, 49)	10.31 ± 16.749	5.31 ± 13.087
Week 16 (n=42, 52)	10.00 ± 15.927	7.12 ± 14.731
Week 20 (n=21, 21)	16.19 ± 22.017	9.52 ± 21.089
Week 24 (n=37, 47)	8.38 ± 13.645	5.74 ± 12.810
Week 28 (n=18, 17)	11.67 ± 16.891	5.29 ± 12.805
Week 32 (n=34, 45)	9.12 ± 17.815	6.89 ± 14.744
Week 36 (n=17, 17)	11.18 ± 15.363	9.41 ± 13.449
Week 40 (n=34, 47)	10.59 ± 18.081	8.30 ± 17.235
Week 44 (n=18, 17)	13.33 ± 21.693	7.65 ± 16.781
Week 48 (n=30, 43)	11.00 ± 16.263	6.05 ± 13.997
Week 52 (n=32, 43)	7.50 ± 14.368	7.21 ± 15.480

No statistical analyses for this end point

Secondary: Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period

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End point title

Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period

End point description

WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days.Questions were:Q1=currently employed;Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons;Q4=hours actually worked; Q5 = degree health affected productivity while working (0-10 scale,high=less productivity);Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale, high= productivity);Q10=degree health affected productivity in regular daily activities(0-10 scale,high=less productivity). Percent work time missed due to health problem calculated as: Q2*100/(Q2+Q4) and score ranged from 0-100%,higher numbers=greater impairment and less productivity. Eval-DB population analysed.‘N’:number of subjects evaluable for this end point, ‘n’: number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	35	38
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n=35, 38)	4.77 ± 14.528	5.07 ± 14.128
Week 4 (n=10, 18)	5.76 ± 15.662	5.54 ± 15.120
Week 8 (n=9, 14)	7.50 ± 16.965	3.64 ± 13.604
Week 12 (n=7, 10)	7.14 ± 18.898	5.77 ± 15.790
Week 16 (n=7, 14)	23.49 ± 38.319	5.32 ± 13.142
Week 20 (n=2, 3)	0.00 ± 0.000	0.73 ± 1.270
Week 24 (n=7, 10)	0.34 ± 0.907	8.03 ± 18.722
Week 28 (n=2, 2)	0.00 ± 0.000	2.05 ± 2.899
Week 32 (n=6, 11)	11.75 ± 20.454	15.08 ± 31.936
Week 36 (n=2, 3)	0.00 ± 0.000	1.40 ± 2.425
Week 40 (n=7, 11)	0.69 ± 1.814	4.95 ± 15.001
Week 44 (n=3, 3)	0.00 ± 0.000	1.40 ± 2.425
Week 48 (n=7, 10)	1.79 ± 4.725	12.27 ± 21.541
Week 52 (n=6, 9)	8.33 ± 20.412	3.33 ± 6.022

No statistical analyses for this end point

Secondary: Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period

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End point title

Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period

End point description

End point type

Secondary

End point timeframe

Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	35	38
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n=35, 38)	9.71 ± 15.432	10.26 ± 17.474
Week 4 (n=10, 18)	5.00 ± 12.693	10.56 ± 15.136
Week 8 (n=9, 14)	4.44 ± 5.270	6.43 ± 13.927
Week 12 (n=7, 10)	5.71 ± 7.868	12.00 ± 24.855
Week 16 (n=6, 14)	8.33 ± 11.690	7.86 ± 17.177
Week 20 (n=2, 3)	15.00 ± 21.213	6.67 ± 5.774
Week 24 (n=7, 10)	8.57 ± 8.997	13.00 ± 25.408
Week 28 (n=2, 2)	10.00 ± 14.142	0.00 ± 0.000
Week 32 (n=6, 10)	8.33 ± 7.528	15.00 ± 19.003
Week 36 (n=2, 3)	10.00 ± 14.142	10.00 ± 10.000
Week 40 (n=7, 11)	12.86 ± 11.127	14.55 ± 23.394
Week 44 (n=3, 3)	30.00 ± 43.589	23.33 ± 32.146
Week 48 (n=7, 10)	11.43 ± 8.997	16.00 ± 24.585
Week 52 (n=6, 9)	8.33 ± 7.528	15.56 ± 25.055

No statistical analyses for this end point

Secondary: Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period

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End point title

Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period

End point description

WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past7days.Questions:Q1=currently employed;Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons;Q4=hours actually worked;Q5=degree health affected productivity while working(0-10 scale,high=less productivity);Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale,high= productivity);Q10=degree health affected productivity:regular daily activities(0-10 scale,high=less productivity).Percent overall impairment while working due to health problem calculated as:100*{Q2/(Q2+Q4)+[(1- Q2/(Q2+Q4))×(Q5/10)]},score ranged:0-100%,high numbers=greater impairment and less productivity.Eval-DB population analysed.‘N’:number of subjects evaluable for the end point,‘n’:number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	35	38
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n=35, 38)	14.04 ± 19.991	14.29 ± 21.183
Week 4 (n=10, 18)	10.74 ± 18.593	15.53 ± 20.088
Week 8 (n=9, 14)	11.77 ± 16.662	10.06 ± 18.129
Week 12 (n=7, 10)	11.43 ± 21.931	13.70 ± 27.729
Week 16 (n=6, 14)	17.57 ± 23.791	10.75 ± 22.825
Week 20 (n=2, 3)	15.00 ± 21.213	7.33 ± 6.429
Week 24 (n=7, 10)	8.86 ± 9.442	19.63 ± 29.412
Week 28 (n=2, 2)	10.00 ± 14.142	2.05 ± 2.899
Week 32 (n=6, 10)	18.92 ± 20.929	18.29 ± 24.749
Week 36 (n=2, 3)	10.00 ± 14.142	11.27 ± 10.238
Week 40 (n=7, 11)	13.40 ± 11.616	15.82 ± 26.160
Week 44 (n=3, 3)	30.00 ± 43.589	24.73 ± 30.679
Week 48 (n=7, 10)	12.86 ± 11.127	23.46 ± 29.836
Week 52 (n=6, 9)	15.83 ± 20.595	17.20 ± 25.996

No statistical analyses for this end point

Secondary: Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period

Top of page

End point title

Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period

End point description

WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions:Q1=currently employed;Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons;Q4=hours actually worked;Q5=degree health affected productivity while working(0-10 scale,high=less productivity);Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale, high= productivity);Q10=degree health affected productivity in regular daily activities(0-10 scale, high=less productivity).Percent class time missed due to health problem calculated as: Q7*100/(Q7+Q8) and score ranged from 0-100% where higher numbers=greater impairment and less productivity. Eval-DB population analysed. ‘N’: number of subjects evaluable for this end point and ‘n’: number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	29	33
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n=29, 33)	0.04 ± 0.223	2.22 ± 9.030
Week 4 (n=11, 22)	0.97 ± 3.226	1.14 ± 5.330
Week 8 (n=7, 19)	0.00 ± 0.000	1.62 ± 6.735
Week 12 (n=4, 17)	0.00 ± 0.000	3.27 ± 12.118
Week 16 (n=4, 13)	0.00 ± 0.000	8.22 ± 24.416
Week 20 (n=1, 7)	0.00 ± 99999	0.00 ± 0.000
Week 24 (n=2, 14)	0.00 ± 0.000	0.71 ± 2.673
Week 28 (n=0, 4)	99999 ± 99999	0.00 ± 0.000
Week 32 (n=2, 13)	0.00 ± 0.000	8.97 ± 19.226
Week 36 (n=0, 2)	99999 ± 99999	0.00 ± 0.000
Week 40 (n=2, 8)	0.00 ± 0.000	0.00 ± 0.000
Week 44 (n=1, 3)	0.00 ± 99999	0.00 ± 0.000
Week 48 (n=4, 9)	0.00 ± 0.000	0.00 ± 0.000
Week 52 (n=2, 9)	0.00 ± 0.000	0.00 ± 0.000

No statistical analyses for this end point

Secondary: Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period

Top of page

End point title

Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period

End point description

WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions:Q1=currently employed;Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons;Q4=hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, high=less productivity); Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale, high= productivity);Q10=degree health affected productivity in regular daily activities(0-10 scale, high=less productivity). Percent impairment while in class was calculated as: 100*Q9/10 and score ranged from 0-100% where higher numbers indicate greater impairment and less productivity. Eval-DB population analysed. ‘N’: number of subjects evaluable for this end point and ‘n’: number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	29	33
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n=29, 33)	8.62 ± 14.072	7.88 ± 11.390
Week 4 (n=11, 22)	6.36 ± 12.863	6.36 ± 12.168
Week 8 (n=7, 19)	1.43 ± 3.780	5.79 ± 8.377
Week 12 (n=4, 17)	5.00 ± 10.000	2.35 ± 7.524
Week 16 (n=4, 13)	2.50 ± 5.000	8.46 ± 10.682
Week 20 (n=1, 7)	0.00 ± 99999	14.29 ± 29.921
Week 24 (n=2, 14)	10.00 ± 14.142	2.86 ± 6.112
Week 28 (n=0, 4)	99999 ± 99999	10.00 ± 14.142
Week 32 (n=2, 13)	0.00 ± 0.000	3.85 ± 11.209
Week 36 (n=0, 2)	99999 ± 99999	5.00 ± 7.071
Week 40 (n=2, 8)	5.00 ± 7.071	6.25 ± 9.161
Week 44 (n=1, 3)	20.00 ± 99999	10.00 ± 10.000
Week 48 (n=4, 9)	7.50 ± 15.000	5.56 ± 11.304
Week 52 (n=2, 9)	0.00 ± 0.000	3.33 ± 7.071

No statistical analyses for this end point

Secondary: Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period

Top of page

End point title

Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period

End point description

WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past7days.Questions:Q1=currently employed;Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons;Q4=hours actually worked;Q5=degree health affected productivity while working (0-10 scale,high=less productivity);Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale,high= productivity);Q10=degree health affected productivity in regular daily activities(0-10 scale, high=less productivity).Percent overall class impairment due to health problem calculated as: 100*{Q7/(Q7+Q8)+[(1- Q7/(Q7+Q8))×(Q9/10)]},score range:0-100%,higher numbers=greater impairment and less productivity.Eval-DB population analysed.‘N’:number of subjects evaluable for this end point,‘n’:number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	29	33
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n=29, 33)	8.64 ± 14.136	10.10 ± 13.237
Week 4 (n=11, 22)	6.95 ± 14.568	7.50 ± 12.701
Week 8 (n=7, 19)	1.43 ± 3.780	7.40 ± 9.858
Week 12 (n=4, 17)	5.00 ± 10.000	5.59 ± 13.910
Week 16 (n=4, 13)	2.50 ± 5.000	14.37 ± 25.677
Week 20 (n=1, 7)	0.00 ± 99999	14.29 ± 29.921
Week 24 (n=2, 14)	10.00 ± 14.142	3.50 ± 7.283
Week 28 (n=0, 4)	99999 ± 99999	0.00 ± 8.165
Week 32 (n=2, 13)	0.00 ± 0.000	12.39 ± 21.847
Week 36 (n=0, 2)	99999 ± 99999	5.00 ± 7.071
Week 40 (n=2, 8)	5.00 ± 7.071	6.25 ± 9.161
Week 44 (n=1, 3)	20.00 ± 99999	10.00 ± 10.000
Week 48 (n=4, 9)	7.50 ± 15.000	5.56 ± 11.304
Week 52 (n= 2, 9)	0.00 ± 0.000	3.33 ± 7.071

No statistical analyses for this end point

Secondary: Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period

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End point title

Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period

End point description

WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days.Questions:Q1=currently employed;Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons;Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high=less productivity); Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale,high= productivity);Q10=degree health affected productivity in regular daily activities(0-10 scale, high=less productivity). Percent activity impairment due to health problem calculated as: 100*Q10/10, score ranged from 0-100%,higher numbers=greater impairment and less productivity.Eval-DB population analysed.‘N’:number of subjects evaluable for this end point,‘n’:number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	69	78
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n=69, 78)	8.99 ± 15.353	10.90 ± 16.763
Week 4 (n=30, 51)	11.00 ± 19.182	8.24 ± 13.222
Week 8 (n=25, 44)	10.00 ± 15.275	7.27 ± 13.005
Week 12 (n=20, 40)	10.50 ± 18.202	5.50 ± 13.765
Week 16 (n=19, 37)	8.95 ± 15.949	8.11 ± 15.958
Week 20 (n=8, 13)	15.00 ± 16.903	9.23 ± 22.159
Week 24 (n=17, 31)	8.24 ± 13.339	5.81 ± 13.850
Week 28 (n=7, 9)	17.14 ± 17.995	3.33 ± 7.071
Week 32 (n=16, 27)	11.88 ± 22.574	8.52 ± 17.255
Week 36 (n=6, 7)	15.00 ± 13.784	8.57 ± 8.997
Week 40 (n=17, 26)	12.35 ± 17.864	7.31 ± 16.385
Week 44 (n=7, 9)	15.71 ± 17.182	8.89 ± 16.915
Week 48 (n=17, 24)	11.18 ± 16.539	7.50 ± 16.485
Week 52 (n=15, 23)	12.00 ± 17.403	6.52 ± 16.951

No statistical analyses for this end point

Secondary: Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period

Top of page

End point title

Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period

End point description

WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days.Questions were:Q1=currently employed;Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons;Q4=hours actually worked; Q5 = degree health affected productivity while working (0-10 scale,high=less productivity);Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale, high= productivity);Q10=degree health affected productivity in regular daily activities(0-10 scale,high=less productivity). Percent work time missed due to health problem calculated as: Q2*100/(Q2+Q4) and score ranged from 0-100%,higher numbers=greater impairment and less productivity. Eval-DB population analysed.‘N’:number of subjects evaluable for this end point, ‘n’: number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Weeks 0, 4, 8 and 12

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	19	15
Units: Units on a scale
arithmetic mean (standard deviation)
Week 0 (n=19, 15)	5.46 ± 14.226	6.99 ± 18.460
Week 4 (n=10, 5)	1.49 ± 3.188	0.00 ± 0.000
Week 8 (n=5, 2)	2.36 ± 5.277	0.00 ± 0.000
Week 12 (n=2, 1)	34.40 ± 48.649	0.00 ± 99999

No statistical analyses for this end point

Secondary: Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period

Top of page

End point title

Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period

End point description

End point type

Secondary

End point timeframe

Weeks 0, 4, 8 and 12

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	19	15
Units: Units on a scale
arithmetic mean (standard deviation)
Week 0 (n=19, 15)	11.05 ± 14.868	16.67 ± 31.547
Week 4 (n=10, 5)	12.00 ± 18.738	10.00 ± 10.000
Week 8 (n=5, 2)	8.00 ± 17.889	15.00 ± 21.213
Week 12 (n=2, 1)	50.00 ± 14.142	0.00 ± 99999

No statistical analyses for this end point

Secondary: Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period

Top of page

End point title

Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period

End point description

WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past7days.Questions:Q1=currently employed;Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons;Q4=hours actually worked;Q5=degree health affected productivity while working(0-10 scale,high=less productivity);Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale,high= productivity);Q10=degree health affected productivity:regular daily activities(0-10 scale,high=less productivity).Percent overall impairment while working due to health problem calculated as:100*{Q2/(Q2+Q4)+[(1- Q2/(Q2+Q4))×(Q5/10)]},score ranged:0-100%,high numbers=greater impairment and less productivity.Eval-DB population analysed.‘N’:number of subjects evaluable for the end point,‘n’:number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Weeks 0, 4, 8 and 12

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	19	15
Units: Units on a scale
arithmetic mean (standard deviation)
Week 0 (n=19, 15)	16.21 ± 18.311	20.32 ± 32.634
Week 4 (n=10, 5)	13.40 ± 18.431	10.00 ± 10.000
Week 8 (n=5, 2)	10.36 ± 17.339	15.00 ± 21.213
Week 12 (n=2, 1)	70.65 ± 15.061	0.00 ± 99999

No statistical analyses for this end point

Secondary: Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period

Top of page

End point title

Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period

End point description

WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions:Q1=currently employed;Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons;Q4=hours actually worked;Q5=degree health affected productivity while working(0-10 scale,high=less productivity);Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale, high= productivity);Q10=degree health affected productivity in regular daily activities(0-10 scale, high=less productivity).Percent class time missed due to health problem calculated as: Q7*100/(Q7+Q8) and score ranged from 0-100% where higher numbers=greater impairment and less productivity. Eval-DB population analysed. ‘N’: number of subjects evaluable for this end point and ‘n’: number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Weeks 0, 4, 8 and 12

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	13	16
Units: Units on a scale
arithmetic mean (standard deviation)
Week 0 (n=13, 16)	3.98 ± 12.314	11.53 ± 27.668
Week 4 (n=6, 12)	0.00 ± 0.000	6.82 ± 16.215
Week 8 (n=2, 6)	0.00 ± 0.000	8.33 ± 20.412
Week 12 (n=0, 4)	99999 ± 99999	1.43 ± 2.850

No statistical analyses for this end point

Secondary: Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period

Top of page

End point title

Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period

End point description

WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions:Q1=currently employed;Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons;Q4=hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, high=less productivity); Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale, high= productivity);Q10=degree health affected productivity in regular daily activities(0-10 scale, high=less productivity). Percent impairment while in class was calculated as: 100*Q9/10 and score ranged from 0-100% where higher numbers indicate greater impairment and less productivity. Eval-DB population analysed. ‘N’: number of subjects evaluable for this end point and ‘n’: number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Weeks 0, 4, 8 and 12

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	13	15
Units: Units on a scale
arithmetic mean (standard deviation)
Week 0 (n=13, 15)	13.85 ± 17.578	24.67 ± 28.999
Week 4 (n=6, 12)	16.67 ± 13.663	25.00 ± 25.761
Week 8 (n=2, 6)	30.00 ± 14.142	30.00 ± 26.077
Week 12 (n=0, 4)	99999 ± 99999	40.00 ± 28.284

No statistical analyses for this end point

Secondary: Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period

Top of page

End point title

Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period

End point description

WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past7days.Questions:Q1=currently employed;Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons;Q4=hours actually worked;Q5=degree health affected productivity while working (0-10 scale,high=less productivity);Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale,high= productivity);Q10=degree health affected productivity in regular daily activities(0-10 scale, high=less productivity).Percent overall class impairment due to health problem calculated as: 100*{Q7/(Q7+Q8)+[(1- Q7/(Q7+Q8))×(Q9/10)]},score range:0-100%,higher numbers=greater impairment and less productivity.Eval-DB population analysed.‘N’:number of subjects evaluable for this end point,‘n’:number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Weeks 0, 4, 8 and 12

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	13	15
Units: Units on a scale
arithmetic mean (standard deviation)
Week 0 (n=13, 15)	17.49 ± 19.742	25.60 ± 30.354
Week 4 (n=6, 12)	16.67 ± 13.663	30.21 ± 26.983
Week 8 (n=2, 6)	30.00 ± 14.142	34.17 ± 31.371
Week 12 (n=0, 4)	99999 ± 99999	40.28 ± 28.803

No statistical analyses for this end point

Secondary: Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period

Top of page

End point title

Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period

End point description

WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days.Questions:Q1=currently employed;Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons;Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high=less productivity); Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale,high= productivity);Q10=degree health affected productivity in regular daily activities(0-10 scale, high=less productivity). Percent activity impairment due to health problem calculated as: 100*Q10/10, scores ranged from 0-100%,higher numbers=greater impairment and less productivity.Eval-DB population analysed.‘N’:number of subjects evaluable for this end point,‘n’:number of subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Weeks 0, 4, 8 and 12

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	43	44
Units: Units on a scale
arithmetic mean (standard deviation)
Week 0 (n=43, 44)	14.88 ± 20.745	17.27 ± 23.164
Week 4 (n=21, 24)	15.24 ± 20.401	19.17 ± 21.653
Week 8 (n=13, 15)	13.85 ± 17.578	26.00 ± 28.486
Week 12 (n=3, 7)	16.67 ± 20.817	31.43 ± 29.681

No statistical analyses for this end point

Secondary: Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: OL Run-in Period

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End point title

Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: OL Run-in Period

End point description

HADS was a validated 14-item questionnaire to assess states of anxiety and depression over the past week. HADS consisted of 2 subscales: HADS-Anxiety (HADS-A) and HADS-Depression (HADS-D), each of which comprised of 7 items. Each item was rated on a 4-point scale, with scores ranging from 0 to 3, where higher scores indicated more anxiety/depression symptoms. HADS-A assessed state of generalized anxiety. HADS-A total score =sum of all 7 items with score ranging from 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicated greater severity of anxiety. HADS-D assessed the state of lost interest and diminished pleasure response. HADS-D total score =the sum of all 7 items with score ranging from 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicated greater severity of depression symptoms. Evaluable OL population was analysed. Here, ‘N: ’number of subjects evaluable for this end point.

End point type

Secondary

End point timeframe

Baseline, Weeks 2, 4, 6 and 8

End point values	Crisaborole 2% BID
Number of subjects analysed	270
Units: Units on a scale
arithmetic mean (standard deviation)
Anxiety: Baseline	5.3 ± 3.70
Anxiety: Week 2	5.3 ± 3.73
Anxiety: Week 4	5.3 ± 3.72
Anxiety: Week 6	5.4 ± 3.79
Anxiety: Week 8	5.4 ± 3.81
Depression: Baseline	3.2 ± 3.09
Depression: Week 2	3.2 ± 3.09
Depression: Week 4	3.2 ± 3.11
Depression: Week 6	3.3 ± 3.16
Depression: Week 8	3.3 ± 3.21

No statistical analyses for this end point

Secondary: Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period

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End point title

Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period

End point description

HADS: validated 14-item questionnaire to assess states of anxiety and depression over the past week. HADS consisted of 2 subscales: HADS-A and HADS-D, each of which comprised of 7 items. Each item was rated on a 4-point scale, with scores ranging from 0 to 3, where higher scores indicated more anxiety/depression symptoms. HADS-A assessed state of generalized anxiety. HADS-A total score =sum of all 7 items with score ranging from 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicated greater severity of anxiety. HADS-D assessed the state of lost interest and diminished pleasure response. HADS-D total score =the sum of all 7 items with score ranging from 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicated greater severity of depression symptoms. Evaluable DB population was analysed. Here, ‘N’: number of subjects evaluable for this end point and n: subjects evaluable at specified time points.

End point type

Secondary

End point timeframe

Baseline, Week 8, 16, 32 and end of treatment (Week 52)

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	67	77
Units: Units on a scale
arithmetic mean (standard deviation)
Anxiety: Baseline (n=66,77)	4.5 ± 3.50	4.5 ± 3.59
Anxiety: Week 8 (n=31, 50)	3.6 ± 3.23	4.5 ± 3.09
Anxiety: Week 16 (n=38, 48)	4.6 ± 3.83	4.7 ± 3.58
Anxiety: Week 32 (n=35, 47)	3.3 ± 3.42	4.4 ± 4.00
Anxiety: End of treatment (n=35, 49)	4.0 ± 3.95	4.7 ± 3.62
Depression: Baseline (n=66, 77)	2.7 ± 2.36	2.8 ± 2.94
Depression: Week 8 (n=31, 50)	2.1 ± 2.00	2.5 ± 2.65
Depression: Week 16 (n=38, 48)	2.9 ± 2.65	3.5 ± 3.76
Depression: Week 32 (n=35, 47)	2.6 ± 2.82	3.3 ± 3.76
Depression: End of treatment (n=35, 49)	2.8 ± 2.77	3.4 ± 3.23

No statistical analyses for this end point

Secondary: Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Period

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End point title

Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Period

End point description

End point type

Secondary

End point timeframe

Weeks 0, 4, 8 and 12

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	15	18
Units: Units on a scale
arithmetic mean (standard deviation)
Anxiety: Week 0 (n=11, 14)	3.7 ± 3.52	4.9 ± 3.70
Anxiety: Week 4 (n=15, 18)	4.3 ± 3.46	5.8 ± 4.19
Anxiety: Week 8 (n=4, 5)	4.3 ± 1.89	8.0 ± 5.24
Anxiety: Week 12 (n=3, 6)	6.0 ± 1.00	5.0 ± 4.73
Depression: Week 0 (n=11, 14)	2.4 ± 3.07	2.5 ± 3.16
Depression: Week 4 (n=15, 18)	3.1 ± 2.79	4.2 ± 5.19
Depression: Week 8 (n=4, 5)	1.3 ± 1.26	4.8 ± 4.44
Depression: Week 12 (n=3, 6)	1.0 ± 1.00	3.3 ± 2.16

No statistical analyses for this end point

Secondary: Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Free Period

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End point title

Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Free Period

End point description

End point type

Secondary

End point timeframe

Baseline (last observation up to and including the randomisation day), Weeks 8, 16 and 32

End point values	Vehicle QD	Crisaborole 2% QD
Number of subjects analysed	66	77
Units: Units on a scale
arithmetic mean (standard deviation)
Anxiety: Baseline (n=66, 77)	4.5 ± 3.50	4.5 ± 3.59
Anxiety: Week 8 (n=25, 44)	3.8 ± 3.28	4.1 ± 2.74
Anxiety: Week 16 (n=19, 38)	3.9 ± 3.38	4.3 ± 3.49
Anxiety: Week 32 (n=17, 28)	2.9 ± 2.47	4.2 ± 3.79
Depression: Baseline (n=66, 77)	2.7 ± 2.36	2.8 ± 2.94
Depression: Week 8 (n=25, 44)	2.2 ± 2.13	2.2 ± 2.29
Depression: Week 16 (n=19, 38)	2.1 ± 1.91	3.1 ± 3.46
Depression: Week 32 (n=17, 28)	1.9 ± 2.22	3.0 ± 3.00

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms

Adverse event reporting additional description

Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 subject and non-serious in another, or a subject may have experienced both AE and non-SAE. Safety population comprised of all subjects who received at least 1 dose of study intervention during the study.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

v24.1

Reporting group title

OL: Crisaborole 2% BID

Reporting group description

Subjects with mild to moderate AD were administered Crisaborole 2% BID in OL period for maximum duration of up to 8 weeks. The subjects that responded during this period were randomized to DB in a 1:1 ratio and received Crisaborole 2% QD or vehicle for 52 weeks.

Reporting group title

DB: Vehicle

Reporting group description

The subjects that responded during the OL period were randomized to DB period in a 1:1 ratio and received vehicle QD for 52 weeks.

Reporting group title

DB: Crisaborole 2% QD

Reporting group description

The subjects that responded during the OL period were randomized to DB period in a 1:1 ratio and received Crisaborole 2% QD for 52 weeks.

Serious adverse events	OL: Crisaborole 2% BID	DB: Vehicle	DB: Crisaborole 2% QD
Total subjects affected by serious adverse events
subjects affected / exposed	3 / 497 (0.60%)	4 / 135 (2.96%)	3 / 135 (2.22%)
number of deaths (all causes)	0	0	0
number of deaths resulting from adverse events	0	0	0
Injury, poisoning and procedural complications
Foreign body ingestion
subjects affected / exposed	0 / 497 (0.00%)	1 / 135 (0.74%)	0 / 135 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Maternal exposure during pregnancy
subjects affected / exposed	0 / 497 (0.00%)	2 / 135 (1.48%)	0 / 135 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Paternal exposure during pregnancy
subjects affected / exposed	0 / 497 (0.00%)	1 / 135 (0.74%)	0 / 135 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac disorders
Cardiac failure congestive
subjects affected / exposed	0 / 497 (0.00%)	0 / 135 (0.00%)	1 / 135 (0.74%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiomyopathy
subjects affected / exposed	0 / 497 (0.00%)	0 / 135 (0.00%)	1 / 135 (0.74%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Asthma
subjects affected / exposed	1 / 497 (0.20%)	0 / 135 (0.00%)	0 / 135 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bronchospasm
subjects affected / exposed	1 / 497 (0.20%)	0 / 135 (0.00%)	0 / 135 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Dermatitis atopic
subjects affected / exposed	1 / 497 (0.20%)	0 / 135 (0.00%)	0 / 135 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infections and infestations
Application site infection
subjects affected / exposed	1 / 497 (0.20%)	0 / 135 (0.00%)	0 / 135 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Osteomyelitis
subjects affected / exposed	0 / 497 (0.00%)	0 / 135 (0.00%)	1 / 135 (0.74%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	0 / 497 (0.00%)	0 / 135 (0.00%)	1 / 135 (0.74%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Skin infection
subjects affected / exposed	1 / 497 (0.20%)	0 / 135 (0.00%)	0 / 135 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 1%

Non-serious adverse events	OL: Crisaborole 2% BID	DB: Vehicle	DB: Crisaborole 2% QD
Total subjects affected by non serious adverse events
subjects affected / exposed	74 / 497 (14.89%)	41 / 135 (30.37%)	32 / 135 (23.70%)
Injury, poisoning and procedural complications
Skin abrasion
subjects affected / exposed	1 / 497 (0.20%)	0 / 135 (0.00%)	3 / 135 (2.22%)
occurrences all number	1	0	4
Skin laceration
subjects affected / exposed	1 / 497 (0.20%)	1 / 135 (0.74%)	2 / 135 (1.48%)
occurrences all number	1	1	2
Nervous system disorders
Headache
subjects affected / exposed	0 / 497 (0.00%)	1 / 135 (0.74%)	3 / 135 (2.22%)
occurrences all number	0	1	3
General disorders and administration site conditions
Application site erythema
subjects affected / exposed	5 / 497 (1.01%)	1 / 135 (0.74%)	0 / 135 (0.00%)
occurrences all number	6	1	0
Application site pain
subjects affected / exposed	28 / 497 (5.63%)	3 / 135 (2.22%)	1 / 135 (0.74%)
occurrences all number	44	3	1
Pyrexia
subjects affected / exposed	1 / 497 (0.20%)	3 / 135 (2.22%)	1 / 135 (0.74%)
occurrences all number	1	3	1
Application site pruritus
subjects affected / exposed	5 / 497 (1.01%)	1 / 135 (0.74%)	0 / 135 (0.00%)
occurrences all number	5	1	0
Immune system disorders
Allergy to animal
subjects affected / exposed	1 / 497 (0.20%)	2 / 135 (1.48%)	0 / 135 (0.00%)
occurrences all number	1	2	0
Gastrointestinal disorders
Abdominal pain upper
subjects affected / exposed	1 / 497 (0.20%)	3 / 135 (2.22%)	0 / 135 (0.00%)
occurrences all number	1	3	0
Constipation
subjects affected / exposed	0 / 497 (0.00%)	2 / 135 (1.48%)	0 / 135 (0.00%)
occurrences all number	0	2	0
Vomiting
subjects affected / exposed	1 / 497 (0.20%)	2 / 135 (1.48%)	1 / 135 (0.74%)
occurrences all number	2	2	1
Respiratory, thoracic and mediastinal disorders
Asthma
subjects affected / exposed	0 / 497 (0.00%)	2 / 135 (1.48%)	0 / 135 (0.00%)
occurrences all number	0	2	0
Cough
subjects affected / exposed	1 / 497 (0.20%)	3 / 135 (2.22%)	0 / 135 (0.00%)
occurrences all number	1	3	0
Nasal congestion
subjects affected / exposed	0 / 497 (0.00%)	2 / 135 (1.48%)	2 / 135 (1.48%)
occurrences all number	0	2	3
Oropharyngeal pain
subjects affected / exposed	0 / 497 (0.00%)	1 / 135 (0.74%)	3 / 135 (2.22%)
occurrences all number	0	1	5
Rhinitis allergic
subjects affected / exposed	0 / 497 (0.00%)	2 / 135 (1.48%)	1 / 135 (0.74%)
occurrences all number	0	2	1
Skin and subcutaneous tissue disorders
Dermatitis atopic
subjects affected / exposed	12 / 497 (2.41%)	5 / 135 (3.70%)	2 / 135 (1.48%)
occurrences all number	13	5	2
Dermatitis contact
subjects affected / exposed	4 / 497 (0.80%)	4 / 135 (2.96%)	1 / 135 (0.74%)
occurrences all number	4	5	1
Eczema
subjects affected / exposed	4 / 497 (0.80%)	2 / 135 (1.48%)	1 / 135 (0.74%)
occurrences all number	4	2	1
Psychiatric disorders
Insomnia
subjects affected / exposed	0 / 497 (0.00%)	0 / 135 (0.00%)	2 / 135 (1.48%)
occurrences all number	0	0	2
Sleep disorder
subjects affected / exposed	0 / 497 (0.00%)	0 / 135 (0.00%)	2 / 135 (1.48%)
occurrences all number	0	0	2
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	1 / 497 (0.20%)	2 / 135 (1.48%)	0 / 135 (0.00%)
occurrences all number	1	2	0
Pain in extremity
subjects affected / exposed	0 / 497 (0.00%)	1 / 135 (0.74%)	2 / 135 (1.48%)
occurrences all number	0	1	2
Infections and infestations
Application site infection
subjects affected / exposed	6 / 497 (1.21%)	5 / 135 (3.70%)	2 / 135 (1.48%)
occurrences all number	6	7	2
Bronchitis
subjects affected / exposed	2 / 497 (0.40%)	3 / 135 (2.22%)	0 / 135 (0.00%)
occurrences all number	2	3	0
COVID-19
subjects affected / exposed	0 / 497 (0.00%)	1 / 135 (0.74%)	6 / 135 (4.44%)
occurrences all number	0	1	6
Conjunctivitis
subjects affected / exposed	1 / 497 (0.20%)	2 / 135 (1.48%)	0 / 135 (0.00%)
occurrences all number	1	2	0
Folliculitis
subjects affected / exposed	0 / 497 (0.00%)	3 / 135 (2.22%)	1 / 135 (0.74%)
occurrences all number	0	3	1
Hand-foot-and-mouth disease
subjects affected / exposed	0 / 497 (0.00%)	1 / 135 (0.74%)	2 / 135 (1.48%)
occurrences all number	0	1	2
Influenza
subjects affected / exposed	4 / 497 (0.80%)	1 / 135 (0.74%)	3 / 135 (2.22%)
occurrences all number	4	1	4
Nasopharyngitis
subjects affected / exposed	4 / 497 (0.80%)	5 / 135 (3.70%)	1 / 135 (0.74%)
occurrences all number	4	5	1
Otitis media
subjects affected / exposed	1 / 497 (0.20%)	1 / 135 (0.74%)	2 / 135 (1.48%)
occurrences all number	1	1	4
Oral herpes
subjects affected / exposed	0 / 497 (0.00%)	0 / 135 (0.00%)	2 / 135 (1.48%)
occurrences all number	0	0	3
Rhinitis
subjects affected / exposed	0 / 497 (0.00%)	2 / 135 (1.48%)	2 / 135 (1.48%)
occurrences all number	0	2	2
Upper respiratory tract infection
subjects affected / exposed	10 / 497 (2.01%)	3 / 135 (2.22%)	5 / 135 (3.70%)
occurrences all number	11	3	5
Urinary tract infection
subjects affected / exposed	0 / 497 (0.00%)	2 / 135 (1.48%)	1 / 135 (0.74%)
occurrences all number	0	2	1
Viral infection
subjects affected / exposed	2 / 497 (0.40%)	2 / 135 (1.48%)	1 / 135 (0.74%)
occurrences all number	2	2	2

More information

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Were there any global substantial amendments to the protocol? Yes

19 May 2020

The age of the study subject population was extended to 3 months of age and older. Clinical laboratory tests was updated to provide specific requirements for repeat laboratory assessments for alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, and creatinine in the event of ≥30% increase from baseline value.

Were there any global interruptions to the trial? Yes

Date	Interruption	Restart date
24 Mar 2020	Study recruitment was paused for screening due to the COVID-19 pandemic.	01 Jun 2020

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

Study recruitment was paused for screening due to COVID-19 starting 24 March 2020 and restarted on 01 June 2020. No additional disruptions occurred. As such, the impact to study conduct and study data were limited.

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Clinical trials

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Duration of Flare-Free Maintenance Until Onset of First-Flare During the Double Blind (DB) Period

Primary: Duration of Flare-Free Maintenance Until Onset of First-Flare During the Double Blind (DB) Period

Primary: Number of Subjects With Treatment Emergent Adverse Events (TEAEs)

Primary: Number of Subjects With Treatment Emergent Adverse Events (TEAEs)

Secondary: Number of Flare-Free Days During the DB Period

Secondary: Number of Flare-Free Days During the DB Period

Secondary: Number of Flares During the DB Period

Secondary: Number of Flares During the DB Period

Secondary: Duration of Pruritus Response Maintenance Until Onset of First Flare During the DB Period

Secondary: Duration of Pruritus Response Maintenance Until Onset of First Flare During the DB Period

Secondary: Duration of Maintenance of Greater Than or Equal to (>=) 50% Reduction in Eczema Area and Severity Index (EASI) Total Score Until Onset of First Flare During the DB Period

Secondary: Duration of Maintenance of Greater Than or Equal to (>=) 50% Reduction in Eczema Area and Severity Index (EASI) Total Score Until Onset of First Flare During the DB Period

Secondary: Duration of Maintenance of Dermatology Life Quality Index (DLQI) Response Until Onset of First Flare During the DB Period

Secondary: Duration of Maintenance of Dermatology Life Quality Index (DLQI) Response Until Onset of First Flare During the DB Period

Secondary: Duration of Maintenance of Patient Oriented Eczema Measure (POEM) Response Until Onset of First Flare During the DB Period

Secondary: Duration of Maintenance of Patient Oriented Eczema Measure (POEM) Response Until Onset of First Flare During the DB Period

Secondary: Investigator's Static Global Assessment (ISGA) Score for the First Flare Period

Secondary: Investigator's Static Global Assessment (ISGA) Score for the First Flare Period

Secondary: EASI Score for the First Flare Period

Secondary: EASI Score for the First Flare Period

Secondary: Duration (Days) of Flare Period

Secondary: Duration (Days) of Flare Period

Secondary: Percent Change From Baseline in EASI Scores: OL Run-in Period

Secondary: Percent Change From Baseline in EASI Scores: OL Run-in Period

Secondary: Percent Change From Baseline in EASI Scores: DB Period

Secondary: Percent Change From Baseline in EASI Scores: DB Period

Secondary: Percent Change From Baseline in EASI Scores: First Flare Treatment Period

Secondary: Percent Change From Baseline in EASI Scores: First Flare Treatment Period

Secondary: Percent Change From Baseline in EASI Scores: First Flare Free Period

Secondary: Percent Change From Baseline in EASI Scores: First Flare Free Period

Secondary: Change From Baseline in ISGA Scores for OL run-in Period

Secondary: Change From Baseline in ISGA Scores for OL run-in Period

Secondary: Change From Baseline in ISGA Scores for DB Period

Secondary: Change From Baseline in ISGA Scores for DB Period

Secondary: Change From Baseline in ISGA Scores for First Flare Free Period

Secondary: Change From Baseline in ISGA Scores for First Flare Free Period

Secondary: Change From Baseline in ISGA Scores for First Flare Treatment Period

Secondary: Change From Baseline in ISGA Scores for First Flare Treatment Period

Secondary: Change from Baseline in Treatable Percent Body Surface Area (% BSA): OL Run-in Period

Secondary: Change from Baseline in Treatable Percent Body Surface Area (% BSA): OL Run-in Period

Secondary: Change from Baseline in Treatable %BSA: DB Period

Secondary: Change from Baseline in Treatable %BSA: DB Period

Secondary: Change from Baseline in Treatable %BSA: First Flare Free Period

Secondary: Change from Baseline in Treatable %BSA: First Flare Free Period

Secondary: Change from Baseline in Treatable %BSA: First Flare Period

Secondary: Change from Baseline in Treatable %BSA: First Flare Period

Secondary: Change from Baseline in Most Commonly Affected Atopic Dermatitis (AD) % BSA: DB Period

Secondary: Change from Baseline in Most Commonly Affected Atopic Dermatitis (AD) % BSA: DB Period

Secondary: Night Time Itch Score: OL Run-in Period

Secondary: Night Time Itch Score: OL Run-in Period

Secondary: Night Time Itch Score: DB Period

Secondary: Night Time Itch Score: DB Period

Secondary: Night Time Itch Score: First Flare Period

Secondary: Night Time Itch Score: First Flare Period

Secondary: Night Time Itch Score: First Flare Free Period

Secondary: Night Time Itch Score: First Flare Free Period

Secondary: AD Skin Pain Scores: OL Run-in Period

Secondary: AD Skin Pain Scores: OL Run-in Period

Secondary: AD Skin Pain Scores: DB Period

Secondary: AD Skin Pain Scores: DB Period

Secondary: AD Skin Pain Scores: First Flare Period

Secondary: AD Skin Pain Scores: First Flare Period

Secondary: AD Skin Pain Scores: First Flare Free Period

Secondary: AD Skin Pain Scores: First Flare Free Period

Secondary: Patient/Observer Global Impression of Severity Score: OL Run-in Period

Secondary: Patient/Observer Global Impression of Severity Score: OL Run-in Period

Secondary: Patient/Observer Global Impression of Severity Score: DB Period

Secondary: Patient/Observer Global Impression of Severity Score: DB Period

Secondary: Patient/Observer Global Impression of Severity Score: First Flare Period

Secondary: Patient/Observer Global Impression of Severity Score: First Flare Period

Secondary: Patient/Observer Global Impression of Severity Score: First Flare Free Period