Download PDF

Clinical Trial Results:
Open-label Exploratory Study to Evaluate the Effect of Dupilumab on Skin Barrier Function in Pediatric Patients with Moderate to Severe Atopic Dermatitis

Summary
EudraCT number	2020-001518-40
Trial protocol	GB
Global end of trial date	30 Nov 2022

Results information
Results version number	v1(current)
This version publication date	12 Jun 2023
First version publication date	12 Jun 2023
Other versions

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

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

LPS16764

ISRCTN number

US NCT number

NCT04718870

WHO universal trial number (UTN)

U1111-1255-4378

Other trial identifiers

IND number: 107969, Study name: PELISTAD

Sponsor organisation name

Sanofi aventis recherche & développement

Sponsor organisation address

1 avenue Pierre Brossolette, Chilly-Mazarin Cedex, France, 91380

Public contact

Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.com

Scientific contact

Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.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?

Yes

Analysis stage

Final

Date of interim/final analysis

23 Dec 2022

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

30 Nov 2022

Was the trial ended prematurely?

Main objective of the trial

Evaluate changes in skin barrier function with transepidermal water loss (TEWL) assessed after skin tape stripping (STS) in predefined lesional skin in pediatric subjects with moderate to severe atopic dermatitis (AD) treated with dupilumab.

Protection of trial subjects

The study was conducted by investigators experienced in the treatment of paediatric subjects. The parent(s) or guardian(s) as well as the children were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time. In addition to the consent form for the parent(s)/guardian(s), an assent form in child-appropriate language was provided and explained to the child. Repeated invasive procedures were minimised. The number of blood samples as well as the amount of blood drawn were adjusted according to age and weight. A topical anesthesia may have been used to minimise distress and discomfort.

Background therapy

Evidence for comparator

Actual start date of recruitment

19 Feb 2021

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

United States: 18

Country: Number of subjects enrolled

United Kingdom: 23

Worldwide total number of subjects

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)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

Top of page

Recruitment details

Study was conducted at 3 active sites in the United States and United Kingdom. A total of 43 subjects were screened between 19 Feb 2021 and 12 May 2022, out of which 41 were enrolled and 2 were screen failures due to not meeting inclusion criteria.

Screening details

Healthy volunteer’s cohort received no treatment and was considered as a reference comparator group.

Period 1 title

Overall study (overall period)

Is this the baseline period?

Yes

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Healthy Volunteers

Arm description

Healthy volunteers with age, gender, location of targeted skin lesion area and study site matched to selected atopic dermatitis (AD) subjects, received no treatment, but were monitored in similar way as AD subjects.

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

Atopic Dermatitis Subjects

Arm description

Pediatric subjects with moderate-to-severe AD and with baseline body weight more than or equal to (>=) 15 kilograms (kg) and less than (<) 30 kg received a subcutaneous (SC) loading dose of dupilumab 600 milligrams (mg) (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection every 4 week (Q4W), from Week 4 to Week 12. Pediatric subjects with body weight >= 30 kg and <60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection every 2 week (Q2W), from Week 2 to Week 14.

Arm type

Experimental

Investigational medicinal product name

Dupilumab

Investigational medicinal product code

SAR231893

Other name

Dupixent®, REGN668

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Dupilumab loading dose of 600 mg (body weight >= 15 kg and < 30 kg) and 400 mg (body weight >=30 kg and < 60 kg) SC injections followed by subsequent doses of dupilumab 300 mg SC injection every 4 weeks and dupilumab 200 mg every 2 weeks respectively.

Number of subjects in period 1	Healthy Volunteers	Atopic Dermatitis Subjects
Started	18	23
Completed	18	23

Baseline characteristics

Top of page

Reporting group title

Healthy Volunteers

Reporting group description

Reporting group title

Atopic Dermatitis Subjects

Reporting group description

Reporting group values	Healthy Volunteers	Atopic Dermatitis Subjects	Total
Number of subjects	18	23	41
Age categorical
Units: Subjects
Age continuous
Units: years
arithmetic mean (standard deviation)	8.2 ± 1.8	7.8 ± 1.6	-
Gender categorical
Units: Subjects
Female	8	8	16
Male	10	15	25
Race
Units: Subjects
White	9	16	25
Black or african american	2	2	4
Asian	6	3	9
Multiple	0	1	1
Not reported	1	1	2

End points

Top of page

Reporting group title

Healthy Volunteers

Reporting group description

Reporting group title

Atopic Dermatitis Subjects

Reporting group description

Primary: Percent Change From Baseline in Transepidermal Water Loss (TEWL) After 5 Skin Tape Stripping (STS) on Lesional Skin (LS) in AD Subjects at Week 16

Top of page

End point title

Percent Change From Baseline in Transepidermal Water Loss (TEWL) After 5 Skin Tape Stripping (STS) on Lesional Skin (LS) in AD Subjects at Week 16 ^[1] ^[2]

End point description

TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterise skin barrier function (SBF). With STS, the uppermost layers of skin are peeled away using adhesive discs. LS areas for TEWL assessment and STS was identified at baseline (predefined skin area). Within predefined LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS & after 5, 10, 15 & 20 STS on pre-defined LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on 1st spot. Percent change from baseline at Week 16 in TEWL after 5 STS on LS (1st spot) in AD subjects were reported in this endpoint. mITT population: AD subjects, had at least 1 dose of IMP & healthy volunteers, had at least 1 TEWL/STS. If prohibited therapies used, only visits prior to rescue therapy were considered. Number of subjects analysed = subjects with available data for this endpoint.

End point type

Primary

End point timeframe

Baseline, Week 16

Notes
[1] - 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: Statistical analysis is not presented due to normality issues with the repeated measure mixed model.
[2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this endpoint is reported for the applicable arm in the study.

End point values	Atopic Dermatitis Subjects
Number of subjects analysed	18
Units: percent change
arithmetic mean (standard deviation)	-38.5633 ± 27.1211

No statistical analyses for this end point

Secondary: Percent Change From Baseline in TEWL After 20 STS on Lesional Skin in AD Subjects at Week 16

Top of page

End point title

Percent Change From Baseline in TEWL After 20 STS on Lesional Skin in AD Subjects at Week 16 ^[3]

End point description

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterise SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 20 STS on LS (first spot) in AD subjects were reported in this endpoint. Analysed on modified intent-to-treat (mITT) population. Here, 'number of subjects analysed' = subjects with available data for this endpoint.

End point type

Secondary

End point timeframe

Baseline, Week 16

Notes
[3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this endpoint is reported for the applicable arm in the study.

End point values	Atopic Dermatitis Subjects
Number of subjects analysed	17
Units: percent change
arithmetic mean (standard deviation)	-33.1336 ± 28.1613

No statistical analyses for this end point

Secondary: Absolute Change From Baseline in TEWL After 20 STS on Lesional Skin in AD Subjects at Week 16

Top of page

End point title

Absolute Change From Baseline in TEWL After 20 STS on Lesional Skin in AD Subjects at Week 16 ^[4]

End point description

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that was used to characterise SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified timepoints. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 20 STS on LS (first spot) in AD subjects were reported in this endpoint. Analysis was performed on mITT population. Here, 'number of subjects analysed' = subjects with available data for this endpoint.

End point type

Secondary

End point timeframe

Baseline, Week 16

Notes
[4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this endpoint is reported for the applicable arm in the study.

End point values	Atopic Dermatitis Subjects
Number of subjects analysed	17
Units: grams per square metre per hour
arithmetic mean (standard deviation)	-35.6671 ± 31.2267

No statistical analyses for this end point

Secondary: Percent Change From Baseline in TEWL After 20 STS on Non-lesional Skin (Non-LS) in AD Subjects at Week 16

Top of page

End point title

Percent Change From Baseline in TEWL After 20 STS on Non-lesional Skin (Non-LS) in AD Subjects at Week 16 ^[5]

End point description

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterise SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified timepoints. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 20 STS on non-LS (first spot) in AD subjects were reported in this endpoint. Analysed on mITT population. Here, 'number of subjects analysed' = subjects with available data for this endpoint.

End point type

Secondary

End point timeframe

Baseline, Week 16

Notes
[5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this endpoint is reported for the applicable arm in the study.

End point values	Atopic Dermatitis Subjects
Number of subjects analysed	17
Units: percent change
arithmetic mean (standard deviation)	-6.1452 ± 67.9496

No statistical analyses for this end point

Secondary: Absolute Change From Baseline in TEWL After 20 STS on Non-lesional Skin in AD Subjects at Week 16

Top of page

End point title

Absolute Change From Baseline in TEWL After 20 STS on Non-lesional Skin in AD Subjects at Week 16 ^[6]

End point description

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterise SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified timepoints. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 20 STS on non-LS (first spot) in AD subjects were reported in this endpoint. Analysis was performed on mITT population. Here, 'number of subjects analysed' = subjects with available data for this endpoint.

End point type

Secondary

End point timeframe

Baseline, Week 16

Notes
[6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this endpoint is reported for the applicable arm in the study.

End point values	Atopic Dermatitis Subjects
Number of subjects analysed	17
Units: grams per square metre per hour
arithmetic mean (standard deviation)	-13.6682 ± 33.3065

No statistical analyses for this end point

Secondary: Percent Change From Baseline in TEWL After 20 STS on Normal Skin in Healthy Volunteers at Week 16

Top of page

End point title

Percent Change From Baseline in TEWL After 20 STS on Normal Skin in Healthy Volunteers at Week 16 ^[7]

End point description

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterise SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 20 STS on normal skin (first spot) in healthy volunteers were reported in this endpoint. Analysis was performed on mITT population. Here, 'number of subjects analysed' = subjects with available data for this endpoint.

End point type

Secondary

End point timeframe

Baseline, Week 16

Notes
[7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this endpoint is reported for the applicable arm in the study.

End point values	Healthy Volunteers
Number of subjects analysed	11
Units: percent change
arithmetic mean (standard deviation)	13.2578 ± 64.3880

No statistical analyses for this end point

Secondary: Absolute Change From Baseline in TEWL After 20 STS on Normal Skin in Healthy Volunteers at Week 16

Top of page

End point title

Absolute Change From Baseline in TEWL After 20 STS on Normal Skin in Healthy Volunteers at Week 16 ^[8]

End point description

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterise SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 20 STS on normal skin (first spot) in healthy volunteers were reported in this endpoint. Analysis was performed on mITT population. Here, 'number of subjects analysed' = subjects with available data for this endpoint.

End point type

Secondary

End point timeframe

Baseline, Week 16

Notes
[8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this endpoint is reported for the applicable arm in the study.

End point values	Healthy Volunteers
Number of subjects analysed	11
Units: grams per square metre per hour
arithmetic mean (standard deviation)	5.9327 ± 32.0123

No statistical analyses for this end point

Secondary: Percent Change From Baseline in TEWL After 15 STS on Lesional Skin in AD Subjects at Week 16

Top of page

End point title

Percent Change From Baseline in TEWL After 15 STS on Lesional Skin in AD Subjects at Week 16 ^[9]

End point description

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterise SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified timepoints. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 15 STS on LS (first spot) in AD subjects were reported in this endpoint. Analysis was performed on mITT population. Here, 'number of subjects analysed' = subjects with available data for this endpoint.

End point type

Secondary

End point timeframe

Baseline, Week 16

Notes
[9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this endpoint is reported for the applicable arm in the study.

End point values	Atopic Dermatitis Subjects
Number of subjects analysed	18
Units: percent change
arithmetic mean (standard deviation)	-33.3119 ± 32.7125

No statistical analyses for this end point

Secondary: Absolute Change From Baseline in TEWL After 15 STS on Lesional Skin in AD Subjects at Week 16

Top of page

End point title

Absolute Change From Baseline in TEWL After 15 STS on Lesional Skin in AD Subjects at Week 16 ^[10]

End point description

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterise SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified timepoints. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 15 STS on LS (first spot) in AD subjects were reported in this endpoint. Analysis was performed on mITT population. Here, 'number of subjects analysed' = subjects with available data for this endpoint.

End point type

Secondary

End point timeframe

Baseline, Week 16

Notes
[10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this endpoint is reported for the applicable arm in the study.

End point values	Atopic Dermatitis Subjects
Number of subjects analysed	18
Units: grams per square metre per hour
arithmetic mean (standard deviation)	-33.4028 ± 31.1957

No statistical analyses for this end point

Secondary: Percent Change From Baseline in TEWL After 15 STS on Non-lesional Skin in AD Subjects at Week 16

Top of page

End point title

Percent Change From Baseline in TEWL After 15 STS on Non-lesional Skin in AD Subjects at Week 16 ^[11]

End point description

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterise SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified timepoints. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 15 STS on non-LS (first spot) in AD subjects were reported in this endpoint. Analysis was performed on mITT population. Here, 'number of subjects analysed' = subjects with available data for this endpoint.

End point type

Secondary

End point timeframe

Baseline, Week 16

Notes
[11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this endpoint is reported for the applicable arm in the study.

End point values	Atopic Dermatitis Subjects
Number of subjects analysed	17
Units: percent change
arithmetic mean (standard deviation)	-7.6067 ± 54.7945

No statistical analyses for this end point

Secondary: Absolute Change From Baseline in TEWL After 15 STS on Non-lesional Skin in AD Subjects at Week 16

Top of page

End point title

Absolute Change From Baseline in TEWL After 15 STS on Non-lesional Skin in AD Subjects at Week 16 ^[12]

End point description

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterise SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified timepoints. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 15 STS on non-LS (first spot) in AD subjects were reported in this endpoint. Analysis was performed on mITT population. Here, 'number of subjects analysed' = subjects with available data for this endpoint.

End point type

Secondary

End point timeframe

Baseline, Week 16

Notes
[12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this endpoint is reported for the applicable arm in the study.

End point values	Atopic Dermatitis Subjects
Number of subjects analysed	17
Units: grams per square metre per hour
arithmetic mean (standard deviation)	-12.6576 ± 30.0412

No statistical analyses for this end point

Secondary: Percent Change From Baseline in TEWL After 15 STS on Normal Skin in Healthy Volunteers at Week 16

Top of page

End point title

Percent Change From Baseline in TEWL After 15 STS on Normal Skin in Healthy Volunteers at Week 16 ^[13]

End point description

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterise SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 15 STS on normal skin (first spot) in healthy volunteers were reported in this endpoint. Analysis was performed on mITT population. Here, 'number of subjects analysed' = subjects with available data for this endpoint.

End point type

Secondary

End point timeframe

Baseline, Week 16

Notes
[13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this endpoint is reported for the applicable arm in the study.

End point values	Healthy Volunteers
Number of subjects analysed	11
Units: percent change
arithmetic mean (standard deviation)	4.5364 ± 42.7525

No statistical analyses for this end point

Secondary: Absolute Change From Baseline in TEWL After 15 STS on Normal Skin in Healthy Volunteers at Week 16

Top of page

End point title

Absolute Change From Baseline in TEWL After 15 STS on Normal Skin in Healthy Volunteers at Week 16 ^[14]

End point description

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterise SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 15 STS on normal skin (first spot) in healthy volunteers were reported in this endpoint. Analysis was performed on mITT population. Here, 'number of subjects analysed' = subjects with available data for this endpoint.

End point type

Secondary

End point timeframe

Baseline, Week 16

Notes
[14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this endpoint is reported for the applicable arm in the study.

End point values	Healthy Volunteers
Number of subjects analysed	11
Units: grams per square metre per hour
arithmetic mean (standard deviation)	0.1082 ± 17.5865

No statistical analyses for this end point

Secondary: Percent Change From Baseline in TEWL After 10 STS on Lesional Skin in AD Subjects at Week 16

Top of page

End point title

Percent Change From Baseline in TEWL After 10 STS on Lesional Skin in AD Subjects at Week 16 ^[15]

End point description

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterise SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified timepoints. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 10 STS on LS (first spot) in AD subjects were reported in this endpoint. Analysis was performed on mITT population. Here, 'number of subjects analysed' = subjects with available data for this endpoint.

End point type

Secondary

End point timeframe

Baseline, Week 16

Notes
[15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this endpoint is reported for the applicable arm in the study.

End point values	Atopic Dermatitis Subjects
Number of subjects analysed	17
Units: percent change
arithmetic mean (standard deviation)	-34.7741 ± 31.0541

No statistical analyses for this end point

Secondary: Absolute Change From Baseline in TEWL After 10 STS on Lesional Skin in AD Subjects at Week 16

Top of page

End point title

Absolute Change From Baseline in TEWL After 10 STS on Lesional Skin in AD Subjects at Week 16 ^[16]

End point description

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterise SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified timepoints. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 10 STS on LS (first spot) in AD subjects were reported in this endpoint. Analysis was performed on mITT population. Here, 'number of subjects analysed' = subjects with available data for this endpoint.

End point type

Secondary

End point timeframe

Baseline, Week 16

Notes
[16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this endpoint is reported for the applicable arm in the study.

End point values	Atopic Dermatitis Subjects
Number of subjects analysed	17
Units: grams per square metre per hour
arithmetic mean (standard deviation)	-33.1024 ± 36.2286

No statistical analyses for this end point

Secondary: Percent Change From Baseline in TEWL After 10 STS on Non-lesional Skin in AD Subjects at Week 16

Top of page

End point title

Percent Change From Baseline in TEWL After 10 STS on Non-lesional Skin in AD Subjects at Week 16 ^[17]

End point description

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterise SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified timepoints. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 10 STS on non-LS (first spot) in AD subjects were reported in this endpoint. Analysis was performed on mITT population. Here, 'number of subjects analysed' = subjects with available data for this endpoint.

End point type

Secondary

End point timeframe

Baseline, Week 16

Notes
[17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this endpoint is reported for the applicable arm in the study.

End point values	Atopic Dermatitis Subjects
Number of subjects analysed	17
Units: percent change
arithmetic mean (standard deviation)	-3.8193 ± 74.6263

No statistical analyses for this end point

Secondary: Absolute Change From Baseline in TEWL After 10 STS on Non-lesional Skin in AD Subjects at Week 16

Top of page

End point title

Absolute Change From Baseline in TEWL After 10 STS on Non-lesional Skin in AD Subjects at Week 16 ^[18]

End point description

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterise SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified timepoints. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 10 STS on non-LS (first spot) in AD subjects were reported in this endpoint. Analysis was performed on mITT population. Here, 'number of subjects analysed' = subjects with available data for this endpoint.

End point type

Secondary

End point timeframe

Baseline, Week 16

Notes
[18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this endpoint is reported for the applicable arm in the study.

End point values	Atopic Dermatitis Subjects
Number of subjects analysed	17
Units: grams per square metre per hour
arithmetic mean (standard deviation)	-10.9488 ± 31.1300

No statistical analyses for this end point

Secondary: Percent Change From Baseline in TEWL After 10 STS on Normal Skin in Healthy Volunteers at Week 16

Top of page

End point title

Percent Change From Baseline in TEWL After 10 STS on Normal Skin in Healthy Volunteers at Week 16 ^[19]

End point description

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterise SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 10 STS on normal skin (first spot) in healthy volunteers were reported in this endpoint. Analysis was performed on mITT population. Here, 'number of subjects analysed' = subjects with available data for this endpoint.

End point type

Secondary

End point timeframe

Baseline, Week 16

Notes
[19] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this endpoint is reported for the applicable arm in the study.

End point values	Healthy Volunteers
Number of subjects analysed	11
Units: percent change
arithmetic mean (standard deviation)	0.7091 ± 25.0615

No statistical analyses for this end point

Secondary: Absolute Change From Baseline in TEWL After 10 STS on Normal Skin in Healthy Volunteers at Week 16

Top of page

End point title

Absolute Change From Baseline in TEWL After 10 STS on Normal Skin in Healthy Volunteers at Week 16 ^[20]

End point description

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterise SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 10 STS on normal skin (first spot) in healthy volunteers were reported in this endpoint. Analysis was performed on mITT population. Here, 'number of subjects analysed' = subjects with available data for this endpoint.

End point type

Secondary

End point timeframe

Baseline, Week 16

Notes
[20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this endpoint is reported for the applicable arm in the study.

End point values	Healthy Volunteers
Number of subjects analysed	11
Units: grams per square metre per hour
arithmetic mean (standard deviation)	-1.3482 ± 6.6778

No statistical analyses for this end point

Secondary: Percent Change From Baseline in TEWL After 5 STS on Non-lesional Skin in AD Subjects at Week 16

Top of page

End point title

Percent Change From Baseline in TEWL After 5 STS on Non-lesional Skin in AD Subjects at Week 16 ^[21]

End point description

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterise SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 5 STS on non-LS (first spot) in AD subjects were reported in this endpoint. Analysis was performed on mITT population. Here, 'number of subjects analysed' = subjects with available data for this endpoint.

End point type

Secondary

End point timeframe

Baseline, Week 16

Notes
[21] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this endpoint is reported for the applicable arm in the study.

End point values	Atopic Dermatitis Subjects
Number of subjects analysed	17
Units: percent change
arithmetic mean (standard deviation)	-4.8842 ± 70.5670

No statistical analyses for this end point

Secondary: Absolute Change From Baseline in TEWL After 5 STS on Non-lesional Skin in AD Subjects at Week 16

Top of page

End point title

Absolute Change From Baseline in TEWL After 5 STS on Non-lesional Skin in AD Subjects at Week 16 ^[22]

End point description

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterise SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 5 STS on non-LS (first spot) in AD subjects were reported in this endpoint. Analysis was performed on mITT population. Here, 'number of subjects analysed' = subjects with available data for this endpoint.

End point type

Secondary

End point timeframe

Baseline, Week 16

Notes
[22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this endpoint is reported for the applicable arm in the study.

End point values	Atopic Dermatitis Subjects
Number of subjects analysed	17
Units: grams per square metre per hour
arithmetic mean (standard deviation)	-9.0771 ± 21.3022

No statistical analyses for this end point

Secondary: Percent Change From Baseline in TEWL After 5 STS on Normal Skin in Healthy Volunteers at Week 16

Top of page

End point title

Percent Change From Baseline in TEWL After 5 STS on Normal Skin in Healthy Volunteers at Week 16 ^[23]

End point description

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterise SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 5 STS on normal skin (first spot) in healthy volunteers were reported in this endpoint. Analysis was performed on mITT population. Here, 'number of subjects analysed' = subjects with available data for this endpoint.

End point type

Secondary

End point timeframe

Baseline, Week 16

Notes
[23] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this endpoint is reported for the applicable arm in the study.

End point values	Healthy Volunteers
Number of subjects analysed	11
Units: percent change
arithmetic mean (standard deviation)	1.4464 ± 26.7257

No statistical analyses for this end point

Secondary: Absolute Change From Baseline in TEWL After 5 STS on Normal Skin in Healthy Volunteers at Week 16

Top of page

End point title

Absolute Change From Baseline in TEWL After 5 STS on Normal Skin in Healthy Volunteers at Week 16 ^[24]

End point description

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterise SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 5 STS on normal skin (first spot) in healthy volunteers were reported in this endpoint. Analysis was performed on mITT population. Here, 'number of subjects analysed' = subjects with available data for this endpoint.

End point type

Secondary

End point timeframe

Baseline, Week 16

Notes
[24] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this endpoint is reported for the applicable arm in the study.

End point values	Healthy Volunteers
Number of subjects analysed	11
Units: grams per square metre per hour
arithmetic mean (standard deviation)	-1.0255 ± 4.3657

No statistical analyses for this end point

Secondary: Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Subjects at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197

Top of page

End point title

Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Subjects at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 ^[25]

End point description

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterise SBF. LS areas for TEWL assessment were identified at baseline (predefined skin area). Within predefined LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS on pre-defined LS areas at specified time points. At each visit, before STS, all 3 spots were assessed. Percent change from baseline at specified time points in TEWL before STS on LS (at each spot) in AD subjects were reported in this endpoint. Analysis was performed on mITT population. Here, 'n' = subjects with available data for each specified category.

End point type

Secondary

End point timeframe

Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197

Notes
[25] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this endpoint is reported for the applicable arm in the study.

End point values	Atopic Dermatitis Subjects
Number of subjects analysed	23
Units: percent change
arithmetic mean (standard deviation)
Day 8 - Spot 1 (n=22)	-7.1596 ± 36.6637
Day 8 - Spot 2 (n=23)	-6.3439 ± 33.8145
Day 8 - Spot 3 (n=23)	-7.0747 ± 28.3554
Day 15 - Spot 1 (n=22)	-15.3096 ± 45.6163
Day 15 - Spot 2 (n=22)	-11.0740 ± 35.5483
Day 15 - Spot 3 (n=22)	-8.1780 ± 44.9382
Day 22 - Spot 1 (n=21)	-30.3070 ± 33.6643
Day 22 - Spot 2 (n=21)	-29.1730 ± 31.7167
Day 22 - Spot 3 (n=21)	-27.0015 ± 25.8528
Day 29 - Spot 1 (n=20)	-37.8349 ± 24.7709
Day 29 - Spot 2 (n=20)	-33.0139 ± 27.8560
Day 29 - Spot 3 (n=20)	-32.7080 ± 28.8445
Day 43 - Spot 1 (n=17)	-37.8675 ± 29.0275
Day 43 - Spot 2 (n=17)	-36.1625 ± 28.9829
Day 43 - Spot 3 (n=17)	-32.9996 ± 33.2028
Day 57 - Spot 1 (n=19)	-38.2449 ± 40.0558
Day 57 - Spot 2 (n=19)	-39.3104 ± 27.6888
Day 57 - Spot 3 (n=19)	-35.8992 ± 27.9526
Day 85 - Spot 1 (n=18)	-45.6060 ± 23.2839
Day 85 - Spot 2 (n=18)	-40.8609 ± 30.8002
Day 85 - Spot 3 (n=18)	-41.1371 ± 24.5842
Day 113 - Spot 1 (n=18)	-36.0863 ± 33.7259
Day 113 - Spot 2 (n=18)	-37.4815 ± 30.8507
Day 113 - Spot 3 (n=18)	-32.3491 ± 29.2966
Day 155 - Spot 1 (n=14)	-40.9536 ± 30.9966
Day 155 - Spot 2 (n=14)	-20.8463 ± 50.6518
Day 155 - Spot 3 (n=14)	-31.3185 ± 42.0614
Day 197 - Spot 1 (n=15)	-35.2305 ± 45.8818
Day 197 - Spot 2 (n=15)	-30.3358 ± 48.3028
Day 197 - Spot 3 (n=15)	-36.5267 ± 37.7230

No statistical analyses for this end point

Secondary: Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Subjects at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197

Top of page

End point title

Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Subjects at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 ^[26]

End point description

TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterise SBF. LS areas for TEWL assessment were identified at baseline (predefined skin area). Within predefined LS and areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS on pre-defined LS areas at specified time points. At each visit, before STS, all 3 spots were assessed. Absolute change from baseline at specified time points in TEWL before STS on LS (at each spot) in AD subjects were reported in this endpoint. Analysis was performed on mITT population. Here, 'n' = subjects with available data for each specified category.

End point type

Secondary

End point timeframe

Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197

Notes
[26] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this endpoint is reported for the applicable arm in the study.

End point values	Atopic Dermatitis Subjects
Number of subjects analysed	23
Units: grams per square metre per hour
arithmetic mean (standard deviation)
Day 8 - Spot 1 (n=22)	-9.3486 ± 21.2256
Day 8 - Spot 2 (n=23)	-6.0491 ± 17.5810
Day 8 - Spot 3 (n=23)	-3.1965 ± 14.4640
Day 15 - Spot 1 (n=22)	-15.4336 ± 25.0975
Day 15 - Spot 2 (n=22)	-9.8073 ± 19.7385
Day 15 - Spot 3 (n=22)	-7.6682 ± 21.9239
Day 22 - Spot 1 (n=21)	-23.0157 ± 26.8847
Day 22 - Spot 2 (n=21)	-20.7186 ± 23.4149
Day 22 - Spot 3 (n=21)	-15.6557 ± 20.1212
Day 29 - Spot 1 (n=20)	-23.9585 ± 21.7106
Day 29 - Spot 2 (n=20)	-21.2010 ± 21.2593
Day 29 - Spot 3 (n=20)	-17.9170 ± 19.7310
Day 43 - Spot 1 (n=17)	-27.0535 ± 28.0249
Day 43 - Spot 2 (n=17)	-24.5188 ± 25.6684
Day 43 - Spot 3 (n=17)	-20.7018 ± 22.5936
Day 57 - Spot 1 (n=19)	-25.1221 ± 27.0210
Day 57 - Spot 2 (n=19)	-24.2358 ± 24.6028
Day 57 - Spot 3 (n=19)	-20.3379 ± 20.3751
Day 85 - Spot 1 (n=18)	-29.1917 ± 24.3114
Day 85 - Spot 2 (n=18)	-24.4494 ± 24.2054
Day 85 - Spot 3 (n=18)	-23.1056 ± 20.4692
Day 113 - Spot 1 (n=18)	-24.6678 ± 27.8013
Day 113 - Spot 2 (n=18)	-23.2878 ± 26.5670
Day 113 - Spot 3 (n=18)	-17.9028 ± 22.2483
Day 155 - Spot 1 (n=14)	-28.2564 ± 29.2212
Day 155 - Spot 2 (n=14)	-18.7786 ± 31.4917
Day 155 - Spot 3 (n=14)	-19.8921 ± 27.8520
Day 197 - Spot 1 (n=15)	-27.4493 ± 33.7080
Day 197 - Spot 2 (n=15)	-22.5607 ± 31.7696
Day 197 - Spot 3 (n=15)	-22.0860 ± 27.1286

No statistical analyses for this end point

Secondary: Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Subjects at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197

Top of page

End point title

Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Subjects at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 ^[27]

End point description

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterise SBF. Non-LS areas for TEWL assessment were identified at baseline (predefined skin area). Within predefined non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS on pre-defined non-LS areas at specified time points. At each visit, before STS, all 3 spots were assessed. Percent change from baseline at specified time points in TEWL before STS on non-LS (at each spot) in AD subjects were reported in this endpoint. Analysis was performed on mITT population. Here, 'n' = subjects with available data for each specified category.

End point type

Secondary

End point timeframe

Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197

Notes
[27] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this endpoint is reported for the applicable arm in the study.

End point values	Atopic Dermatitis Subjects
Number of subjects analysed	23
Units: percent change
arithmetic mean (standard deviation)
Day 8 - Spot 1 (n=23)	41.0825 ± 91.3744
Day 8 - Spot 2 (n=21)	13.5236 ± 49.3733
Day 8 - Spot 3 (n=23)	9.7943 ± 43.9272
Day 15 - Spot 1 (n=22)	19.0612 ± 58.1703
Day 15 - Spot 2 (n=21)	9.6866 ± 52.6831
Day 15 - Spot 3 (n=21)	13.2574 ± 55.8095
Day 22 - Spot 1 (n=21)	-3.9277 ± 35.9880
Day 22 - Spot 2 (n=20)	8.9306 ± 70.2617
Day 22 - Spot 3 (n=21)	0.4973 ± 49.5636
Day 29 - Spot 1 (n=20)	-8.9585 ± 39.0443
Day 29 - Spot 2 (n=19)	-10.5728 ± 35.2672
Day 29 - Spot 3 (n=20)	-13.0407 ± 44.5264
Day 43 - Spot 1 (n=17)	-15.6919 ± 29.7995
Day 43 - Spot 2 (n=16)	-21.6885 ± 30.1255
Day 43 - Spot 3 (n=17)	-16.2025 ± 42.7984
Day 57 - Spot 1 (n=19)	-24.5008 ± 26.9801
Day 57 - Spot 2 (n=18)	-27.6040 ± 23.0969
Day 57 - Spot 3 (n=19)	-25.7321 ± 33.1310
Day 85 - Spot 1 (n=18)	-21.9316 ± 34.3620
Day 85 - Spot 2 (n=17)	-16.7008 ± 62.4384
Day 85 - Spot 3 (n=18)	-29.2721 ± 40.0673
Day 113 - Spot 1 (n=17)	-20.4359 ± 42.6948
Day 113 - Spot 2 (n=16)	-23.1303 ± 41.2717
Day 113 - Spot 3 (n=17)	-27.4981 ± 33.5326
Day 155 - Spot 1 (n=14)	-6.7535 ± 73.4261
Day 155 - Spot 2 (n=13)	-16.3903 ± 41.9864
Day 155 - Spot 3 (n=14)	-19.3970 ± 46.5302
Day 197 - Spot 1 (n=16)	-23.3812 ± 39.5978
Day 197 - Spot 2 (n=15)	-27.3104 ± 32.8267
Day 197 - Spot 3 (n=16)	-22.1813 ± 40.5124

No statistical analyses for this end point

Secondary: Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Subjects at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197

Top of page

End point title

Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Subjects at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 ^[28]

End point description

TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterise SBF. Non-LS areas for TEWL assessment were identified at baseline (predefined skin area). Within predefined non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS on pre-defined non-LS areas at specified time points. At each visit, before STS, all 3 spots were assessed. Absolute change from baseline at specified time points in TEWL before STS on non-LS (at each spot) in AD subjects were reported in this endpoint. Analysis was performed on mITT population. Here, 'n' = subjects with available data for each specified category.

End point type

Secondary

End point timeframe

Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197

Notes
[28] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this endpoint is reported for the applicable arm in the study.

End point values	Atopic Dermatitis Subjects
Number of subjects analysed	23
Units: grams per square metre per hour
arithmetic mean (standard deviation)
Day 8 - Spot 1 (n=23)	4.1752 ± 14.1047
Day 8 - Spot 2 (n=21)	-0.0248 ± 11.8585
Day 8 - Spot 3 (n=23)	-0.3413 ± 9.8571
Day 15 - Spot 1 (n=22)	0.4723 ± 9.7975
Day 15 - Spot 2 (n=21)	-2.6176 ± 13.1001
Day 15 - Spot 3 (n=21)	-1.0171 ± 11.3877
Day 22 - Spot 1 (n=21)	-3.8162 ± 10.3046
Day 22 - Spot 2 (n=20)	-3.5735 ± 16.4593
Day 22 - Spot 3 (n=21)	-5.3314 ± 12.8392
Day 29 - Spot 1 (n=20)	-5.3400 ± 10.8674
Day 29 - Spot 2 (n=19)	-6.7411 ± 13.5999
Day 29 - Spot 3 (n=20)	-9.5905 ± 14.0754
Day 43 - Spot 1 (n=17)	-6.7424 ± 9.7834
Day 43 - Spot 2 (n=16)	-8.8444 ± 12.4876
Day 43 - Spot 3 (n=17)	-10.5600 ± 14.1984
Day 57 - Spot 1 (n=19)	-8.2874 ± 8.5546
Day 57 - Spot 2 (n=18)	-9.7772 ± 11.7879
Day 57 - Spot 3 (n=19)	-11.9179 ± 13.1662
Day 85 - Spot 1 (n=18)	-8.2272 ± 11.6158
Day 85 - Spot 2 (n=17)	-7.6171 ± 16.1511
Day 85 - Spot 3 (n=18)	-13.1811 ± 14.4647
Day 113 - Spot 1 (n=17)	-8.0665 ± 11.9970
Day 113 - Spot 2 (n=16)	-9.2906 ± 13.7202
Day 113 - Spot 3 (n=17)	-11.2776 ± 12.9322
Day 155 - Spot 1 (n=14)	-7.0229 ± 15.4066
Day 155 - Spot 2 (n=13)	-7.0408 ± 12.8562
Day 155 - Spot 3 (n=14)	-10.4414 ± 14.5146
Day 197 - Spot 1 (n=16)	-8.9200 ± 11.3266
Day 197 - Spot 2 (n=15)	-11.2953 ± 15.3452
Day 197 - Spot 3 (n=16)	-11.1625 ± 16.2087

No statistical analyses for this end point

Secondary: Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197

Top of page

End point title

Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 ^[29]

End point description

TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterise SBF. Normal skin areas for TEWL assessment were identified at baseline (predefined skin area). Within predefined normal skin areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS on pre-defined normal skin areas at specified time points. At each visit, before STS, all 3 spots were assessed. Percent change from baseline at specified time points in TEWL before STS on normal skin (at each spot) in healthy volunteers were reported in this endpoint. Analysis was performed on mITT population. Here, 'number of subjects analysed' = subjects with available data for this endpoint and 'n' = subjects with available data for each specified category.

End point type

Secondary

End point timeframe

Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197

Notes
[29] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this endpoint is reported for the applicable arm in the study.

End point values	Healthy Volunteers
Number of subjects analysed	15
Units: percent change
arithmetic mean (standard deviation)
Day 8 - Spot 1 (n=13)	5.0103 ± 39.4170
Day 8 - Spot 2 (n=13)	-8.7688 ± 20.5764
Day 8 - Spot 3 (n=13)	-3.8203 ± 19.5160
Day 15 - Spot 1 (n=14)	1.9837 ± 27.7012
Day 15 - Spot 2 (n=14)	-4.0758 ± 22.1886
Day 15 - Spot 3 (n=14)	-1.7489 ± 21.1652
Day 22 - Spot 1 (n=12)	-2.6655 ± 19.8558
Day 22 - Spot 2 (n=12)	7.5939 ± 22.7859
Day 22 - Spot 3 (n=12)	3.8603 ± 12.1068
Day 29 - Spot 1 (n=13)	-1.7648 ± 21.4820
Day 29 - Spot 2 (n=13)	9.9969 ± 14.4219
Day 29 - Spot 3 (n=13)	8.4098 ± 15.2499
Day 43 - Spot 1 (n=14)	1.4115 ± 27.8012
Day 43 - Spot 2 (n=14)	2.9668 ± 30.1272
Day 43 - Spot 3 (n=14)	13.4093 ± 35.9985
Day 57 - Spot 1 (n=12)	7.6533 ± 24.0747
Day 57 - Spot 2 (n=12)	5.3384 ± 17.9065
Day 57 - Spot 3 (n=12)	12.6926 ± 24.7125
Day 85 - Spot 1 (n=14)	5.2021 ± 23.1397
Day 85 - Spot 2 (n=14)	0.7096 ± 19.5448
Day 85 - Spot 3 (n=14)	5.1021 ± 20.0690
Day 113 - Spot 1 (n=11)	2.6054 ± 26.2241
Day 113 - Spot 2 (n=11)	9.4234 ± 24.1533
Day 113 - Spot 3 (n=11)	17.0905 ± 16.4596
Day 155 - Spot 1 (n=15)	10.3105 ± 52.8138
Day 155 - Spot 2 (n=15)	11.2398 ± 22.7028
Day 155 - Spot 3 (n=15)	11.5842 ± 27.2298
Day 197 - Spot 1 (n=15)	3.3636 ± 26.9400
Day 197 - Spot 2 (n=15)	5.3772 ± 19.9583
Day 197 - Spot 3 (n=15)	12.0900 ± 24.8690

No statistical analyses for this end point

Secondary: Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197

Top of page

End point title

Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 ^[30]

End point description

TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterise SBF. Normal skin areas for TEWL assessment were identified at baseline (predefined skin area). Within predefined normal skin areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS on pre-defined normal skin areas at specified time points. At each visit, before STS, all 3 spots were assessed. Absolute change from baseline at specified time points in TEWL before STS on normal skin (at each spot) in healthy volunteers were reported in this endpoint. Analysis was performed on mITT population. Here, 'number of subjects analysed' = subjects with available data for this endpoint and 'n' = subjects with available data for each specified category.

End point type

Secondary

End point timeframe

Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197

Notes
[30] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this endpoint is reported for the applicable arm in the study.

End point values	Healthy Volunteers
Number of subjects analysed	15
Units: grams per square metre per hour
arithmetic mean (standard deviation)
Day 8 - Spot 1 (n=13)	-0.2508 ± 4.8798
Day 8 - Spot 2 (n=13)	-1.8215 ± 3.3907
Day 8 - Spot 3 (n=13)	-0.7869 ± 2.9791
Day 15 - Spot 1 (n=14)	-0.5786 ± 3.3947
Day 15 - Spot 2 (n=14)	-1.0029 ± 3.4320
Day 15 - Spot 3 (n=14)	-0.3829 ± 3.3925
Day 22 - Spot 1 (n=12)	-0.7575 ± 3.2991
Day 22 - Spot 2 (n=12)	1.0233 ± 3.7207
Day 22 - Spot 3 (n=12)	0.6433 ± 2.0759
Day 29 - Spot 1 (n=13)	-1.1631 ± 3.1429
Day 29 - Spot 2 (n=13)	0.8585 ± 1.8609
Day 29 - Spot 3 (n=13)	0.7938 ± 1.7624
Day 43 - Spot 1 (n=14)	-1.0129 ± 4.0940
Day 43 - Spot 2 (n=14)	-0.8357 ± 4.7103
Day 43 - Spot 3 (n=14)	0.7057 ± 5.1247
Day 57 - Spot 1 (n=12)	0.6308 ± 4.1304
Day 57 - Spot 2 (n=12)	0.2283 ± 2.6839
Day 57 - Spot 3 (n=12)	1.5142 ± 4.1943
Day 85 - Spot 1 (n=14)	0.0164 ± 3.2348
Day 85 - Spot 2 (n=14)	-0.3221 ± 3.5460
Day 85 - Spot 3 (n=14)	0.2779 ± 3.8491
Day 113 - Spot 1 (n=11)	-0.3791 ± 3.4231
Day 113 - Spot 2 (n=11)	0.4882 ± 2.5528
Day 113 - Spot 3 (n=11)	2.0527 ± 2.1762
Day 155 - Spot 1 (n=15)	-0.9293 ± 6.5972
Day 155 - Spot 2 (n=15)	0.6880 ± 3.7653
Day 155 - Spot 3 (n=15)	0.4793 ± 4.5057
Day 197 - Spot 1 (n=15)	-0.6153 ± 4.8187
Day 197 - Spot 2 (n=15)	-0.0427 ± 3.6560
Day 197 - Spot 3 (n=15)	0.6747 ± 4.8536

No statistical analyses for this end point

Secondary: Percent Change From Baseline in Area Under the Curve (AUC) of TEWL on Lesional Skin in AD Subjects at Days 57, 113 and 197

Top of page

End point title

Percent Change From Baseline in Area Under the Curve (AUC) of TEWL on Lesional Skin in AD Subjects at Days 57, 113 and 197 ^[31]

End point description

TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum used to characterise SBF. TEWL combined with STS measures SBF. TEWL AUC done over defined number of STS used to reflect overall integrity of stratum corneum. LS areas for TEWL assessment & STS was identified at baseline (predefined skin area). Within predefined LS areas, 3 closely adjacent nonoverlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS & after 5, 10, 15 & 20 STS on pre-defined LS areas at specified time points. TEWL AUC was composite measure before and after 5, 10, 15 and 20 STS at each specified time point. AUC of TEWL: calculated for each visit using trapezoidal method. STS assessment at baseline (Week 0, Day 1), Days 57, 113 & 197 was conducted on first spot. Percent change from baseline at specified time points in TEWL AUC (first spot) in AD subjects were reported in this endpoint. mITT. 'Number of subjects analysed' = subjects with available data.

End point type

Secondary

End point timeframe

Baseline, Days 57, 113 and 197

Notes
[31] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this endpoint is reported for the applicable arm in the study.

End point values	Atopic Dermatitis Subjects
Number of subjects analysed	19 ^[32]
Units: percent change
arithmetic mean (standard deviation)
Day 57 (n=19)	-38.2091 ± 25.6654
Day 113 (n=18)	-34.0025 ± 29.1866
Day 197 (n=15)	-40.0143 ± 26.9737

Notes
[32] - Here, 'n' = subjects with available data for each category.

No statistical analyses for this end point

Secondary: Absolute Change From Baseline in AUC of TEWL on Lesional Skin in AD Subjects at Days 57, 113 and 197

Top of page

End point title

Absolute Change From Baseline in AUC of TEWL on Lesional Skin in AD Subjects at Days 57, 113 and 197 ^[33]

End point description

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum to characterise SBF. TEWL combined with STS measures SBF. TEWL AUC done over defined number of STS (nsts) used to reflect overall integrity of stratum corneum. LS areas for TEWL assessment & STS was identified at baseline (predefined skin area). Within predefined LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS & after 5, 10, 15 & 20 STS on pre-defined LS areas at specified time points. TEWL AUC was composite measure before and after 5, 10, 15 & 20 STS at each specified time point. AUC of TEWL: calculated for each visit using trapezoidal method. STS assessment at baseline (Week 0, Day 1), Days 57, 113 & 197 was conducted on first spot. Absolute change from baseline at specified time points in TEWL AUC (first spot) in AD subjects reported in this endpoint. mITT. 'Number of subjects analysed' = subjects with available data.

End point type

Secondary

End point timeframe

Baseline, Days 57, 113 and 197

Notes
[33] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this endpoint is reported for the applicable arm in the study.

End point values	Atopic Dermatitis Subjects
Number of subjects analysed	19 ^[34]
Units: nsts*grams per square metre per hour
arithmetic mean (standard deviation)
Day 57 (n=19)	-632.0224 ± 494.4981
Day 113 (n=18)	-608.1875 ± 601.7999
Day 197 (n=15)	-659.4033 ± 570.2425

Notes
[34] - Here, 'n' = subjects with available data for each category.

No statistical analyses for this end point

Secondary: Percent Change From Baseline in AUC of TEWL on Non-lesional Skin in AD Subjects at Days 57, 113 and 197

Top of page

End point title

Percent Change From Baseline in AUC of TEWL on Non-lesional Skin in AD Subjects at Days 57, 113 and 197 ^[35]

End point description

TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum used to characterise SBF. TEWL combined with STS measures SBF. TEWL AUC done over defined number of STS reflect the overall integrity of stratum corneum. Non-LS areas for TEWL assessment & STS was identified at baseline (predefined skin area). Within predefined non-LS areas, 3 closely adjacent nonoverlapping spots identified for subsequent SBF assessment. TEWL measured prior to STS & after 5, 10, 15 & 20 STS on pre-defined non-LS areas at specified time points. TEWL AUC was composite measure before & after 5, 10, 15 & 20 STS at each specified time point. AUC of TEWL: calculated for each visit using trapezoidal method. STS assessment at baseline (Week 0, Day 1), Days 57, 113 & 197 was conducted on first spot. Percent change from baseline at specified time points in TEWL AUC (first spot) in AD subjects were reported in this endpoint. mITT. 'Number of subjects analysed' = subjects with available data.

End point type

Secondary

End point timeframe

Baseline, Days 57, 113 and 197

Notes
[35] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this endpoint is reported for the applicable arm in the study.

End point values	Atopic Dermatitis Subjects
Number of subjects analysed	19 ^[36]
Units: percent change
arithmetic mean (standard deviation)
Day 57 (n=19)	-21.7570 ± 29.1137
Day 113 (n=17)	-10.8940 ± 50.7679
Day 197 (n=16)	-28.6897 ± 26.0253

Notes
[36] - Here, 'n' = subjects with available data for each category.

No statistical analyses for this end point

Secondary: Absolute Change From Baseline in AUC of TEWL on Non-lesional Skin in AD Subjects at Days 57, 113 and 197

Top of page

End point title

Absolute Change From Baseline in AUC of TEWL on Non-lesional Skin in AD Subjects at Days 57, 113 and 197 ^[37]

End point description

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum to characterise SBF. TEWL combined with STS measures SBF. TEWL AUC done over defined number of STS used to reflect overall integrity of stratum corneum. Non-LS areas for TEWL assessment & STS was identified at baseline (predefined skin area). Within predefined non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS & after 5, 10,15 & 20 STS on pre-defined non-LS areas at specified time points. TEWL AUC was composite measure before & after 5, 10, 15 & 20 STS at each specified time point. AUC of TEWL: calculated for each visit using trapezoidal method. STS assessment at baseline(Week 0, Day 1), Days 57, 113 & 197 was conducted on first spot. Absolute change from baseline at specified time points in TEWL AUC (first spot) in AD subjects reported in this endpoint. mITT. 'Number of subjects analysed' = subjects with available data.

End point type

Secondary

End point timeframe

Baseline, Days 57, 113 and 197

Notes
[37] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this endpoint is reported for the applicable arm in the study.

End point values	Atopic Dermatitis Subjects
Number of subjects analysed	19 ^[38]
Units: nsts*grams per square metre per hour
arithmetic mean (standard deviation)
Day 57 (n=19)	-281.9579 ± 342.1271
Day 113 (n=17)	-217.7544 ± 462.0173
Day 197 (n=16)	-367.5469 ± 340.1948

Notes
[38] - Here, 'n' = subjects with available data for each category.

No statistical analyses for this end point

Secondary: Percent Change From Baseline in AUC of TEWL on Normal Skin in Healthy Volunteers at Days 57, 113 and 197

Top of page

End point title

Percent Change From Baseline in AUC of TEWL on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 ^[39]

End point description

TEWL: noninvasive in vivo measurement of water loss across stratum corneum to characterise SBF. TEWL combined with STS measures SBF. TEWL AUC done over defined number of STS used to reflect overall integrity of stratum corneum. Normal skin areas for TEWL assessment & STS was identified at baseline (predefined skin area). Within predefined normal skin areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL measured prior to STS & after 5, 10,15 & 20 STS on pre-defined normal skin areas at specified time points. TEWL AUC: composite measure before & after 5, 10, 15 & 20 STS at each specified time point. AUC of TEWL: calculated for each visit using trapezoidal method. STS assessment at baseline (Week 0, Day 1), Days 57, 113 & 197 conducted on first spot. Percent Change from baseline at specified time points in TEWL AUC (first spot) in healthy volunteers reported in this endpoint. mITT. 'Number of subjects analysed' = subjects with available data.

End point type

Secondary

End point timeframe

Baseline, Days 57, 113 and 197

Notes
[39] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this endpoint is reported for the applicable arm in the study.

End point values	Healthy Volunteers
Number of subjects analysed	15 ^[40]
Units: percent change
arithmetic mean (standard deviation)
Day 57 (n=12)	3.2794 ± 15.6493
Day 113 (n=11)	3.4753 ± 30.2504
Day 197 (n=15)	-10.1582 ± 18.4753

Notes
[40] - Here, 'n' = subjects with available data for each category.

No statistical analyses for this end point

Secondary: Absolute Change From Baseline in AUC of TEWL on Normal Skin in Healthy Volunteers at Days 57, 113 and 197

Top of page

End point title

Absolute Change From Baseline in AUC of TEWL on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 ^[41]

End point description

TEWL: noninvasive in vivo measurement of water loss across stratum corneum to characterise SBF. TEWL combined with STS measures SBF. TEWL AUC done over defined number of STS used to reflect overall integrity of stratum corneum. Normal skin areas for TEWL assessment & STS identified at baseline (predefined skin area). Within predefined Normal skin areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL measured prior to STS & after 5, 10,15 & 20 STS on pre-defined Normal skin areas at specified time points. TEWL AUC was composite measure before & after 5, 10, 15 & 20 STS at each specified time point. AUC of TEWL: calculated for each visit using trapezoidal method. STS assessment at baseline (Week 0, Day 1), Days 57, 113 & 197 conducted on first spot. Percent Change from baseline at specified time points in TEWL AUC (first spot) in healthy volunteers reported in this endpoint. mITT. 'Number of subjects analysed' = subjects with available data.

End point type

Secondary

End point timeframe

Baseline, Days 57, 113 and 197

Notes
[41] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this endpoint is reported for the applicable arm in the study.

End point values	Healthy Volunteers
Number of subjects analysed	15 ^[42]
Units: nsts*grams per square metre per hour
arithmetic mean (standard deviation)
Day 57 (n=12)	16.8563 ± 70.4582
Day 113 (n=11)	2.5568 ± 197.8379
Day 197 (n=15)	-72.9050 ± 108.8230

Notes
[42] - Here, 'n' = subjects with available data for each category.

No statistical analyses for this end point

Secondary: Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Subjects at Days 57, 113 and 197

Top of page

End point title

Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Subjects at Days 57, 113 and 197 ^[43]

End point description

TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterise SBF. TEWL combined with STS measures SBF. With STS, uppermost layers of skin are peeled away using adhesive discs. LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within predefined LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL: measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at baseline (Week 0, Day 1), Day 57, 113 and 197 was conducted on first spot. Percent change from baseline at specified time points in TEWL after STS on LS (first spot) in AD subjects were reported in this endpoint. mITT population. Here, 'number of subjects analysed' = subjects with available data for this endpoint and 'n' = subjects with available data for each specified category.

End point type

Secondary

End point timeframe

Baseline, Days 57, 113 and 197

Notes
[43] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this endpoint is reported for the applicable arm in the study.

End point values	Atopic Dermatitis Subjects
Number of subjects analysed	19
Units: percent change
arithmetic mean (standard deviation)
After 5 STS: Day 57 (n=19)	-42.2019 ± 22.5314
After 5 STS: Day 113 (n=18)	-38.5633 ± 27.1211
After 5 STS: Day 197 (n=15)	-36.4601 ± 47.5902
After 10 STS: Day 57 (n=18)	-40.4595 ± 27.4572
After 10 STS: Day 113 (n=17)	-34.7741 ± 31.0541
After 10 STS: Day 197 (n=13)	-39.9440 ± 29.2084
After 15 STS: Day 57 (n=19)	-41.6561 ± 24.0960
After 15 STS: Day 113 (n=18)	-33.3119 ± 32.7125
After 15 STS: Day 197 (n=14)	-38.4286 ± 27.0978
After 20 STS: Day 57 (n=19)	-34.8297 ± 23.0520
After 20 STS: Day 113 (n=17)	-33.1336 ± 28.1613
After 20 STS: Day 197 (n=14)	-35.6561 ± 23.0987

No statistical analyses for this end point

Secondary: Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Subjects at Days 57, 113 and 197

Top of page

End point title

Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Subjects at Days 57, 113 and 197 ^[44]

End point description

TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterise SBF. TEWL combined with STS measures SBF. With STS, uppermost layers of skin are peeled away using adhesive discs. LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within predefined LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL: measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at baseline (Week 0, Day 1), Day 57, 113 and 197 was conducted on first spot. Absolute change from baseline at specified time points in TEWL after STS on LS (first spot) in AD subjects were reported in this endpoint. Analysis was performed on mITT population. Here, 'number of subjects analysed' = subjects with available data for this endpoint and 'n'= subjects with available data for each specified category.

End point type

Secondary

End point timeframe

Baseline, Days 57, 113 and 197

Notes
[44] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this endpoint is reported for the applicable arm in the study.

End point values	Atopic Dermatitis Subjects
Number of subjects analysed	19
Units: grams per square metre per hour
arithmetic mean (standard deviation)
After 5 STS: Day 57 (n=19)	-31.3795 ± 25.4943
After 5 STS: Day 113 (n=18)	-31.1761 ± 31.3420
After 5 STS: Day 197 (n=15)	-33.5753 ± 40.1857
After 10 STS: Day 57 (n=18)	-36.4267 ± 31.1758
After 10 STS: Day 113 (n=17)	-33.1024 ± 36.2286
After 10 STS: Day 197 (n=13)	-35.8254 ± 33.3362
After 15 STS: Day 57 (n=19)	-37.9779 ± 23.3049
After 15 STS: Day 113 (n=18)	-33.4028 ± 31.1957
After 15 STS: Day 197 (n=14)	-36.0843 ± 27.5612
After 20 STS: Day 57 (n=19)	-35.0726 ± 23.5765
After 20 STS: Day 113 (n=17)	-35.6671 ± 31.2267
After 20 STS: Day 197 (n=14)	-34.5257 ± 23.9001

No statistical analyses for this end point

Secondary: Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Subjects at Days 57, 113 and 197

Top of page

End point title

Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Subjects at Days 57, 113 and 197 ^[45]

End point description

TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterise SBF. TEWL combined with STS measures SBF. With STS, uppermost layers of skin are peeled away using adhesive discs. Non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within predefined non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL: measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at baseline (Week 0, Day 1), Day 57, 113 and 197 was conducted on first spot. Percent change from baseline at specified time points in TEWL after STS on non-LS (first spot) in AD subjects were reported in this endpoint. Analysis was performed on mITT population. Here, 'number of subjects analysed' = subjects with available data for this endpoint and 'n' = subjects with available data for each specified category.

End point type

Secondary

End point timeframe

Baseline, Days 57, 113 and 197

Notes
[45] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this endpoint is reported for the applicable arm in the study.

End point values	Atopic Dermatitis Subjects
Number of subjects analysed	19
Units: percent change
arithmetic mean (standard deviation)
After 5 STS: Day 57 (n=19)	-24.8218 ± 31.4633
After 5 STS: Day 113 (n=17)	-4.8842 ± 70.5670
After 5 STS: Day 197 (n=16)	-29.7635 ± 44.0691
After 10 STS: Day 57 (n=19)	-20.3640 ± 43.5318
After 10 STS: Day 113 (n=17)	-3.8193 ± 74.6263
After 10 STS: Day 197 (n=16)	-29.6888 ± 38.9536
After 15 STS: Day 57 (n=19)	-18.4348 ± 33.3647
After 15 STS: Day 113 (n=17)	-7.6067 ± 54.7945
After 15 STS: Day 197 (n=16)	-27.2268 ± 25.1580
After 20 STS: Day 57 (n=19)	-19.2584 ± 30.1343
After 20 STS: Day 113 (n=17)	-6.1452 ± 67.9496
After 20 STS: Day 197 (n=16)	-22.3311 ± 23.0908

No statistical analyses for this end point

Secondary: Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Subjects at Days 57, 113 and 197

Top of page

End point title

Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Subjects at Days 57, 113 and 197 ^[46]

End point description

TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterise SBF. TEWL combined with STS measures SBF. With STS, uppermost layers of skin are peeled away using adhesive discs. Non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within predefined non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL: measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at baseline (Week 0, Day 1), Day 57, 113 and 197 was conducted on first spot. Absolute change from baseline at specified time points in TEWL after STS on non-LS (first spot) in AD subjects were reported in this endpoint. Analysis was performed on mITT population. Here, 'number of subjects analysed' = subjects with available data for this endpoint and 'n'=subjects with available data for each specified category.

End point type

Secondary

End point timeframe

Baseline, Days 57, 113 and 197

Notes
[46] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this endpoint is reported for the applicable arm in the study.

End point values	Atopic Dermatitis Subjects
Number of subjects analysed	19
Units: grams per square metre per hour
arithmetic mean (standard deviation)
After 5 STS: Day 57 (n=19)	-11.8526 ± 12.6180
After 5 STS: Day 113 (n=17)	-9.0771 ± 21.3022
After 5 STS: Day 197 (n=16)	-15.8375 ± 18.0369
After 10 STS: Day 57 (n=19)	-15.0005 ± 20.1721
After 10 STS: Day 113 (n=17)	-10.9488 ± 31.1300
After 10 STS: Day 197 (n=16)	-21.2825 ± 23.2998
After 15 STS: Day 57 (n=19)	-16.1047 ± 26.4807
After 15 STS: Day 113 (n=17)	-12.6576 ± 30.0412
After 15 STS: Day 197 (n=16)	-21.9006 ± 19.2885
After 20 STS: Day 57 (n=19)	-18.5800 ± 30.3574
After 20 STS: Day 113 (n=17)	-13.6682 ± 33.3065
After 20 STS: Day 197 (n=16)	-20.0575 ± 16.1537

No statistical analyses for this end point

Secondary: Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197

Top of page

End point title

Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 ^[47]

End point description

TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterise SBF. TEWL combined with STS measures SBF. With STS, uppermost layers of skin are peeled away using adhesive discs. Normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within predefined normal skin areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 ST Son pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1), Day 57, 113 and 197 was conducted on first spot. Percent change from baseline at specified time points in TEWL after STS on normal skin (first spot) in healthy volunteers were reported in this endpoint. mITT population. Here, 'number of subjects analysed' = subjects with available data for this endpoint and 'n'=subjects with available data for each specified category.

End point type

Secondary

End point timeframe

Baseline, Days 57, 113 and 197

Notes
[47] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this endpoint is reported for the applicable arm in the study.

End point values	Healthy Volunteers
Number of subjects analysed	15
Units: percent change
arithmetic mean (standard deviation)
After 5 STS: Day 57 (n=12)	4.9595 ± 16.0950
After 5 STS: Day 113 (n=11)	1.4464 ± 26.7257
After 5 STS: Day 197 (n=15)	-1.6729 ± 25.2293
After 10 STS: Day 57 (n=12)	4.0996 ± 20.4647
After 10 STS: Day 113 (n=11)	0.7091 ± 25.0615
After 10 STS: Day 197 (n=15)	-7.4475 ± 19.7215
After 15 STS: Day 57 (n=12)	3.2339 ± 20.9086
After 15 STS: Day 113 (n=11)	4.5364 ± 42.7525
After 15 STS: Day 197 (n=15)	-14.0103 ± 18.5552
After 20 STS: Day 57 (n=12)	4.3494 ± 27.5527
After 20 STS: Day 113 (n=11)	13.2578 ± 64.3880
After 20 STS: Day 197 (n=15)	-18.0480 ± 22.6193

No statistical analyses for this end point

Secondary: Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197

Top of page

End point title

Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 ^[48]

End point description

TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterise SBF. TEWL combined with STS measures SBF. With STS, uppermost layers of skin are peeled away using adhesive discs. Normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within predefined normal skin areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1), Day 57, 113 and 197 was conducted on first spot. Absolute change from baseline at specified time points in TEWL after STS on normal skin (first spot) in healthy volunteers were reported in this endpoint. mITT population. Here, 'number of subjects analysed' =subjects with available data for this endpoint and 'n' = subjects with available data for each specified category.

End point type

Secondary

End point timeframe

Baseline, Days 57, 113 and 197

Notes
[48] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this endpoint is reported for the applicable arm in the study.

End point values	Healthy Volunteers
Number of subjects analysed	15
Units: grams per square metre per hour
arithmetic mean (standard deviation)
After 5 STS: Day 57 (n=12)	0.5642 ± 3.3355
After 5 STS: Day 113 (n=11)	-1.0255 ± 4.3657
After 5 STS: Day 197 (n=15)	-1.5627 ± 5.2934
After 10 STS: Day 57 (n=12)	0.2825 ± 4.5142
After 10 STS: Day 113 (n=11)	-1.3482 ± 6.6778
After 10 STS: Day 197 (n=15)	-3.0880 ± 5.2754
After 15 STS: Day 57 (n=12)	0.4750 ± 6.4442
After 15 STS: Day 113 (n=11)	0.1082 ± 17.5865
After 15 STS: Day 197 (n=15)	-5.8847 ± 8.1968
After 20 STS: Day 57 (n=12)	3.4683 ± 9.8235
After 20 STS: Day 113 (n=11)	5.9327 ± 32.0123
After 20 STS: Day 197 (n=15)	-7.4760 ± 9.3514

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

For AD subjects: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., up to Day 197)

Adverse event reporting additional description

Analysis was performed on safety population that included all subjects, who actually received at least 1 dose of IMP or had at least 1 TEWL/STS assessment and all healthy volunteers who have at least 1 TEWL/STS assessment performed.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

25.1

Reporting group title

Atopic Dermatitis Subjects

Reporting group description

Pediatric subjects with moderate-to-severe AD and with baseline body weight >= 15 kg and < 30 kg received SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric subjects with body weight >= 30 kg and <60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14.

Reporting group title

Healthy Volunteers

Reporting group description

Healthy volunteers with age, gender, location of targeted skin lesion area and study site matched to selected AD subjects, received no treatment, but were monitored in similar way as AD subjects.

Serious adverse events	Atopic Dermatitis Subjects	Healthy Volunteers
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 23 (0.00%)	0 / 18 (0.00%)
number of deaths (all causes)	0	0
number of deaths resulting from adverse events	0	0

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	Atopic Dermatitis Subjects	Healthy Volunteers
Total subjects affected by non serious adverse events
subjects affected / exposed	21 / 23 (91.30%)	6 / 18 (33.33%)
Injury, poisoning and procedural complications
Wound
subjects affected / exposed	1 / 23 (4.35%)	0 / 18 (0.00%)
occurrences all number	1	0
Tendon Injury
subjects affected / exposed	1 / 23 (4.35%)	0 / 18 (0.00%)
occurrences all number	1	0
Arthropod Sting
subjects affected / exposed	1 / 23 (4.35%)	0 / 18 (0.00%)
occurrences all number	1	0
Nervous system disorders
Headache
subjects affected / exposed	3 / 23 (13.04%)	1 / 18 (5.56%)
occurrences all number	4	1
Lethargy
subjects affected / exposed	1 / 23 (4.35%)	0 / 18 (0.00%)
occurrences all number	1	0
Blood and lymphatic system disorders
Lymphadenopathy
subjects affected / exposed	0 / 23 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	1
General disorders and administration site conditions
Medical Device Site Haemorrhage
subjects affected / exposed	6 / 23 (26.09%)	0 / 18 (0.00%)
occurrences all number	7	0
Pyrexia
subjects affected / exposed	0 / 23 (0.00%)	2 / 18 (11.11%)
occurrences all number	0	2
Immune system disorders
Food Allergy
subjects affected / exposed	1 / 23 (4.35%)	0 / 18 (0.00%)
occurrences all number	1	0
Seasonal Allergy
subjects affected / exposed	0 / 23 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	1
Eye disorders
Dry Eye
subjects affected / exposed	1 / 23 (4.35%)	0 / 18 (0.00%)
occurrences all number	1	0
Eye Irritation
subjects affected / exposed	1 / 23 (4.35%)	0 / 18 (0.00%)
occurrences all number	1	0
Vision Blurred
subjects affected / exposed	1 / 23 (4.35%)	0 / 18 (0.00%)
occurrences all number	1	0
Ocular Hyperaemia
subjects affected / exposed	1 / 23 (4.35%)	0 / 18 (0.00%)
occurrences all number	1	0
Eye Pruritus
subjects affected / exposed	2 / 23 (8.70%)	0 / 18 (0.00%)
occurrences all number	2	0
Eye Pain
subjects affected / exposed	1 / 23 (4.35%)	0 / 18 (0.00%)
occurrences all number	1	0
Gastrointestinal disorders
Vomiting
subjects affected / exposed	1 / 23 (4.35%)	0 / 18 (0.00%)
occurrences all number	1	0
Nausea
subjects affected / exposed	1 / 23 (4.35%)	0 / 18 (0.00%)
occurrences all number	1	0
Abdominal Pain Upper
subjects affected / exposed	1 / 23 (4.35%)	0 / 18 (0.00%)
occurrences all number	2	0
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	1 / 23 (4.35%)	1 / 18 (5.56%)
occurrences all number	1	1
Oropharyngeal Pain
subjects affected / exposed	1 / 23 (4.35%)	0 / 18 (0.00%)
occurrences all number	1	0
Skin and subcutaneous tissue disorders
Dermatitis Atopic
subjects affected / exposed	9 / 23 (39.13%)	0 / 18 (0.00%)
occurrences all number	10	0
Urticaria
subjects affected / exposed	3 / 23 (13.04%)	0 / 18 (0.00%)
occurrences all number	3	0
Rash Erythematous
subjects affected / exposed	1 / 23 (4.35%)	0 / 18 (0.00%)
occurrences all number	1	0
Erythema
subjects affected / exposed	1 / 23 (4.35%)	0 / 18 (0.00%)
occurrences all number	1	0
Musculoskeletal and connective tissue disorders
Pain In Extremity
subjects affected / exposed	1 / 23 (4.35%)	0 / 18 (0.00%)
occurrences all number	1	0
Infections and infestations
Upper Respiratory Tract Infection
subjects affected / exposed	4 / 23 (17.39%)	0 / 18 (0.00%)
occurrences all number	5	0
Urinary Tract Infection
subjects affected / exposed	1 / 23 (4.35%)	0 / 18 (0.00%)
occurrences all number	1	0
Tonsillitis
subjects affected / exposed	1 / 23 (4.35%)	0 / 18 (0.00%)
occurrences all number	1	0
Suspected Covid-19
subjects affected / exposed	1 / 23 (4.35%)	0 / 18 (0.00%)
occurrences all number	1	0
Skin Bacterial Infection
subjects affected / exposed	0 / 23 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	1
Pneumonia
subjects affected / exposed	1 / 23 (4.35%)	0 / 18 (0.00%)
occurrences all number	1	0
Otitis Media Chronic
subjects affected / exposed	1 / 23 (4.35%)	0 / 18 (0.00%)
occurrences all number	1	0
Molluscum Contagiosum
subjects affected / exposed	1 / 23 (4.35%)	0 / 18 (0.00%)
occurrences all number	1	0
Impetigo
subjects affected / exposed	1 / 23 (4.35%)	0 / 18 (0.00%)
occurrences all number	1	0
Gastrointestinal Viral Infection
subjects affected / exposed	1 / 23 (4.35%)	0 / 18 (0.00%)
occurrences all number	1	0
Gastroenteritis
subjects affected / exposed	1 / 23 (4.35%)	0 / 18 (0.00%)
occurrences all number	1	0
Dermatitis Infected
subjects affected / exposed	1 / 23 (4.35%)	0 / 18 (0.00%)
occurrences all number	1	0
Cellulitis
subjects affected / exposed	1 / 23 (4.35%)	0 / 18 (0.00%)
occurrences all number	1	0
Covid-19
subjects affected / exposed	1 / 23 (4.35%)	1 / 18 (5.56%)
occurrences all number	1	1

More information

Top of page

Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

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

None reported

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Clinical Trial Results: Open-label Exploratory Study to Evaluate the Effect of Dupilumab on Skin Barrier Function in Pediatric Patients with Moderate to Severe Atopic Dermatitis

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percent Change From Baseline in Transepidermal Water Loss (TEWL) After 5 Skin Tape Stripping (STS) on Lesional Skin (LS) in AD Subjects at Week 16

Primary: Percent Change From Baseline in Transepidermal Water Loss (TEWL) After 5 Skin Tape Stripping (STS) on Lesional Skin (LS) in AD Subjects at Week 16

Secondary: Percent Change From Baseline in TEWL After 20 STS on Lesional Skin in AD Subjects at Week 16

Secondary: Percent Change From Baseline in TEWL After 20 STS on Lesional Skin in AD Subjects at Week 16

Secondary: Absolute Change From Baseline in TEWL After 20 STS on Lesional Skin in AD Subjects at Week 16

Secondary: Absolute Change From Baseline in TEWL After 20 STS on Lesional Skin in AD Subjects at Week 16

Secondary: Percent Change From Baseline in TEWL After 20 STS on Non-lesional Skin (Non-LS) in AD Subjects at Week 16

Secondary: Percent Change From Baseline in TEWL After 20 STS on Non-lesional Skin (Non-LS) in AD Subjects at Week 16

Secondary: Absolute Change From Baseline in TEWL After 20 STS on Non-lesional Skin in AD Subjects at Week 16

Secondary: Absolute Change From Baseline in TEWL After 20 STS on Non-lesional Skin in AD Subjects at Week 16

Secondary: Percent Change From Baseline in TEWL After 20 STS on Normal Skin in Healthy Volunteers at Week 16

Secondary: Percent Change From Baseline in TEWL After 20 STS on Normal Skin in Healthy Volunteers at Week 16

Secondary: Absolute Change From Baseline in TEWL After 20 STS on Normal Skin in Healthy Volunteers at Week 16

Secondary: Absolute Change From Baseline in TEWL After 20 STS on Normal Skin in Healthy Volunteers at Week 16

Secondary: Percent Change From Baseline in TEWL After 15 STS on Lesional Skin in AD Subjects at Week 16

Secondary: Percent Change From Baseline in TEWL After 15 STS on Lesional Skin in AD Subjects at Week 16

Secondary: Absolute Change From Baseline in TEWL After 15 STS on Lesional Skin in AD Subjects at Week 16

Secondary: Absolute Change From Baseline in TEWL After 15 STS on Lesional Skin in AD Subjects at Week 16

Secondary: Percent Change From Baseline in TEWL After 15 STS on Non-lesional Skin in AD Subjects at Week 16

Secondary: Percent Change From Baseline in TEWL After 15 STS on Non-lesional Skin in AD Subjects at Week 16

Secondary: Absolute Change From Baseline in TEWL After 15 STS on Non-lesional Skin in AD Subjects at Week 16

Secondary: Absolute Change From Baseline in TEWL After 15 STS on Non-lesional Skin in AD Subjects at Week 16

Secondary: Percent Change From Baseline in TEWL After 15 STS on Normal Skin in Healthy Volunteers at Week 16

Secondary: Percent Change From Baseline in TEWL After 15 STS on Normal Skin in Healthy Volunteers at Week 16

Secondary: Absolute Change From Baseline in TEWL After 15 STS on Normal Skin in Healthy Volunteers at Week 16

Secondary: Absolute Change From Baseline in TEWL After 15 STS on Normal Skin in Healthy Volunteers at Week 16

Secondary: Percent Change From Baseline in TEWL After 10 STS on Lesional Skin in AD Subjects at Week 16

Secondary: Percent Change From Baseline in TEWL After 10 STS on Lesional Skin in AD Subjects at Week 16

Secondary: Absolute Change From Baseline in TEWL After 10 STS on Lesional Skin in AD Subjects at Week 16

Secondary: Absolute Change From Baseline in TEWL After 10 STS on Lesional Skin in AD Subjects at Week 16

Secondary: Percent Change From Baseline in TEWL After 10 STS on Non-lesional Skin in AD Subjects at Week 16

Secondary: Percent Change From Baseline in TEWL After 10 STS on Non-lesional Skin in AD Subjects at Week 16

Secondary: Absolute Change From Baseline in TEWL After 10 STS on Non-lesional Skin in AD Subjects at Week 16

Secondary: Absolute Change From Baseline in TEWL After 10 STS on Non-lesional Skin in AD Subjects at Week 16

Secondary: Percent Change From Baseline in TEWL After 10 STS on Normal Skin in Healthy Volunteers at Week 16

Secondary: Percent Change From Baseline in TEWL After 10 STS on Normal Skin in Healthy Volunteers at Week 16

Secondary: Absolute Change From Baseline in TEWL After 10 STS on Normal Skin in Healthy Volunteers at Week 16

Secondary: Absolute Change From Baseline in TEWL After 10 STS on Normal Skin in Healthy Volunteers at Week 16

Secondary: Percent Change From Baseline in TEWL After 5 STS on Non-lesional Skin in AD Subjects at Week 16

Secondary: Percent Change From Baseline in TEWL After 5 STS on Non-lesional Skin in AD Subjects at Week 16

Secondary: Absolute Change From Baseline in TEWL After 5 STS on Non-lesional Skin in AD Subjects at Week 16

Secondary: Absolute Change From Baseline in TEWL After 5 STS on Non-lesional Skin in AD Subjects at Week 16

Secondary: Percent Change From Baseline in TEWL After 5 STS on Normal Skin in Healthy Volunteers at Week 16

Secondary: Percent Change From Baseline in TEWL After 5 STS on Normal Skin in Healthy Volunteers at Week 16

Secondary: Absolute Change From Baseline in TEWL After 5 STS on Normal Skin in Healthy Volunteers at Week 16

Secondary: Absolute Change From Baseline in TEWL After 5 STS on Normal Skin in Healthy Volunteers at Week 16

Secondary: Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Subjects at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197

Secondary: Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Subjects at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197

Secondary: Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Subjects at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197

Secondary: Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Subjects at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197

Secondary: Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Subjects at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197

Secondary: Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Subjects at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197

Secondary: Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Subjects at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197

Secondary: Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Subjects at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197

Secondary: Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197

Secondary: Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197

Secondary: Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197

Secondary: Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197

Secondary: Percent Change From Baseline in Area Under the Curve (AUC) of TEWL on Lesional Skin in AD Subjects at Days 57, 113 and 197

Secondary: Percent Change From Baseline in Area Under the Curve (AUC) of TEWL on Lesional Skin in AD Subjects at Days 57, 113 and 197

Secondary: Absolute Change From Baseline in AUC of TEWL on Lesional Skin in AD Subjects at Days 57, 113 and 197

Secondary: Absolute Change From Baseline in AUC of TEWL on Lesional Skin in AD Subjects at Days 57, 113 and 197

Secondary: Percent Change From Baseline in AUC of TEWL on Non-lesional Skin in AD Subjects at Days 57, 113 and 197

Secondary: Percent Change From Baseline in AUC of TEWL on Non-lesional Skin in AD Subjects at Days 57, 113 and 197

Secondary: Absolute Change From Baseline in AUC of TEWL on Non-lesional Skin in AD Subjects at Days 57, 113 and 197

Secondary: Absolute Change From Baseline in AUC of TEWL on Non-lesional Skin in AD Subjects at Days 57, 113 and 197

Secondary: Percent Change From Baseline in AUC of TEWL on Normal Skin in Healthy Volunteers at Days 57, 113 and 197

Secondary: Percent Change From Baseline in AUC of TEWL on Normal Skin in Healthy Volunteers at Days 57, 113 and 197

Secondary: Absolute Change From Baseline in AUC of TEWL on Normal Skin in Healthy Volunteers at Days 57, 113 and 197

Secondary: Absolute Change From Baseline in AUC of TEWL on Normal Skin in Healthy Volunteers at Days 57, 113 and 197

Clinical Trial Results:
Open-label Exploratory Study to Evaluate the Effect of Dupilumab on Skin Barrier Function in Pediatric Patients with Moderate to Severe Atopic Dermatitis