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    Clinical Trial Results:
    A Phase 2a, Randomized, Double Blind, Vehicle Controlled, Parallel Group Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of PF-07038124 Ointment for 6 Weeks in Subjects With Mild to Moderate Atopic Dermatitis or Plaque Psoriasis

    Summary
    EudraCT number
    		 2020-003977-23
    Trial protocol
    		 PL  
    Global end of trial date
    18 Aug 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Aug 2022
    First version publication date
    17 Aug 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    C3941002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04664153
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., +1 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., +1 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    18 Aug 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Aug 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Aug 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives of the study were to compare the efficacy of PF-07038124 versus vehicle on percent change from baseline in EASI in subjects with mild or moderate AD, and to compare the efficacy of PF-07038124 versus vehicle on change from baseline in PASI score in subjects with mild to moderate plaque psoriasis.
    Protection of trial subjects
    This study was conducted in compliance with the ethical principles originating in or derived from the Declaration of Helsinki and in compliance with all International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guidelines. In addition, all local regulatory requirements were followed, in particular, those affording greater protection to the safety of trial subjects.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Dec 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 4
    Country: Number of subjects enrolled
    Canada: 12
    Country: Number of subjects enrolled
    Poland: 19
    Country: Number of subjects enrolled
    United States: 69
    Worldwide total number of subjects
    104
    EEA total number of subjects
    19
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    95
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 152 subjects were screened for this study and 104 subjects were assigned to study treatment (70 for atopic dermatitis [AD] group and 34 for plaque psoriasis group).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AD Vehicle Once Daily (QD)
    Arm description
    		 Subjects in AD group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Topical use
    Dosage and administration details
    Placebo was administered topically with QD dosing for 6 weeks.

    Arm title
    		 AD PF-07038124 0.01% QD
    Arm description
    		 Subjects in AD group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-07038124
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Topical use
    Dosage and administration details
    PF-07038124 was administered topically with QD dosing for 6 weeks.

    Arm title
    		 Psoriasis Vehicle QD
    Arm description
    		 Subjects in plaque psoriasis group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Topical use
    Dosage and administration details
    Placebo was administered topically with QD dosing for 6 weeks.

    Arm title
    		 Psoriasis PF-07038124 0.01% QD
    Arm description
    		 Subjects in plaque psoriasis group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-07038124
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Topical use
    Dosage and administration details
    PF-07038124 was administered topically with QD dosing for 6 weeks.

    Number of subjects in period 1
    		AD Vehicle Once Daily (QD) AD PF-07038124 0.01% QD Psoriasis Vehicle QD Psoriasis PF-07038124 0.01% QD
    Started
    34
    36
    17
    17
    Completed
    27
    33
    13
    15
    Not completed
    7
    3
    4
    2
         Consent withdrawn by subject
    3
    2
    1
    2
         Physician decision
    -
    -
    1
    -
         Adverse event, non-fatal
    4
    -
    1
    -
         Unspecified
    -
    1
    -
    -
         Lack of efficacy
    -
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    AD Vehicle Once Daily (QD)
    Reporting group description
    		 Subjects in AD group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.

    Reporting group title
    AD PF-07038124 0.01% QD
    Reporting group description
    		 Subjects in AD group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.

    Reporting group title
    Psoriasis Vehicle QD
    Reporting group description
    		 Subjects in plaque psoriasis group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.

    Reporting group title
    Psoriasis PF-07038124 0.01% QD
    Reporting group description
    		 Subjects in plaque psoriasis group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.

    Reporting group values
    		 AD Vehicle Once Daily (QD) AD PF-07038124 0.01% QD Psoriasis Vehicle QD Psoriasis PF-07038124 0.01% QD Total
    Number of subjects
    		 34 36 17 17 104
    Age Categorical
    Units: Subjects
        18-44
    		 25 23 4 4 56
        45-64
    		 9 8 12 10 39
        >=65
    		 0 5 1 3 9
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 36.1 ( 13.93 ) 41.4 ( 16.61 ) 51.2 ( 10.83 ) 51.8 ( 12.32 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 21 20 7 7 55
        Male
    		 13 16 10 10 49
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 25 29 17 16 87
        Black or African American
    		 8 5 0 0 13
        Asian
    		 1 2 0 1 4
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 8 11 7 5 31
        Not Hispanic or Latino
    		 26 25 10 12 73
        Unknown or Not Reported
    		 0 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    AD Vehicle Once Daily (QD)
    Reporting group description
    		 Subjects in AD group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.

    Reporting group title
    AD PF-07038124 0.01% QD
    Reporting group description
    		 Subjects in AD group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.

    Reporting group title
    Psoriasis Vehicle QD
    Reporting group description
    		 Subjects in plaque psoriasis group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.

    Reporting group title
    Psoriasis PF-07038124 0.01% QD
    Reporting group description
    		 Subjects in plaque psoriasis group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.

    Primary: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6 for AD Participants

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    End point title
    		 Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6 for AD Participants [1]
    End point description
    EASI evaluated severity of subjects’ AD based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD scored on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, where higher scores = greater severity of AD. Analysis population included all subjects who received at least 1 dose of study treatment. For this end point, data collection was not planned for the 2 arms of Psoriasis Vehicle QD and Psoriasis PF-07038124 0.01% QD.
    End point type
    Primary
    End point timeframe
    Baseline, Week 6
    Notes
    [1] - 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: This endpoint was summarized for specified reporting arms only.
    End point values
    		 AD Vehicle Once Daily (QD) AD PF-07038124 0.01% QD
    Number of subjects analysed
    34
    36
    Units: Percent Change
        least squares mean (confidence interval 90%)
    -35.5 (-48.95 to -22.03)
    -74.9 (-88.81 to -61.06)
    Statistical analysis title
    		 Difference From Vehicle
    Comparison groups
    AD Vehicle Once Daily (QD) v AD PF-07038124 0.01% QD
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0004
    Method
    		 t-test, 1-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -39.4
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -58.76
         upper limit
    		 -20.12
    Variability estimate
    Standard error of the mean
    Dispersion value
    11.74

    Primary: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 6 for Plaque Psoriasis Participants

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    End point title
    		 Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 6 for Plaque Psoriasis Participants [2]
    End point description
    Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90–100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease, where higher scores = greater severity of psoriasis. Analysis population included all subjects who received at least 1 dose of study treatment. For this end point, data collection was not planned for the 2 arms of AD Vehicle QD and AD PF-07038124 0.01% QD.
    End point type
    Primary
    End point timeframe
    Baseline, Week 6
    Notes
    [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: This endpoint was summarized for specified reporting arms only.
    End point values
    		 Psoriasis Vehicle QD Psoriasis PF-07038124 0.01% QD
    Number of subjects analysed
    17
    17
    Units: Units on a Scale
        least squares mean (confidence interval 90%)
    0.1 (-1.47 to 1.68)
    -4.8 (-6.21 to -3.37)
    Statistical analysis title
    		 Difference From Vehicle
    Comparison groups
    Psoriasis Vehicle QD v Psoriasis PF-07038124 0.01% QD
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 t-test, 1-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -4.9
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -7.02
         upper limit
    		 -2.77
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.29

    Secondary: Percentage of AD Subjects Achieving Investigator’s Global Assessment (IGA) Score of Clear (0) or Almost Clear (1) (on a 5-Point Scale) and a Reduction From Baseline of >=2 Points at Week 6

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    End point title
    		 Percentage of AD Subjects Achieving Investigator’s Global Assessment (IGA) Score of Clear (0) or Almost Clear (1) (on a 5-Point Scale) and a Reduction From Baseline of >=2 Points at Week 6 [3]
    End point description
    IGA assessed severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared-light pink residual lesions, just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Analysis population included all subjects who received at least 1 dose of study treatment. For this end point, data collection was not planned for the 2 arms of Psoriasis Vehicle QD and Psoriasis PF-07038124 0.01% QD.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 6
    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: This endpoint was summarized for specified reporting arms only.
    End point values
    		 AD Vehicle Once Daily (QD) AD PF-07038124 0.01% QD
    Number of subjects analysed
    34
    36
    Units: Percentage of Subjects
        number (confidence interval 90%)
    8.8 (3.3 to 19.7)
    44.4 (30.2 to 59.1)
    No statistical analyses for this end point

    Secondary: Percentage of AD Subjects Achieving EASI 75 (75% Improvement From Baseline) at Weeks 1, 2, 4, 6 and Follow-up (FUP)/End of Study (EOS)

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    End point title
    		 Percentage of AD Subjects Achieving EASI 75 (75% Improvement From Baseline) at Weeks 1, 2, 4, 6 and Follow-up (FUP)/End of Study (EOS) [4]
    End point description
    EASI evaluated severity of subjects’ AD based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD scored on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity. EASI 75 response was defined as at least a 75% reduction in EASI relative to Baseline. Analysis population included all subjects who received at least 1 dose. Data collection was not planned for the 2 arms of Psoriasis Vehicle QD and Psoriasis PF-07038124 0.01% QD.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)
    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: This endpoint was summarized for specified reporting arms only.
    End point values
    		 AD Vehicle Once Daily (QD) AD PF-07038124 0.01% QD
    Number of subjects analysed
    34 [5]
    36
    Units: Percentage of Subjects
    number (confidence interval 90%)
        Week 1
    0 (0.0 to 8.0)
    8.3 (3.1 to 18.9)
        Week 2
    0 (0.0 to 8.2)
    27.8 (15.9 to 40.9)
        Week 4
    11.8 (5.2 to 24.3)
    33.3 (21.3 to 47.0)
        Week 6
    20.6 (11.3 to 34.9)
    61.1 (47.0 to 74.6)
        FUP/EOS
    8.8 (3.3 to 19.7)
    44.4 (30.2 to 59.1)
    Notes
    [5] - Number of subjects analyzed for Week 2 was 33.
    No statistical analyses for this end point

    Secondary: Percentage of AD Subjects Having >=4 Points of Reduction in Weekly Averages of Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 4 and 6

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    End point title
    		 Percentage of AD Subjects Having >=4 Points of Reduction in Weekly Averages of Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 4 and 6 [6]
    End point description
    The PP-NRS was a daily patient-reported assessment of intensity of pruritus on an 11-point numerical rating scale, ranging from 0 (‘No Itch) to 10 (‘Worst Itch Imaginable’) with a 24 hour recall period. For the PP-NRS score, baseline was defined as the average of all values recorded between Day -7 and Day -1. In this OM, percentages of AD subjects with >=4 points of reduction in weekly averages of PP-NRS from baseline are reported (percentage based on number of subjects with baseline >=4). Analysis population included all subjects who received at least 1 dose of study treatment with PP-NRS baseline >=4. For this end point, data collection was not planned for the 2 arms of Psoriasis Vehicle QD and Psoriasis PF-07038124 0.01% QD.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 1, 2, 4 and 6
    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: This endpoint was summarized for specified reporting arms only.
    End point values
    		 AD Vehicle Once Daily (QD) AD PF-07038124 0.01% QD
    Number of subjects analysed
    29
    34
    Units: Percentage of Subjects
    number (confidence interval 90%)
        Week 1
    0 (0.0 to 9.4)
    8.8 (3.3 to 19.7)
        Week 2
    3.4 (0.4 to 14.5)
    23.5 (12.3 to 37.7)
        Week 4
    6.9 (1.8 to 20.0)
    41.2 (26.9 to 56.7)
        Week 6
    13.8 (6.2 to 27.9)
    41.2 (26.9 to 56.7)
    No statistical analyses for this end point

    Secondary: Change From Baseline in EASI Total Score at Weeks 1, 2, 4, 6 and FUP/EOS for AD Participants

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    End point title
    		 Change From Baseline in EASI Total Score at Weeks 1, 2, 4, 6 and FUP/EOS for AD Participants [7]
    End point description
    EASI evaluated severity of subjects’ AD based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD scored on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, where higher scores = greater severity of AD. Analysis population included all subjects who received at least 1 dose of study treatment. For this end point, data collection was not planned for the 2 arms of Psoriasis Vehicle QD and Psoriasis PF-07038124 0.01% QD.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)
    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: This endpoint was summarized for specified reporting arms only.
    End point values
    		 AD Vehicle Once Daily (QD) AD PF-07038124 0.01% QD
    Number of subjects analysed
    34 [8]
    36 [9]
    Units: Units on a Scale
    least squares mean (confidence interval 90%)
        Week 1
    -1.7 (-2.59 to -0.85)
    -3.4 (-4.28 to -2.59)
        Week 2
    -2.4 (-3.42 to -1.45)
    -5.6 (-6.51 to -4.66)
        Week 4
    -2.5 (-3.63 to -1.31)
    -7.0 (-8.06 to -5.90)
        Week 6
    -3.3 (-4.59 to -1.93)
    -8.2 (-9.39 to -6.94)
        FUP/EOS
    -2.8 (-4.26 to -1.39)
    -6.9 (-8.19 to -5.54)
    Notes
    [8] - Numbers of subjects analyzed for Week 2, Week 4, Week 6 and FUP/EOS were 30, 28, 30 and 27.
    [9] - Numbers of subjects analyzed for Week 4, Week 6 and FUP/EOS were 35, 34 and 32, respectively.
    No statistical analyses for this end point

    Secondary: Percentage of AD Subjects Achieving IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6 and FUP/EOS

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    End point title
    		 Percentage of AD Subjects Achieving IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6 and FUP/EOS [10]
    End point description
    IGA assessed severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions, just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Analysis population included all subjects who received at least 1 dose of study treatment. For this end point, data collection was not planned for the 2 arms of Psoriasis Vehicle QD and Psoriasis PF-07038124 0.01% QD.
    End point type
    Secondary
    End point timeframe
    Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)
    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: This endpoint was summarized for specified reporting arms only.
    End point values
    		 AD Vehicle Once Daily (QD) AD PF-07038124 0.01% QD
    Number of subjects analysed
    34 [11]
    36
    Units: Percentage of Subjects
    number (confidence interval 90%)
        Week 1
    2.9 (0.3 to 12.3)
    11.1 (4.9 to 22.9)
        Week 2
    9.1 (3.4 to 20.2)
    36.1 (22.9 to 50.0)
        Week 4
    14.7 (7.3 to 26.9)
    44.4 (30.2 to 59.1)
        Week 6
    17.6 (8.0 to 30.7)
    52.8 (38.0 to 67.2)
        FUP/EOS
    5.9 (1.6 to 16.9)
    38.9 (25.4 to 53.0)
    Notes
    [11] - Number of subjects analyzed for Week 2 was 33.
    No statistical analyses for this end point

    Secondary: Percentage of Psoriasis Subjects with Physician Global Assessment (PGA) Score Clear (0) or Almost Clear (1) (on a 5-Point Scale) and >=2 Points Improvement From Baseline at Week 6

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    End point title
    		 Percentage of Psoriasis Subjects with Physician Global Assessment (PGA) Score Clear (0) or Almost Clear (1) (on a 5-Point Scale) and >=2 Points Improvement From Baseline at Week 6 [12]
    End point description
    The PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). In this end point, percentages of subjects with a PGA score of 0 or 1 and an improvement of >=2 from Baseline in PGA score are reported. Analysis population included all subjects who received at least 1 dose of study treatment. For this end point, data collection was not planned for the 2 arms of AD Vehicle QD and AD PF-07038124 0.01% QD.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 6
    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: This endpoint was summarized for specified reporting arms only.
    End point values
    		 Psoriasis Vehicle QD Psoriasis PF-07038124 0.01% QD
    Number of subjects analysed
    17
    17
    Units: Percentage of Subjects
        number (confidence interval 90%)
    5.9 (0.6 to 22.5)
    17.6 (6.7 to 36.4)
    No statistical analyses for this end point

    Secondary: Percentage of Psoriasis Subjects Achieving PASI 75 (75% or Greater Improvement From Baseline) at Weeks 1, 2, 4, 6 and FUP/EOS

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    End point title
    		 Percentage of Psoriasis Subjects Achieving PASI 75 (75% or Greater Improvement From Baseline) at Weeks 1, 2, 4, 6 and FUP/EOS [13]
    End point description
    The PASI quantified the severity of a subject's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI was a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score could vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline. Analysis population included all subjects who received at least 1 dose of study treatment. For this end point, data collection was not planned for the 2 arms of AD Vehicle QD and AD PF-07038124 0.01% QD.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)
    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: This endpoint was summarized for specified reporting arms only.
    End point values
    		 Psoriasis Vehicle QD Psoriasis PF-07038124 0.01% QD
    Number of subjects analysed
    17
    17
    Units: Percentage of Subjects
    number (confidence interval 90%)
        Week 1
    0 (0.0 to 14.0)
    5.9 (0.6 to 22.5)
        Week 2
    0 (0.0 to 14.0)
    5.9 (0.6 to 22.5)
        Week 4
    0 (0.0 to 14.0)
    17.6 (6.7 to 36.4)
        Week 6
    5.9 (0.6 to 22.5)
    35.3 (17.5 to 56.8)
        FUP/EOS
    0 (0.0 to 14.0)
    23.5 (10.7 to 43.2)
    No statistical analyses for this end point

    Secondary: Percentage of Psoriasis Subjects Who Achieved a Psoriasis Symptoms Inventory (PSI) Score of 0 (Not at All) or 1 (Mild) on Every Item at Weeks 1, 2, 4, 6 and FUP/EOS

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    End point title
    		 Percentage of Psoriasis Subjects Who Achieved a Psoriasis Symptoms Inventory (PSI) Score of 0 (Not at All) or 1 (Mild) on Every Item at Weeks 1, 2, 4, 6 and FUP/EOS [14]
    End point description
    PSI was a self-administered 8 item questionnaire that measured the severity of psoriasis symptoms over the past 24 hours and the past 7 days. The measure included concepts of itch, pain, burning, stinging, cracking, scaling, flaking, and redness. Subjects were asked to respond to each item using a 5 point Likert response scale: 0: not all severe, 1: mild, 2: moderate, 3: severe and 4: very severe. In this end point, percentages of subjects with a PSI score of 0 or 1 on every item at weeks 1, 2, 4, 6 and FUP/EOS are reported. Analysis population included all subjects who received at least 1 dose of study treatment. For this end point, data collection was not planned for the 2 arms of AD Vehicle QD and AD PF-07038124 0.01% QD.
    End point type
    Secondary
    End point timeframe
    Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)
    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: This endpoint was summarized for specified reporting arms only.
    End point values
    		 Psoriasis Vehicle QD Psoriasis PF-07038124 0.01% QD
    Number of subjects analysed
    17
    17 [15]
    Units: Percentage of Subjects
    number (confidence interval 90%)
        Week 1
    0 (0.0 to 14.0)
    11.8 (3.2 to 31.1)
        Week 2
    5.9 (0.6 to 22.5)
    18.8 (7.1 to 39.1)
        Week 4
    23.5 (10.7 to 43.2)
    43.8 (23.5 to 66.7)
        Week 6
    29.4 (14.0 to 50.0)
    58.8 (36.4 to 77.5)
        FUP/EOS
    41.2 (22.5 to 63.6)
    41.2 (22.5 to 63.6)
    Notes
    [15] - Numbers of subjects analyzed for Week 2 and Week 4 were both 16.
    No statistical analyses for this end point

    Secondary: Change From Baseline in PASI Scores at Weeks 1, 2, 4 and FUP/EOS

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    End point title
    		 Change From Baseline in PASI Scores at Weeks 1, 2, 4 and FUP/EOS [16]
    End point description
    Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90–100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease, where higher scores = greater severity of psoriasis. Analysis population included all subjects who received at least 1 dose of study treatment. For this end point, data collection was not planned for the 2 arms of AD Vehicle QD and AD PF-07038124 0.01% QD.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 1, 2, 4 and FUP/EOS (28-35 days post-last dose)
    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: This endpoint was summarized for specified reporting arms only.
    End point values
    		 Psoriasis Vehicle QD Psoriasis PF-07038124 0.01% QD
    Number of subjects analysed
    17 [17]
    17 [18]
    Units: Units on a Scale
    least squares mean (confidence interval 90%)
        Week 1
    -0.6 (-1.23 to 0.03)
    -1.9 (-2.50 to -1.24)
        Week 2
    -0.7 (-1.51 to 0.11)
    -3.2 (-3.97 to -2.35)
        Week 4
    -0.1 (-1.49 to 1.19)
    -4.1 (-5.44 to -2.80)
        FUP/EOS
    0.2 (-1.59 to 1.97)
    -3.7 (-5.35 to -2.00)
    Notes
    [17] - Numbers of subjects analyzed for Week 4 and FUP/EOS were 16 and 13, respectively.
    [18] - Number of subjects analyzed for FUP/EOS was 15.
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6 and FUP/EOS

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    End point title
    		 Percent Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6 and FUP/EOS [19]
    End point description
    Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90–100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease, where higher scores = greater severity of psoriasis. Analysis population included all subjects who received at least 1 dose of study treatment. For this end point, data collection was not planned for the 2 arms of AD Vehicle QD and AD PF-07038124 0.01% QD.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)
    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: This endpoint was summarized for specified reporting arms only.
    End point values
    		 Psoriasis Vehicle QD Psoriasis PF-07038124 0.01% QD
    Number of subjects analysed
    17 [20]
    17 [21]
    Units: Percent Change
    least squares mean (confidence interval 90%)
        Week 1
    -6.8 (-15.28 to 1.78)
    -25.6 (-34.11 to -17.04)
        Week 2
    -9.0 (-19.14 to 1.09)
    -37.8 (-47.92 to -27.68)
        Week 4
    -9.0 (-22.73 to 4.73)
    -49.4 (-62.93 to -35.79)
        Week 6
    -5.4 (-21.35 to 10.65)
    -58.1 (-73.52 to -42.70)
        FUP/EOS
    -8.4 (-27.02 to 10.25)
    -45.6 (-63.02 to -28.10)
    Notes
    [20] - Numbers of subjects analyzed for Week 4, Week 6 and FUP/EOS were 16, 14 and 13, respectively.
    [21] - Number of subjects analyzed for FUP/EOS was 15.
    No statistical analyses for this end point

    Secondary: Percentage of Psoriasis Subjects With PGA Score Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6 and FUP/EOS

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    End point title
    		 Percentage of Psoriasis Subjects With PGA Score Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6 and FUP/EOS [22]
    End point description
    The PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). In this end point, percentages of subjects with a PGA score of 0 or 1 are reported. Analysis population included all subjects who received at least 1 dose of study treatment. For this end point, data collection was not planned for the 2 arms of AD Vehicle QD and AD PF-07038124 0.01% QD.
    End point type
    Secondary
    End point timeframe
    Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)
    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: This endpoint was summarized for specified reporting arms only.
    End point values
    		 Psoriasis Vehicle QD Psoriasis PF-07038124 0.01% QD
    Number of subjects analysed
    17
    17
    Units: Percentage of Subjects
    number (confidence interval 90%)
        Week 1
    0 (0.0 to 14.0)
    11.8 (3.2 to 31.1)
        Week 2
    0 (0.0 to 14.0)
    17.6 (6.7 to 36.4)
        Week 4
    0 (0.0 to 14.0)
    23.5 (10.7 to 43.2)
        Week 6
    5.9 (0.6 to 22.5)
    23.5 (10.7 to 43.2)
        FUP/EOS
    11.8 (3.2 to 31.1)
    17.6 (6.7 to 36.4)
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6 and FUP/EOS

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    End point title
    		 Percent Change From Baseline in affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6 and FUP/EOS
    End point description
    Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD. Analysis population included all subjects who received at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)
    End point values
    		 AD Vehicle Once Daily (QD) AD PF-07038124 0.01% QD Psoriasis Vehicle QD Psoriasis PF-07038124 0.01% QD
    Number of subjects analysed
    34 [23]
    36 [24]
    17 [25]
    17 [26]
    Units: Percent Change
    least squares mean (confidence interval 90%)
        Week 1
    -6.6 (-13.56 to 0.44)
    -20.2 (-27.01 to -13.44)
    2.5 (-5.50 to 10.49)
    -14.5 (-22.46 to -6.56)
        Week 2
    -10.5 (-19.71 to -1.27)
    -32.2 (-40.83 to -23.62)
    7.2 (-2.68 to 17.17)
    -13.8 (-23.70 to -3.91)
        Week 4
    -2.9 (-15.80 to 9.94)
    -43.9 (-55.73 to -32.00)
    19.8 (3.80 to 35.79)
    -24.7 (-40.52 to -8.89)
        Week 6
    -4.9 (-23.07 to 13.28)
    -61.2 (-78.01 to -44.42)
    29.0 (4.46 to 53.46)
    -32.6 (-56.32 to -8.84)
        FUP/EOS
    -5.1 (-20.70 to 10.56)
    -48.7 (-63.05 to -34.27)
    15.8 (-12.26 to 43.76)
    -31.9 (-58.60 to -5.21)
    Notes
    [23] - Numbers of subjects analyzed for Week 2, Week 4, Week 6 and FUP/EOS were 30, 28, 30, and 27.
    [24] - Numbers of subjects analyzed for Week 4, Week 6 and FUP/EOS were 35, 34 and 32, respectively.
    [25] - Numbers of subjects analyzed for Week 4, Week 6 and FUP/EOS were 16, 14 and 13, respectively.
    [26] - Number of subjects analyzed for FUP/EOS was 15.
    No statistical analyses for this end point

    Secondary: Number of Subjects With All-Causality Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

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    End point title
    		 Number of Subjects With All-Causality Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
    End point description
    An adverse event (AE) was any untoward medical occurrence in a clinical investigation where subjects administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state. An SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or resulted in congenital anomaly/birth defect.
    End point type
    Secondary
    End point timeframe
    Day 1 through Week 6
    End point values
    		 AD Vehicle Once Daily (QD) AD PF-07038124 0.01% QD Psoriasis Vehicle QD Psoriasis PF-07038124 0.01% QD
    Number of subjects analysed
    34
    36
    17
    17
    Units: Subjects
        Subjects With All-Causality TEAEs
    9
    9
    6
    3
        Subjects With All-Causality SAEs
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Vital Signs Data Meeting Pre-defined Criteria

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    End point title
    		 Number of Subjects With Vital Signs Data Meeting Pre-defined Criteria
    End point description
    Abnormality in vital signs: increase and decrease of change of supine diastolic blood pressure (SDBP) from baseline >=20 mmHg, supine systolic blood pressure (SSBP) <90 mmHg, and increase in change of SSBP from baseline >=30 mmHg. Analysis population included all subjects evaluated against criteria.
    End point type
    Secondary
    End point timeframe
    Day 1 through Week 6
    End point values
    		 AD Vehicle Once Daily (QD) AD PF-07038124 0.01% QD Psoriasis Vehicle QD Psoriasis PF-07038124 0.01% QD
    Number of subjects analysed
    34
    36
    17
    16
    Units: Subjects
        Change of SDBP >=20 mmHg Increase
    2
    1
    0
    2
        Change of SDBP >=20 mmHg Decrease
    1
    0
    0
    0
        Value of SSBP <90 mmHg
    0
    0
    0
    1
        Change of SSBP >=30 mmHg Increase
    1
    1
    1
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria

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    End point title
    		 Number of Subjects With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria
    End point description
    ECG abnormalities criteria included: value of PR interval >=300 msec, percent change of PR interval >=25/50% and change of corrected QT interval using Fridericia’s Formula (QTcF) >=30 msec and <60 msec. Analysis population included all subjects evaluated against criteria.
    End point type
    Secondary
    End point timeframe
    Day 1 through Week 6
    End point values
    		 AD Vehicle Once Daily (QD) AD PF-07038124 0.01% QD Psoriasis Vehicle QD Psoriasis PF-07038124 0.01% QD
    Number of subjects analysed
    27
    33
    13
    15
    Units: Subjects
        Value of PR Interval >=300 msec
    0
    1
    0
    0
        Percent Change of PR Interval >=25/50%
    0
    0
    1
    0
        Change of Corrected QTcF >=30 msec and <60 msec
    3
    0
    0
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects With Laboratory Test Abnormalities

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    End point title
    		 Number of Subjects With Laboratory Test Abnormalities
    End point description
    Laboratory parameters included: hematology (hemoglobin, hematocrit, red blood cell, platelet and white blood cell count, neutrophils, eosinophils, monocytes, basophils and lymphocytes), chemistry (blood urea nitrogen, creatinine, sodium, potassium, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein and serum pregnancy test [for all female subjects]) and urine (urine pregnancy test [for all female subjects]). Analysis population included subjects with at least 1 observation of the given laboratory test while on study treatment or during lag time.
    End point type
    Secondary
    End point timeframe
    Day 1 through Week 6
    End point values
    		 AD Vehicle Once Daily (QD) AD PF-07038124 0.01% QD Psoriasis Vehicle QD Psoriasis PF-07038124 0.01% QD
    Number of subjects analysed
    34 [27]
    36 [28]
    17 [29]
    17 [30]
    Units: Subjects
        Hemoglobin <0.8 × LLN
    0
    1
    0
    0
        Ery. Mean Corpuscular Volume <0.9 × LLN
    0
    1
    0
    0
        Ery. Mean Corpuscular Hemoglobin <0.9 × LLN
    0
    1
    0
    0
        Leukocytes >1.5 × ULN
    0
    0
    0
    1
        Lymphocytes <0.8 × LLN
    1
    0
    0
    0
        Lymphocytes >1.2 × ULN
    0
    1
    0
    0
        Lymphocytes/Leukocytes <0.8 × LLN
    3
    2
    2
    1
        Lymphocytes/Leukocytes >1.2 × ULN
    1
    0
    0
    0
        Neutrophils <0.8 × LLN
    2
    0
    0
    0
        Neutrophils >1.2 × ULN
    0
    1
    1
    1
        Neutrophils/Leukocytes <0.8 × LLN
    1
    1
    0
    0
        Basophils/Leukocytes >1.2 × ULN
    0
    0
    0
    1
        Eosinophils >1.2 × ULN
    2
    1
    0
    1
        Eosinophils/Leukocytes >1.2 × ULN
    3
    4
    0
    1
        Monocytes >1.2 × ULN
    0
    1
    0
    0
        Monocytes/Leukocytes >1.2 × ULN
    0
    2
    0
    1
        Potassium >1.1 × ULN
    0
    0
    2
    1
        Bicarbonate <0.9 × LLN
    2
    0
    1
    0
        Glucose >1.5 × ULN
    2
    3
    4
    1
        Fibrinogen >1.25 × ULN
    3
    11
    4
    1
        URINE Glucose >=1
    2
    2
    1
    0
        Ketones >=1
    0
    2
    1
    3
        URINE Protein >=1
    1
    0
    0
    1
        URINE Hemoglobin >=1
    4
    4
    2
    2
        URINE Bilirubin >=1
    0
    0
    1
    0
        Nitrite >=1
    2
    0
    0
    0
        Leukocyte Esterase >=1
    3
    9
    5
    3
        URINE Erythrocytes (/HPF) >=20
    2
    1
    0
    3
        URINE Leukocytes (/HPF) >=20
    0
    1
    2
    2
        Hyaline Casts (/LPF) >1
    0
    3
    2
    0
    Notes
    [27] - Numbers of subjects analyzed for URINE Erythrocytes/Leukocytes and Hyaline Casts were 15, 18 and 0.
    [28] - Numbers of subjects analyzed for URINE Erythrocytes/ Leukocytes and Hyaline Casts were 16, 20 and 4.
    [29] - Numbers of subjects analyzed for URINE Erythrocytes/Leukocytes and Hyaline Casts were 12, 13 and 2.
    [30] - Numbers of subjects analyzed for URINE Erythrocytes/Leukocytes and Hyaline Casts were 8, 10 and 0.
    No statistical analyses for this end point

    Secondary: Number of Subjects With Different Severity Grades in Skin Tolerability at Day 1, Weeks 1, 2, 4, 6, Early Termination (ET) and FUP

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    End point title
    		 Number of Subjects With Different Severity Grades in Skin Tolerability at Day 1, Weeks 1, 2, 4, 6, Early Termination (ET) and FUP
    End point description
    The investigator or designee assessed tolerability at the site of investigational product application (pre-dose and immediately post-dose). This assessment focused on the treated non-lesional skin using the scale: none = no evidence of local intolerance; mild = minimal erythema and/or oedema, slight glazed appearance; moderate = definite erythema and/or oedema with peeling and/or cracking but needs no adaptation of posology; severe (to be reported as an AE) = erythema, oedema glazing with fissures, few vesicles or papules: consider removing topical agent (if still in place); very severe (to be reported as an AE) = strong reaction spreading beyond the treated area, bullous reaction, erosions: removal of topical agent (if still in place). Analysis population included all subjects who received at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    Day 1, Weeks 1, 2, 4, 6, ET and FUP (28-35 days post-last dose)
    End point values
    		 AD Vehicle Once Daily (QD) AD PF-07038124 0.01% QD Psoriasis Vehicle QD Psoriasis PF-07038124 0.01% QD
    Number of subjects analysed
    34
    36
    17
    17
    Units: Subjects
        Day 1 None
    33
    35
    17
    17
        Day 1 Mild
    0
    1
    0
    0
        Day 1 Moderate
    1
    0
    0
    0
        Day 1 Severe
    0
    0
    0
    0
        Day 1 Very Severe
    0
    0
    0
    0
        Week 1 None
    25
    33
    17
    16
        Week 1 Mild
    4
    3
    0
    0
        Week 1 Moderate
    2
    0
    0
    1
        Week 1 Severe
    0
    0
    0
    0
        Week 1 Very Severe
    0
    0
    0
    0
        Week 2 None
    26
    34
    15
    16
        Week 2 Mild
    1
    2
    0
    0
        Week 2 Moderate
    1
    0
    1
    1
        Week 2 Severe
    0
    0
    0
    0
        Week 2 Very Severe
    0
    0
    0
    0
        Week 4 None
    22
    32
    13
    16
        Week 4 Mild
    4
    2
    1
    0
        Week 4 Moderate
    1
    0
    0
    0
        Week 4 Severe
    0
    0
    0
    0
        Week 4 Very Severe
    0
    0
    0
    0
        Week 6 None
    24
    33
    11
    14
        Week 6 Mild
    3
    0
    0
    1
        Week 6 Moderate
    0
    0
    2
    0
        Week 6 Severe
    0
    0
    0
    0
        Week 6 Very Severe
    0
    0
    0
    0
        ET None
    3
    2
    3
    1
        ET Mild
    1
    0
    0
    0
        ET Moderate
    1
    0
    0
    1
        ET Severe
    2
    0
    0
    0
        ET Very Severe
    0
    0
    0
    0
        FUP None
    25
    29
    12
    15
        FUP Mild
    1
    1
    1
    0
        FUP Moderate
    1
    0
    1
    1
        FUP Severe
    0
    0
    0
    0
        FUP Very Severe
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 through Week 6
    Adverse event reporting additional description
    The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 subject and as non-serious in another subject, or 1 subject may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of subjects evaluable for SAEs or AEs.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    AD Vehicle QD
    Reporting group description
    		 Subjects in AD group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.

    Reporting group title
    AD PF-07038124 0.01% QD
    Reporting group description
    		 Subjects in AD group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.

    Reporting group title
    Psoriasis Vehicle QD
    Reporting group description
    		 Subjects in plaque psoriasis group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.

    Reporting group title
    Psoriasis PF-07038124 0.01% QD
    Reporting group description
    		 Subjects in plaque psoriasis group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.

    Serious adverse events
    		 AD Vehicle QD AD PF-07038124 0.01% QD Psoriasis Vehicle QD Psoriasis PF-07038124 0.01% QD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 36 (0.00%)
    0 / 17 (0.00%)
    0 / 17 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 AD Vehicle QD AD PF-07038124 0.01% QD Psoriasis Vehicle QD Psoriasis PF-07038124 0.01% QD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 34 (17.65%)
    1 / 36 (2.78%)
    6 / 17 (35.29%)
    3 / 17 (17.65%)
    Investigations
    Blood glucose increased
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 36 (0.00%)
    1 / 17 (5.88%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    SARS-CoV-2 test positive
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 36 (0.00%)
    1 / 17 (5.88%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Injury, poisoning and procedural complications
    Muscle strain
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 36 (0.00%)
    0 / 17 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 36 (0.00%)
    1 / 17 (5.88%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    General disorders and administration site conditions
    Application site pruritus
         subjects affected / exposed
    2 / 34 (5.88%)
    0 / 36 (0.00%)
    0 / 17 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    4
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Sinus congestion
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 36 (0.00%)
    0 / 17 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    3 / 34 (8.82%)
    1 / 36 (2.78%)
    0 / 17 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    3
    1
    0
    0
    Pruritus
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 36 (0.00%)
    1 / 17 (5.88%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Psoriasis
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 36 (0.00%)
    2 / 17 (11.76%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Psychiatric disorders
    Suicidal ideation
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 36 (0.00%)
    1 / 17 (5.88%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 36 (0.00%)
    1 / 17 (5.88%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Back pain
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 36 (0.00%)
    0 / 17 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    1
    Infections and infestations
    Herpes zoster
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 36 (0.00%)
    0 / 17 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    1
    Urinary tract infection
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 36 (0.00%)
    1 / 17 (5.88%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 36 (0.00%)
    1 / 17 (5.88%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hyperkalaemia
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 36 (0.00%)
    1 / 17 (5.88%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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