Skip to content

A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis.

A PHASE 2B, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED, PARALLEL GROUP STUDY TO ASSESS THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF MULTIPLE DOSE LEVELS OF PF-07038124 OINTMENT FOR 12 WEEKS IN PARTICIPANTS 12 YEARS AND OLDER AND WITH MILD-TO-MODERATE ATOPIC DERMATITIS OR MILD-TO-SEVERE PLAQUE PSORIASIS

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05375955
Enrollment
263
Registered
2022-05-17
Start date
2022-09-26
Completion date
2023-07-31
Last updated
2024-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis, Plaque Psoriasis

Keywords

Eczema, topical

Brief summary

The purpose of this clinical trial is to learn about the safety, how well the study medicine works, extent to which side effects can be tolerated, and how the study medicine is changed and eliminated from your body after you apply it on your skin. The study medicine is in ointment form. This study is seeking participants who If they have Atopic Dermatitis (AD): * Have a diagnosis for at least 3 months * Have a diagnosis of mild or moderate disease assessed using Investigator's Global Assessment (IGA) * Have percent Body Surface Area (%BSA) covering 5% up to 40% * A Peak Pruritus Numerical Rating Scale (PP-NRS) average score of ≥2 during the screening period If they have plaque psoriasis (PsO): * Have a diagnosis for at least 6 months * Have a diagnosis of mild, moderate, or severe disease assessed using Physician's Global Assessment (PGA) * Have percent Body Surface Area (%BSA) covering 2% up to 20% All participants in this study will receive either 0.01% PF-07038124, 0.03% PF-07038124, or a vehicle ointment. In addition, some participants with PsO will receive 0.06% PF- PF-07038124. Participants will not know which dose level they have received. The participants will be randomly assigned to each dose group. PF-07038124 ointment will be applied topically to affected areas once daily. We will compare the experiences of people receiving the different dose levels of the ointment to those who receive the vehicle ointment. This will help us determine if PF-07038124 ointment is safe and effective. Participants will take part in this study for approximately 21 weeks. Participants will apply the study medicine once daily for 12 weeks followed by a safety follow-up period of 4-5 weeks from last application of study medicine to last visit.

Interventions

DRUGPF-07038124 ointment 0.01%

Atopic Dermatitis and Plaque Psoriasis

Atopic Dermatitis and Plaque Psoriasis

DRUGPF-07038124 ointment 0.03%

Atopic Dermatitis and Plaque Psoriasis

DRUGPF-07038124 ointment 0.06%

PF-07038124 ointment 0.06% (Plaque Psoriasis only)

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No

Inclusion criteria

for AD population: * Diagnosis of Atopic Dermatitis (AD) for at least 3 months * Investigator's Global Assessment (IGA) score of 2 (mild), or 3 (moderate) * AD covering 5% and up to 40% of Body Surface Area (BSA) * A Peak Pruritus Numerical Rating Scale (PP-NRS) average score of ≥2 Inclusion Criteria for Plaque Psoriasis * Diagnosis of Plaque Psoriasis (PsO) for at least 6 months * Physician Global Assessment (PGA) score of 2 (mild), 3 (moderate), or 4 (severe) * PsO covering 2% to 20% (inclusive) of BSA

Exclusion criteria

* Presence of skin comorbidities that would interfere with study assessment or response to treatment * Psychiatric condition including recent or active suicidal ideation or behavior * Current or recent history of severe, progressive, or uncontrolled disease * A history of systemic, chronic or acute skin infection requiring hospitalization, parenteral antimicrobial therapy, or is judged clinically significant. * Recent, significant trauma or major surgery * History of cancer or have undergone treatment for any type of cancer, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ with no evidence of recurrence. * History of angioedema or anaphylaxis to topical products or known sensitivity to any of the components of the investigational products. * Use of any prohibited concomitant medication(s) * Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). * Participants with an estimated glomerular filtration rate (eGFR) of \<40 mL/min/1.73m2 calculated using the serum creatinine-based Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) formula for adults and serum creatinine \>1.5 x upper limit of normal (ULN) in adolescents (12-18 years old) * Participants with total bilirubin ≥2x ULN (≥3 x ULN for Gilbert's disease), aspartate aminotransferase (AST) ≥2.5 x ULN, ALT ≥2.5 x ULN. * Clinically relevant abnormal baseline standard 12-lead electrocardiogram (ECG) including, but not limited to QTC corrected using Fridericia's Formula (QTcF) interval \>450 msec and QRS \> 120 msec * A recent history of alcohol or substance abuse

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants With Investigator's Global Assessment (IGA) Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of More Than or Equal to (>=) 2 Points at Week 12: Participants With Atopic Dermatitis (AD) OnlyBaseline, Week 12IGA assessed severity of AD on 5-point scale ranging from 0(clear)to 4(severe)higher scores indicate more severity,reflecting a global consideration of erythema (ery),induration and scaling. Clinical evaluator assessed overall severity of AD and assigned IGA score as follows: 0 (clear) no inflammatory signs of AD; 1=almost clear, AD not fully cleared-light pink residual lesions(except post-inflammatory hyperpigmentation),just perceptible ery, papulation/induration lichenification, excoriation, no oozing/crusting; 2=mild AD with light red lesions, slight but definite ery, papulation/induration, lichenification, excoriation, no oozing/crusting; 3=moderate AD with red lesions, moderate ery, papulation/induration, lichenification, excoriation, slight oozing/crusting; 4=severe AD with deep dark red lesions, severe ery, papulation/induration, lichenification, excoriation, moderate to severe oozing/crusting.95 percentage (%)confidence interval was based on Blyth-Still-Casella method.
Percentage of Participants With Physician's Global Assessment (PGA) Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Week 12: Participants With Plaque Psoriasis OnlyBaseline, Week 12The 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 OM, percentages of participants with a PGA score of 0 or 1 and an improvement of \>=2 from Baseline in PGA score were reported. 95% confidence interval (CI) was based on Blyth-Still-Casella method.

Secondary

MeasureTime frameDescription
Percentage of Participants With IGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >= 2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Atopic Dermatitis OnlyBaseline, Week 1, 2, 4, 6, 8, and 10IGA assessed severity of AD on 5-point scale ranging from 0(clear)to 4(severe)higher scores indicate more severity,reflecting a global consideration of erythema (ery),induration and scaling. Clinical evaluator assessed overall severity of AD and assigned IGA score as follows: 0 (clear) no inflammatory signs of AD; 1=almost clear, AD not fully cleared-light pink residual lesions(except post-inflammatory hyperpigmentation),just perceptible ery, papulation/induration lichenification, excoriation, no oozing/crusting; 2=mild AD with light red lesions, slight but definite ery, papulation/induration, lichenification, excoriation, no oozing/crusting; 3=moderate AD with red lesions, moderate ery, papulation/induration, lichenification, excoriation, slight oozing/crusting; 4=severe AD with deep dark red lesions, severe ery, papulation/induration, lichenification, excoriation, moderate to severe oozing/crusting.95%confidence interval was based on Blyth-Still-Casella method.
Percentage of Participants With PGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Plaque Psoriasis OnlyBaseline, Week 1, 2, 4, 6, 8, and 10The 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 OM, percentages of participants with a PGA score of 0 or 1 and an improvement of \>=2 from Baseline in PGA score were reported. 95% confidence interval was based on Blyth-Still-Casella method.
Percentage of Participants With IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 1, 2, 4, 6, 8, 10 and 12IGA assessed severity of AD on 5-point scale ranging from 0(clear)to 4(severe)higher scores indicate more severity,reflecting a global consideration of erythema (ery),induration and scaling. Clinical evaluator assessed overall severity of AD and assigned IGA score as follows: 0 (clear) no inflammatory signs of AD; 1=almost clear, AD not fully cleared-light pink residual lesions(except post-inflammatory hyperpigmentation),just perceptible ery, papulation/induration lichenification, excoriation, no oozing/crusting; 2=mild AD with light red lesions, slight but definite ery, papulation/induration, lichenification, excoriation, no oozing/crusting; 3=moderate AD with red lesions, moderate ery, papulation/induration, lichenification, excoriation, slight oozing/crusting; 4=severe AD with deep dark red lesions, severe ery, papulation/induration, lichenification, excoriation, moderate to severe oozing/crusting. 95% confidence interval was based on Blyth-Still-Casella method.
Percentage of Participants With PGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 1, 2, 4, 6, 8, 10 and 12The 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). 95% confidence interval was based on Blyth-Still-Casella method.
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyBaseline, Week 1, 2, 4, 6, 8, 10 and 12EASI quantified severity of AD based on severity of lesion clinical signs and percentage (%) of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema \[E\], induration/papulation \[I\], excoriation \[Ex\] and lichenification \[L\]) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % 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; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score=0.0 to 72.0, higher scores indicate greater severity of AD. 95% confidence interval was based on Blyth-Still-Casella method.
Change From Baseline in Psoriasis Area and Severity Index (PASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyBaseline, Week 1, 2, 4, 6, 8, 10 and 12The PASI quantified the severity of a participant'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 =0.1Ah(Eh+Ih+Sh) + 0.2Au(Eu+Iu+Su) + 0.3At(Et+It+St) + 0.4Al(El+Il+Sl) (A= PASI area score,S=scaling)PASI 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline. 95% confidence interval was based on Blyth-Still-Casella method.
Percentage of Participants With >= 4 Points of Reduction From Baseline in Weekly Average of Peak Pruritus Numerical Rating Scale (PP-NRS) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyBaseline, Week 1, 2, 4, 6, 8, 10 and 12The PP-NRS was a daily participant 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. Participants were asked to assess their itch intensity over the past 24 hours, on a scale from 0 (no itching) to 10 (worst possible itching). Higher scores indicated worse itch. For the PP-NRS score, baseline was defined as the average of all values recorded between Day -7 (7 days prior to dosing) and Day -1 (1 day prior to dosing). In this OM, percentages of AD participants with \>=4 points of reduction in weekly averages of PP-NRS from baseline are reported (percentage based on number of participants with baseline \>=4).
Percentage of Participants With >= 75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Atopic Dermatitis OnlyBaseline, Week 1, 2, 4, 6, 8, 10 and 12EASI quantified severity of AD based on severity of lesion clinical signs and % of body surface area(BSA)affected.Severity of clinical signs of AD lesions (erythema \[E\], induration/papulation\[I\],excoriation\[Ex\] and lichenification\[L\]) were scored separately for each of 4 body regions(head and neck, upper limbs, trunk \[including axillae and groin)\], lower limbs \[including buttocks\]) on a 4-point scale:0= absent; 1= mild;2= moderate;3= severe.EASI area score was based on % 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;h= head and neck;u= upper limbs;t= trunk;l= lower limbs.Total EASI score=0.0 to 72.0, higher scores indicate greater severity of AD.EASI 75 response was defined as at least a 75% reduction in EASI relative to Baseline.95% CI was based on Blyth-Still-Casella method.
Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisBaseline, Week 1, 2, 4, 6, 8, 10 and 12Four 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 (size of participant's hand with fingers in a closed position) 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 percentage (%) BSA for individuals with AD ranged from 5-40 % BSA and for individuals with Psoriasis ranged from 2-20 % BSA. Higher % BSA = greater area affected.
Number of Participants With Treatment Emergent Adverse Events (AEs): Participants With Atopic Dermatitis and Plaque PsoriasisFrom start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered TEAE if the event occurred on or after the first dosing date but before the last dose plus the lag time (35 days).
Number of Participants With Serious Adverse Events (SAEs): Participants With Atopic Dermatitis and Plaque PsoriasisFrom start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)An SAE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or other important medical events.
Number of Participants With Clinically Significant Changes in Vital Signs: Participants With Atopic Dermatitis and Plaque PsoriasisFrom start of study treatment (Day 1) up to Week 12Temperature, pulse rate, and blood pressure were assessed in vital sign examination. Body temperature was collected using oral, tympanic, axillary or temporal methods. Blood pressure and pulse rate measurements were assessed with the participant in a supine or seated position using a completely automated device after at least 5 minutes of rest for the participant. Clinically significant changes were determined by the investigator.
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG): Participants With Atopic Dermatitis and Plaque PsoriasisFrom start of study treatment (Day 1) up to Week 12A standard 12-lead ECG utilizing limb leads was collected using ECG machine that automatically calculated the heart rate and measured pulse rate, QT, and QTc intervals and QRS complex. Clinically significant findings (including, but not limited to, changes from baseline in QTcF after enrollment) were determined by the investigator or qualified designee.
Number of Participants With Laboratory Abnormalities: Participants With Atopic Dermatitis and Plaque PsoriasisFrom start of study treatment (Day 1) up to Week 12Laboratory assessments included hematology, clinical chemistry and urinalysis. Clinically significant abnormal laboratory findings were those which were not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque PsoriasisFrom start of study treatment (Day 1) up to Week 12The investigator or designee assessed tolerability at the site of study intervention application, immediately post-application of the study intervention. Skin Tolerability Grading System for non-lesional skin included grade 0 (No evidence of local intolerance), grade 1 (Mild-Minimal erythema and/or edema, slight glazed appearance), grade 2 (Moderate-Definite erythema and/or edema with peeling and/or cracking but needs no adaptation of posology), grade 3 (Severe-Erythema, edema glazing with fissures, few vesicles or papules: consider removing topical agent \[if still in place\], grade 4 (very severe- Strong reaction spreading beyond the treated area, bullous reaction, erosions: removal of topical agent \[if still in place\].
Percentage of Adult (18-75 Years Old) Participants With >=4 Points of Reduction From Baseline in Weekly Average of PP-NRS at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 1, 2, 4, 6, 8, 10 and 12The PP-NRS was a daily participant 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. Participants were asked to assess their itch intensity over the past 24 hours, on a scale from 0 (no itching) to 10 (worst possible itching). Higher scores indicated worse itch. For the PP-NRS score, baseline was defined as the average of all values recorded between Day -7 (7 days prior to dosing) and Day -1 (1 day prior to dosing). In this OM, percentages of plaque psoriasis participants (18-75 years old) with \>=4 points of reduction in weekly averages of PP-NRS from baseline are reported (percentage based on number of participants with baseline \>=4).
Percentage of Participants With >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Plaque Psoriasis OnlyBaseline, Week 1, 2, 4, 6, 8, 10 and 12The PASI quantified the severity of a participant'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 score =0.1Ah(Eh+Ih+Sh) + 0.2Au(Eu+Iu+Su) + 0.3At(Et+It+St) + 0.4Al(El+Il+Sl) (A= PASI area score,S=scaling)PASI 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline. 95% confidence interval was based on Blyth-Still-Casella method.

Countries

Canada, Japan, United Kingdom, United States

Participant flow

Pre-assignment details

A total of 263 participants were enrolled and randomized in the study.

Participants by arm

ArmCount
Atopic Dermatitis: Vehicle Ointment
Participants with mild or moderate atopic dermatitis applied the vehicle ointment topically on affected areas once daily (QD) for 12 weeks.
44
Atopic Dermatitis: PF-07038124 0.01% Ointment
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
42
Atopic Dermatitis: PF-07038124 0.03% Ointment
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
42
Psoriasis: PF-07038124 Vehicle Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0% ointment topically on affected areas QD for 12 weeks.
34
Psoriasis: PF-07038124 0.01% Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
33
Psoriasis: PF-07038124 0.03% Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
35
Psoriasis: PF-07038124 0.06% Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.06% ointment topically on affected areas QD for 12 weeks.
33
Total263

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006
Follow-up (up to 5 Weeks)Lost to Follow-up1010112
Follow-up (up to 5 Weeks)Other0100000
Follow-up (up to 5 Weeks)Physician's decision2020000
Follow-up (up to 5 Weeks)Protocol Violation0010000
Follow-up (up to 5 Weeks)Withdrawal by Subject1010010
Treatment (12 Weeks)Lost to Follow-up0221110
Treatment (12 Weeks)Other0100000
Treatment (12 Weeks)Physician Decision4130010
Treatment (12 Weeks)Pregnancy0010000
Treatment (12 Weeks)Withdrawal by parent/guardian0000001
Treatment (12 Weeks)Withdrawal by Subject8478433

Baseline characteristics

CharacteristicAtopic Dermatitis: Vehicle OintmentAtopic Dermatitis: PF-07038124 0.01% OintmentAtopic Dermatitis: PF-07038124 0.03% OintmentPsoriasis: PF-07038124 Vehicle OintmentPsoriasis: PF-07038124 0.01% OintmentPsoriasis: PF-07038124 0.03% OintmentPsoriasis: PF-07038124 0.06% OintmentTotal
Age, Continuous44.8 Years
STANDARD_DEVIATION 18.55
44.1 Years
STANDARD_DEVIATION 15.31
40.0 Years
STANDARD_DEVIATION 16.28
52.6 Years
STANDARD_DEVIATION 12.28
47.8 Years
STANDARD_DEVIATION 13.37
55.7 Years
STANDARD_DEVIATION 15.11
50.0 Years
STANDARD_DEVIATION 17.33
51.6 Years
STANDARD_DEVIATION 14.77
Ethnicity (NIH/OMB)
Hispanic or Latino
7 Participants11 Participants8 Participants16 Participants11 Participants7 Participants6 Participants66 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
35 Participants29 Participants32 Participants17 Participants22 Participants25 Participants27 Participants187 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants2 Participants2 Participants1 Participants0 Participants3 Participants0 Participants10 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
8 Participants8 Participants13 Participants7 Participants4 Participants8 Participants12 Participants60 Participants
Race (NIH/OMB)
Black or African American
13 Participants11 Participants12 Participants0 Participants1 Participants2 Participants0 Participants39 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants2 Participants0 Participants1 Participants1 Participants0 Participants1 Participants5 Participants
Race (NIH/OMB)
White
23 Participants20 Participants17 Participants25 Participants27 Participants25 Participants20 Participants157 Participants
Sex: Female, Male
Female
23 Participants25 Participants23 Participants14 Participants13 Participants14 Participants15 Participants127 Participants
Sex: Female, Male
Male
21 Participants17 Participants19 Participants20 Participants20 Participants21 Participants18 Participants136 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
deaths
Total, all-cause mortality
0 / 440 / 420 / 420 / 340 / 330 / 350 / 33
other
Total, other adverse events
0 / 445 / 422 / 421 / 345 / 332 / 357 / 33
serious
Total, serious adverse events
0 / 441 / 421 / 420 / 340 / 330 / 351 / 33

Outcome results

Primary

Percentage of Participants With Investigator's Global Assessment (IGA) Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of More Than or Equal to (>=) 2 Points at Week 12: Participants With Atopic Dermatitis (AD) Only

IGA assessed severity of AD on 5-point scale ranging from 0(clear)to 4(severe)higher scores indicate more severity,reflecting a global consideration of erythema (ery),induration and scaling. Clinical evaluator assessed overall severity of AD and assigned IGA score as follows: 0 (clear) no inflammatory signs of AD; 1=almost clear, AD not fully cleared-light pink residual lesions(except post-inflammatory hyperpigmentation),just perceptible ery, papulation/induration lichenification, excoriation, no oozing/crusting; 2=mild AD with light red lesions, slight but definite ery, papulation/induration, lichenification, excoriation, no oozing/crusting; 3=moderate AD with red lesions, moderate ery, papulation/induration, lichenification, excoriation, slight oozing/crusting; 4=severe AD with deep dark red lesions, severe ery, papulation/induration, lichenification, excoriation, moderate to severe oozing/crusting.95 percentage (%)confidence interval was based on Blyth-Still-Casella method.

Time frame: Baseline, Week 12

Population: Intent-to-treat (ITT) analysis set included all participants randomly assigned to study intervention. For this outcome measure (OM), data collection was not planned for the 4 arms of Psoriasis Vehicle QD, Psoriasis PF-07038124 0.01% QD, Psoriasis PF-07038124 0.03% and Psoriasis PF-07038124 0.06% ointment.

ArmMeasureValue (NUMBER)
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With Investigator's Global Assessment (IGA) Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of More Than or Equal to (>=) 2 Points at Week 12: Participants With Atopic Dermatitis (AD) Only11.4 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With Investigator's Global Assessment (IGA) Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of More Than or Equal to (>=) 2 Points at Week 12: Participants With Atopic Dermatitis (AD) Only23.8 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With Investigator's Global Assessment (IGA) Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of More Than or Equal to (>=) 2 Points at Week 12: Participants With Atopic Dermatitis (AD) Only21.4 Percentage of participants
p-value: 0.071195% CI: [-4.1, 29.4]Chan and Zhang (1999) method
p-value: 0.12995% CI: [-6.1, 26.8]Chan and Zhang (1999) method
Primary

Percentage of Participants With Physician's Global Assessment (PGA) Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Week 12: Participants With Plaque Psoriasis Only

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 OM, percentages of participants with a PGA score of 0 or 1 and an improvement of \>=2 from Baseline in PGA score were reported. 95% confidence interval (CI) was based on Blyth-Still-Casella method.

Time frame: Baseline, Week 12

Population: ITT analysis set included all participants randomly assigned to study intervention. For this OM, data collection was not planned for the 3 arms of AD Vehicle QD, AD PF-07038124 0.01% QD and AD PF-07038124 0.03% QD.

ArmMeasureValue (NUMBER)
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With Physician's Global Assessment (PGA) Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Week 12: Participants With Plaque Psoriasis Only8.8 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With Physician's Global Assessment (PGA) Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Week 12: Participants With Plaque Psoriasis Only15.2 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With Physician's Global Assessment (PGA) Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Week 12: Participants With Plaque Psoriasis Only37.1 Percentage of participants
Psoriasis: PF-07038124 0.06% OintmentPercentage of Participants With Physician's Global Assessment (PGA) Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Week 12: Participants With Plaque Psoriasis Only45.5 Percentage of participants
p-value: 0.271295% CI: [-10.8, 24.3]Chan and Zhang (1999) method
p-value: 0.002895% CI: [7.7, 47.5]Chan and Zhang (1999) method
p-value: 0.000395% CI: [14.7, 56.4]Chan and Zhang (1999) method
Secondary

Change From Baseline in Psoriasis Area and Severity Index (PASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis Only

The PASI quantified the severity of a participant'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 =0.1Ah(Eh+Ih+Sh) + 0.2Au(Eu+Iu+Su) + 0.3At(Et+It+St) + 0.4Al(El+Il+Sl) (A= PASI area score,S=scaling)PASI 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline. 95% confidence interval was based on Blyth-Still-Casella method.

Time frame: Baseline, Week 1, 2, 4, 6, 8, 10 and 12

Population: ITT analysis set included all participants randomly assigned to study intervention. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable for the specified rows. For this OM, data collection was not planned for the 3 arms of AD Vehicle QD, AD PF-07038124 0.01% QD and AD PF-07038124 0.03% QD.

ArmMeasureGroupValue (MEAN)Dispersion
Atopic Dermatitis: Vehicle OintmentChange From Baseline in Psoriasis Area and Severity Index (PASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 1-0.60 Units on a scaleStandard Deviation 1.796
Atopic Dermatitis: Vehicle OintmentChange From Baseline in Psoriasis Area and Severity Index (PASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 10-3.93 Units on a scaleStandard Deviation 3.398
Atopic Dermatitis: Vehicle OintmentChange From Baseline in Psoriasis Area and Severity Index (PASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 8-3.23 Units on a scaleStandard Deviation 3.584
Atopic Dermatitis: Vehicle OintmentChange From Baseline in Psoriasis Area and Severity Index (PASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 2-1.53 Units on a scaleStandard Deviation 2.192
Atopic Dermatitis: Vehicle OintmentChange From Baseline in Psoriasis Area and Severity Index (PASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 12-3.57 Units on a scaleStandard Deviation 3.946
Atopic Dermatitis: Vehicle OintmentChange From Baseline in Psoriasis Area and Severity Index (PASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 4-1.70 Units on a scaleStandard Deviation 3.245
Atopic Dermatitis: Vehicle OintmentChange From Baseline in Psoriasis Area and Severity Index (PASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 6-2.13 Units on a scaleStandard Deviation 3.451
Atopic Dermatitis: PF-07038124 0.01% OintmentChange From Baseline in Psoriasis Area and Severity Index (PASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 10-4.45 Units on a scaleStandard Deviation 3.486
Atopic Dermatitis: PF-07038124 0.01% OintmentChange From Baseline in Psoriasis Area and Severity Index (PASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 6-3.65 Units on a scaleStandard Deviation 2.639
Atopic Dermatitis: PF-07038124 0.01% OintmentChange From Baseline in Psoriasis Area and Severity Index (PASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 4-3.09 Units on a scaleStandard Deviation 2.332
Atopic Dermatitis: PF-07038124 0.01% OintmentChange From Baseline in Psoriasis Area and Severity Index (PASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 8-3.70 Units on a scaleStandard Deviation 3.059
Atopic Dermatitis: PF-07038124 0.01% OintmentChange From Baseline in Psoriasis Area and Severity Index (PASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 12-4.53 Units on a scaleStandard Deviation 3.556
Atopic Dermatitis: PF-07038124 0.01% OintmentChange From Baseline in Psoriasis Area and Severity Index (PASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 2-2.75 Units on a scaleStandard Deviation 2.315
Atopic Dermatitis: PF-07038124 0.01% OintmentChange From Baseline in Psoriasis Area and Severity Index (PASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 1-1.74 Units on a scaleStandard Deviation 1.529
Atopic Dermatitis: PF-07038124 0.03% OintmentChange From Baseline in Psoriasis Area and Severity Index (PASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 6-4.54 Units on a scaleStandard Deviation 3.143
Atopic Dermatitis: PF-07038124 0.03% OintmentChange From Baseline in Psoriasis Area and Severity Index (PASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 1-1.69 Units on a scaleStandard Deviation 2.053
Atopic Dermatitis: PF-07038124 0.03% OintmentChange From Baseline in Psoriasis Area and Severity Index (PASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 2-2.41 Units on a scaleStandard Deviation 2.496
Atopic Dermatitis: PF-07038124 0.03% OintmentChange From Baseline in Psoriasis Area and Severity Index (PASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 4-3.50 Units on a scaleStandard Deviation 2.861
Atopic Dermatitis: PF-07038124 0.03% OintmentChange From Baseline in Psoriasis Area and Severity Index (PASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 8-4.73 Units on a scaleStandard Deviation 3.383
Atopic Dermatitis: PF-07038124 0.03% OintmentChange From Baseline in Psoriasis Area and Severity Index (PASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 10-4.87 Units on a scaleStandard Deviation 3.369
Atopic Dermatitis: PF-07038124 0.03% OintmentChange From Baseline in Psoriasis Area and Severity Index (PASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 12-4.84 Units on a scaleStandard Deviation 3.53
Psoriasis: PF-07038124 0.06% OintmentChange From Baseline in Psoriasis Area and Severity Index (PASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 4-4.77 Units on a scaleStandard Deviation 3.694
Psoriasis: PF-07038124 0.06% OintmentChange From Baseline in Psoriasis Area and Severity Index (PASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 12-6.07 Units on a scaleStandard Deviation 4.058
Psoriasis: PF-07038124 0.06% OintmentChange From Baseline in Psoriasis Area and Severity Index (PASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 10-5.74 Units on a scaleStandard Deviation 3.973
Psoriasis: PF-07038124 0.06% OintmentChange From Baseline in Psoriasis Area and Severity Index (PASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 2-3.84 Units on a scaleStandard Deviation 3.357
Psoriasis: PF-07038124 0.06% OintmentChange From Baseline in Psoriasis Area and Severity Index (PASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 1-2.66 Units on a scaleStandard Deviation 2.064
Psoriasis: PF-07038124 0.06% OintmentChange From Baseline in Psoriasis Area and Severity Index (PASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 8-6.51 Units on a scaleStandard Deviation 4.002
Psoriasis: PF-07038124 0.06% OintmentChange From Baseline in Psoriasis Area and Severity Index (PASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 6-5.39 Units on a scaleStandard Deviation 3.797
Secondary

Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis

The investigator or designee assessed tolerability at the site of study intervention application, immediately post-application of the study intervention. Skin Tolerability Grading System for non-lesional skin included grade 0 (No evidence of local intolerance), grade 1 (Mild-Minimal erythema and/or edema, slight glazed appearance), grade 2 (Moderate-Definite erythema and/or edema with peeling and/or cracking but needs no adaptation of posology), grade 3 (Severe-Erythema, edema glazing with fissures, few vesicles or papules: consider removing topical agent \[if still in place\], grade 4 (very severe- Strong reaction spreading beyond the treated area, bullous reaction, erosions: removal of topical agent \[if still in place\].

Time frame: From start of study treatment (Day 1) up to Week 12

Population: Safety analysis set included all participants randomly assigned to study intervention who received at least 1 dose of study intervention.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Atopic Dermatitis: Vehicle OintmentNumber of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque PsoriasisMissing0 Participants
Atopic Dermatitis: Vehicle OintmentNumber of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque PsoriasisGrade 1 (Mild)0 Participants
Atopic Dermatitis: Vehicle OintmentNumber of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque PsoriasisGrade 3 (Severe)0 Participants
Atopic Dermatitis: Vehicle OintmentNumber of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque PsoriasisGrade 0 (None)44 Participants
Atopic Dermatitis: Vehicle OintmentNumber of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque PsoriasisGrade 2 (Moderate)0 Participants
Atopic Dermatitis: Vehicle OintmentNumber of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque PsoriasisGrade 4 (Very severe)0 Participants
Atopic Dermatitis: PF-07038124 0.01% OintmentNumber of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque PsoriasisGrade 0 (None)42 Participants
Atopic Dermatitis: PF-07038124 0.01% OintmentNumber of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque PsoriasisGrade 3 (Severe)0 Participants
Atopic Dermatitis: PF-07038124 0.01% OintmentNumber of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque PsoriasisMissing0 Participants
Atopic Dermatitis: PF-07038124 0.01% OintmentNumber of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque PsoriasisGrade 1 (Mild)0 Participants
Atopic Dermatitis: PF-07038124 0.01% OintmentNumber of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque PsoriasisGrade 4 (Very severe)0 Participants
Atopic Dermatitis: PF-07038124 0.01% OintmentNumber of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque PsoriasisGrade 2 (Moderate)0 Participants
Atopic Dermatitis: PF-07038124 0.03% OintmentNumber of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque PsoriasisGrade 4 (Very severe)0 Participants
Atopic Dermatitis: PF-07038124 0.03% OintmentNumber of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque PsoriasisGrade 2 (Moderate)0 Participants
Atopic Dermatitis: PF-07038124 0.03% OintmentNumber of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque PsoriasisMissing0 Participants
Atopic Dermatitis: PF-07038124 0.03% OintmentNumber of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque PsoriasisGrade 3 (Severe)0 Participants
Atopic Dermatitis: PF-07038124 0.03% OintmentNumber of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque PsoriasisGrade 0 (None)42 Participants
Atopic Dermatitis: PF-07038124 0.03% OintmentNumber of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque PsoriasisGrade 1 (Mild)0 Participants
Psoriasis: PF-07038124 0.06% OintmentNumber of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque PsoriasisGrade 4 (Very severe)0 Participants
Psoriasis: PF-07038124 0.06% OintmentNumber of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque PsoriasisGrade 0 (None)32 Participants
Psoriasis: PF-07038124 0.06% OintmentNumber of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque PsoriasisGrade 1 (Mild)1 Participants
Psoriasis: PF-07038124 0.06% OintmentNumber of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque PsoriasisGrade 2 (Moderate)0 Participants
Psoriasis: PF-07038124 0.06% OintmentNumber of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque PsoriasisGrade 3 (Severe)0 Participants
Psoriasis: PF-07038124 0.06% OintmentNumber of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque PsoriasisMissing1 Participants
Psoriasis: PF-07038124 0.01% OintmentNumber of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque PsoriasisGrade 3 (Severe)0 Participants
Psoriasis: PF-07038124 0.01% OintmentNumber of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque PsoriasisGrade 1 (Mild)1 Participants
Psoriasis: PF-07038124 0.01% OintmentNumber of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque PsoriasisGrade 4 (Very severe)0 Participants
Psoriasis: PF-07038124 0.01% OintmentNumber of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque PsoriasisMissing0 Participants
Psoriasis: PF-07038124 0.01% OintmentNumber of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque PsoriasisGrade 2 (Moderate)0 Participants
Psoriasis: PF-07038124 0.01% OintmentNumber of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque PsoriasisGrade 0 (None)32 Participants
Psoriasis: PF-07038124 0.03% OintmentNumber of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque PsoriasisGrade 2 (Moderate)0 Participants
Psoriasis: PF-07038124 0.03% OintmentNumber of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque PsoriasisGrade 3 (Severe)0 Participants
Psoriasis: PF-07038124 0.03% OintmentNumber of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque PsoriasisGrade 1 (Mild)1 Participants
Psoriasis: PF-07038124 0.03% OintmentNumber of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque PsoriasisGrade 4 (Very severe)0 Participants
Psoriasis: PF-07038124 0.03% OintmentNumber of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque PsoriasisGrade 0 (None)34 Participants
Psoriasis: PF-07038124 0.03% OintmentNumber of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque PsoriasisMissing0 Participants
Psoriasis: PF-07038124 0.06% OintmentNumber of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque PsoriasisGrade 2 (Moderate)0 Participants
Psoriasis: PF-07038124 0.06% OintmentNumber of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque PsoriasisGrade 1 (Mild)0 Participants
Psoriasis: PF-07038124 0.06% OintmentNumber of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque PsoriasisMissing0 Participants
Psoriasis: PF-07038124 0.06% OintmentNumber of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque PsoriasisGrade 3 (Severe)0 Participants
Psoriasis: PF-07038124 0.06% OintmentNumber of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque PsoriasisGrade 4 (Very severe)0 Participants
Psoriasis: PF-07038124 0.06% OintmentNumber of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque PsoriasisGrade 0 (None)33 Participants
Secondary

Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG): Participants With Atopic Dermatitis and Plaque Psoriasis

A standard 12-lead ECG utilizing limb leads was collected using ECG machine that automatically calculated the heart rate and measured pulse rate, QT, and QTc intervals and QRS complex. Clinically significant findings (including, but not limited to, changes from baseline in QTcF after enrollment) were determined by the investigator or qualified designee.

Time frame: From start of study treatment (Day 1) up to Week 12

Population: Safety analysis set included all participants randomly assigned to study intervention who received at least 1 dose of study intervention.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Atopic Dermatitis: Vehicle OintmentNumber of Participants With Clinically Significant Changes in Electrocardiogram (ECG): Participants With Atopic Dermatitis and Plaque Psoriasis0 Participants
Atopic Dermatitis: PF-07038124 0.01% OintmentNumber of Participants With Clinically Significant Changes in Electrocardiogram (ECG): Participants With Atopic Dermatitis and Plaque Psoriasis0 Participants
Atopic Dermatitis: PF-07038124 0.03% OintmentNumber of Participants With Clinically Significant Changes in Electrocardiogram (ECG): Participants With Atopic Dermatitis and Plaque Psoriasis0 Participants
Psoriasis: PF-07038124 0.06% OintmentNumber of Participants With Clinically Significant Changes in Electrocardiogram (ECG): Participants With Atopic Dermatitis and Plaque Psoriasis0 Participants
Psoriasis: PF-07038124 0.01% OintmentNumber of Participants With Clinically Significant Changes in Electrocardiogram (ECG): Participants With Atopic Dermatitis and Plaque Psoriasis0 Participants
Psoriasis: PF-07038124 0.03% OintmentNumber of Participants With Clinically Significant Changes in Electrocardiogram (ECG): Participants With Atopic Dermatitis and Plaque Psoriasis0 Participants
Psoriasis: PF-07038124 0.06% OintmentNumber of Participants With Clinically Significant Changes in Electrocardiogram (ECG): Participants With Atopic Dermatitis and Plaque Psoriasis0 Participants
Secondary

Number of Participants With Clinically Significant Changes in Vital Signs: Participants With Atopic Dermatitis and Plaque Psoriasis

Temperature, pulse rate, and blood pressure were assessed in vital sign examination. Body temperature was collected using oral, tympanic, axillary or temporal methods. Blood pressure and pulse rate measurements were assessed with the participant in a supine or seated position using a completely automated device after at least 5 minutes of rest for the participant. Clinically significant changes were determined by the investigator.

Time frame: From start of study treatment (Day 1) up to Week 12

Population: Safety analysis set included all participants randomly assigned to study intervention who received at least 1 dose of study intervention.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Atopic Dermatitis: Vehicle OintmentNumber of Participants With Clinically Significant Changes in Vital Signs: Participants With Atopic Dermatitis and Plaque Psoriasis0 Participants
Atopic Dermatitis: PF-07038124 0.01% OintmentNumber of Participants With Clinically Significant Changes in Vital Signs: Participants With Atopic Dermatitis and Plaque Psoriasis0 Participants
Atopic Dermatitis: PF-07038124 0.03% OintmentNumber of Participants With Clinically Significant Changes in Vital Signs: Participants With Atopic Dermatitis and Plaque Psoriasis0 Participants
Psoriasis: PF-07038124 0.06% OintmentNumber of Participants With Clinically Significant Changes in Vital Signs: Participants With Atopic Dermatitis and Plaque Psoriasis0 Participants
Psoriasis: PF-07038124 0.01% OintmentNumber of Participants With Clinically Significant Changes in Vital Signs: Participants With Atopic Dermatitis and Plaque Psoriasis0 Participants
Psoriasis: PF-07038124 0.03% OintmentNumber of Participants With Clinically Significant Changes in Vital Signs: Participants With Atopic Dermatitis and Plaque Psoriasis0 Participants
Psoriasis: PF-07038124 0.06% OintmentNumber of Participants With Clinically Significant Changes in Vital Signs: Participants With Atopic Dermatitis and Plaque Psoriasis0 Participants
Secondary

Number of Participants With Laboratory Abnormalities: Participants With Atopic Dermatitis and Plaque Psoriasis

Laboratory assessments included hematology, clinical chemistry and urinalysis. Clinically significant abnormal laboratory findings were those which were not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.

Time frame: From start of study treatment (Day 1) up to Week 12

Population: Safety analysis set included all participants randomly assigned to study intervention who received at least 1 dose of study intervention.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Atopic Dermatitis: Vehicle OintmentNumber of Participants With Laboratory Abnormalities: Participants With Atopic Dermatitis and Plaque Psoriasis18 Participants
Atopic Dermatitis: PF-07038124 0.01% OintmentNumber of Participants With Laboratory Abnormalities: Participants With Atopic Dermatitis and Plaque Psoriasis27 Participants
Atopic Dermatitis: PF-07038124 0.03% OintmentNumber of Participants With Laboratory Abnormalities: Participants With Atopic Dermatitis and Plaque Psoriasis18 Participants
Psoriasis: PF-07038124 0.06% OintmentNumber of Participants With Laboratory Abnormalities: Participants With Atopic Dermatitis and Plaque Psoriasis14 Participants
Psoriasis: PF-07038124 0.01% OintmentNumber of Participants With Laboratory Abnormalities: Participants With Atopic Dermatitis and Plaque Psoriasis14 Participants
Psoriasis: PF-07038124 0.03% OintmentNumber of Participants With Laboratory Abnormalities: Participants With Atopic Dermatitis and Plaque Psoriasis13 Participants
Psoriasis: PF-07038124 0.06% OintmentNumber of Participants With Laboratory Abnormalities: Participants With Atopic Dermatitis and Plaque Psoriasis15 Participants
Secondary

Number of Participants With Serious Adverse Events (SAEs): Participants With Atopic Dermatitis and Plaque Psoriasis

An SAE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or other important medical events.

Time frame: From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)

Population: Safety analysis set included all participants randomly assigned to study intervention who received at least 1 dose of study intervention.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Atopic Dermatitis: Vehicle OintmentNumber of Participants With Serious Adverse Events (SAEs): Participants With Atopic Dermatitis and Plaque Psoriasis0 Participants
Atopic Dermatitis: PF-07038124 0.01% OintmentNumber of Participants With Serious Adverse Events (SAEs): Participants With Atopic Dermatitis and Plaque Psoriasis1 Participants
Atopic Dermatitis: PF-07038124 0.03% OintmentNumber of Participants With Serious Adverse Events (SAEs): Participants With Atopic Dermatitis and Plaque Psoriasis1 Participants
Psoriasis: PF-07038124 0.06% OintmentNumber of Participants With Serious Adverse Events (SAEs): Participants With Atopic Dermatitis and Plaque Psoriasis0 Participants
Psoriasis: PF-07038124 0.01% OintmentNumber of Participants With Serious Adverse Events (SAEs): Participants With Atopic Dermatitis and Plaque Psoriasis0 Participants
Psoriasis: PF-07038124 0.03% OintmentNumber of Participants With Serious Adverse Events (SAEs): Participants With Atopic Dermatitis and Plaque Psoriasis0 Participants
Psoriasis: PF-07038124 0.06% OintmentNumber of Participants With Serious Adverse Events (SAEs): Participants With Atopic Dermatitis and Plaque Psoriasis1 Participants
Secondary

Number of Participants With Treatment Emergent Adverse Events (AEs): Participants With Atopic Dermatitis and Plaque Psoriasis

An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered TEAE if the event occurred on or after the first dosing date but before the last dose plus the lag time (35 days).

Time frame: From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)

Population: Safety analysis set included all participants randomly assigned to study intervention who received at least 1 dose of study intervention.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Atopic Dermatitis: Vehicle OintmentNumber of Participants With Treatment Emergent Adverse Events (AEs): Participants With Atopic Dermatitis and Plaque Psoriasis20 Participants
Atopic Dermatitis: PF-07038124 0.01% OintmentNumber of Participants With Treatment Emergent Adverse Events (AEs): Participants With Atopic Dermatitis and Plaque Psoriasis28 Participants
Atopic Dermatitis: PF-07038124 0.03% OintmentNumber of Participants With Treatment Emergent Adverse Events (AEs): Participants With Atopic Dermatitis and Plaque Psoriasis19 Participants
Psoriasis: PF-07038124 0.06% OintmentNumber of Participants With Treatment Emergent Adverse Events (AEs): Participants With Atopic Dermatitis and Plaque Psoriasis9 Participants
Psoriasis: PF-07038124 0.01% OintmentNumber of Participants With Treatment Emergent Adverse Events (AEs): Participants With Atopic Dermatitis and Plaque Psoriasis13 Participants
Psoriasis: PF-07038124 0.03% OintmentNumber of Participants With Treatment Emergent Adverse Events (AEs): Participants With Atopic Dermatitis and Plaque Psoriasis11 Participants
Psoriasis: PF-07038124 0.06% OintmentNumber of Participants With Treatment Emergent Adverse Events (AEs): Participants With Atopic Dermatitis and Plaque Psoriasis19 Participants
Secondary

Percentage of Adult (18-75 Years Old) Participants With >=4 Points of Reduction From Baseline in Weekly Average of PP-NRS at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis Only

The PP-NRS was a daily participant 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. Participants were asked to assess their itch intensity over the past 24 hours, on a scale from 0 (no itching) to 10 (worst possible itching). Higher scores indicated worse itch. For the PP-NRS score, baseline was defined as the average of all values recorded between Day -7 (7 days prior to dosing) and Day -1 (1 day prior to dosing). In this OM, percentages of plaque psoriasis participants (18-75 years old) with \>=4 points of reduction in weekly averages of PP-NRS from baseline are reported (percentage based on number of participants with baseline \>=4).

Time frame: Week 1, 2, 4, 6, 8, 10 and 12

Population: ITT analysis set included all participants randomly assigned to study intervention.Here,'Overall Number of Participants Analyzed'=participants evaluable for this OM,all participants reported under'Overall Number of Participants Analyzed'contributed data to table but may not have evaluable data for every row.Here,'Number Analyzed'=participants evaluable for specified rows.For this OM,data collection was not planned for 3 arms:AD Vehicle QD, PF-07038124 0.01% QD,AD PF-07038124 0.03% QD ointment.

ArmMeasureGroupValue (NUMBER)
Atopic Dermatitis: Vehicle OintmentPercentage of Adult (18-75 Years Old) Participants With >=4 Points of Reduction From Baseline in Weekly Average of PP-NRS at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 1017.4 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Adult (18-75 Years Old) Participants With >=4 Points of Reduction From Baseline in Weekly Average of PP-NRS at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 1217.4 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Adult (18-75 Years Old) Participants With >=4 Points of Reduction From Baseline in Weekly Average of PP-NRS at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 48.7 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Adult (18-75 Years Old) Participants With >=4 Points of Reduction From Baseline in Weekly Average of PP-NRS at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 24.3 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Adult (18-75 Years Old) Participants With >=4 Points of Reduction From Baseline in Weekly Average of PP-NRS at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 14.3 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Adult (18-75 Years Old) Participants With >=4 Points of Reduction From Baseline in Weekly Average of PP-NRS at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 817.4 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Adult (18-75 Years Old) Participants With >=4 Points of Reduction From Baseline in Weekly Average of PP-NRS at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 64.3 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Adult (18-75 Years Old) Participants With >=4 Points of Reduction From Baseline in Weekly Average of PP-NRS at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 10 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Adult (18-75 Years Old) Participants With >=4 Points of Reduction From Baseline in Weekly Average of PP-NRS at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 1240.9 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Adult (18-75 Years Old) Participants With >=4 Points of Reduction From Baseline in Weekly Average of PP-NRS at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 840.9 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Adult (18-75 Years Old) Participants With >=4 Points of Reduction From Baseline in Weekly Average of PP-NRS at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 213.6 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Adult (18-75 Years Old) Participants With >=4 Points of Reduction From Baseline in Weekly Average of PP-NRS at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 631.8 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Adult (18-75 Years Old) Participants With >=4 Points of Reduction From Baseline in Weekly Average of PP-NRS at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 422.7 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Adult (18-75 Years Old) Participants With >=4 Points of Reduction From Baseline in Weekly Average of PP-NRS at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 1036.4 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Adult (18-75 Years Old) Participants With >=4 Points of Reduction From Baseline in Weekly Average of PP-NRS at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 1233.3 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Adult (18-75 Years Old) Participants With >=4 Points of Reduction From Baseline in Weekly Average of PP-NRS at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 112.5 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Adult (18-75 Years Old) Participants With >=4 Points of Reduction From Baseline in Weekly Average of PP-NRS at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 220.8 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Adult (18-75 Years Old) Participants With >=4 Points of Reduction From Baseline in Weekly Average of PP-NRS at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 425.0 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Adult (18-75 Years Old) Participants With >=4 Points of Reduction From Baseline in Weekly Average of PP-NRS at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 625.0 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Adult (18-75 Years Old) Participants With >=4 Points of Reduction From Baseline in Weekly Average of PP-NRS at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 825.0 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Adult (18-75 Years Old) Participants With >=4 Points of Reduction From Baseline in Weekly Average of PP-NRS at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 1029.2 Percentage of participants
Psoriasis: PF-07038124 0.06% OintmentPercentage of Adult (18-75 Years Old) Participants With >=4 Points of Reduction From Baseline in Weekly Average of PP-NRS at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 642.1 Percentage of participants
Psoriasis: PF-07038124 0.06% OintmentPercentage of Adult (18-75 Years Old) Participants With >=4 Points of Reduction From Baseline in Weekly Average of PP-NRS at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 426.3 Percentage of participants
Psoriasis: PF-07038124 0.06% OintmentPercentage of Adult (18-75 Years Old) Participants With >=4 Points of Reduction From Baseline in Weekly Average of PP-NRS at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 1247.4 Percentage of participants
Psoriasis: PF-07038124 0.06% OintmentPercentage of Adult (18-75 Years Old) Participants With >=4 Points of Reduction From Baseline in Weekly Average of PP-NRS at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 1047.4 Percentage of participants
Psoriasis: PF-07038124 0.06% OintmentPercentage of Adult (18-75 Years Old) Participants With >=4 Points of Reduction From Baseline in Weekly Average of PP-NRS at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 221.1 Percentage of participants
Psoriasis: PF-07038124 0.06% OintmentPercentage of Adult (18-75 Years Old) Participants With >=4 Points of Reduction From Baseline in Weekly Average of PP-NRS at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 15.3 Percentage of participants
Psoriasis: PF-07038124 0.06% OintmentPercentage of Adult (18-75 Years Old) Participants With >=4 Points of Reduction From Baseline in Weekly Average of PP-NRS at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 852.6 Percentage of participants
Comparison: Week 1p-value: 0.727895% CI: [-21.9, 11.5]Chan and Zhang (1999) method
Comparison: Week 1p-value: 0.254895% CI: [-11.5, 28.2]Chan and Zhang (1999) method
Comparison: Week 1p-value: 0.516295% CI: [-17.5, 21.9]Chan and Zhang (1999) method
Comparison: Week 2p-value: 0.166395% CI: [-11.4, 30.7]Chan and Zhang (1999) method
Comparison: Week 2p-value: 0.060595% CI: [-4.2, 38.3]Chan and Zhang (1999) method
Comparison: Week 2p-value: 0.059295% CI: [-5.4, 41.6]Chan and Zhang (1999) method
Comparison: Week 4p-value: 0.124695% CI: [-8.6, 37.4]Chan and Zhang (1999) method
Comparison: Week 4p-value: 0.078995% CI: [-7.3, 39.7]Chan and Zhang (1999) method
Comparison: Week 4p-value: 0.088995% CI: [-6.4, 43.7]Chan and Zhang (1999) method
Comparison: Week 6p-value: 0.009795% CI: [4.2, 50.7]Chan and Zhang (1999) method
Comparison: Week 6p-value: 0.029495% CI: [-0.8, 43.6]Chan and Zhang (1999) method
Comparison: Week 6p-value: 0.001895% CI: [10.9, 62.2]Chan and Zhang (1999) method
Comparison: Week 8p-value: 0.049595% CI: [-3.8, 48.9]Chan and Zhang (1999) method
Comparison: Week 8p-value: 0.28995% CI: [-17.3, 32.4]Chan and Zhang (1999) method
Comparison: Week 8p-value: 0.010395% CI: [5.1, 62]Chan and Zhang (1999) method
Comparison: Week 10p-value: 0.108895% CI: [-7.8, 44.8]Chan and Zhang (1999) method
Comparison: Week 10p-value: 0.271995% CI: [-14, 36.2]Chan and Zhang (1999) method
Comparison: Week 10p-value: 0.022795% CI: [0.4, 56.6]Chan and Zhang (1999) method
Comparison: Week 12p-value: 0.049595% CI: [-3.8, 48.9]Chan and Zhang (1999) method
Comparison: Week 12p-value: 0.124695% CI: [-10.6, 40.6]Chan and Zhang (1999) method
Comparison: Week 12p-value: 0.022795% CI: [0.4, 56.6]Chan and Zhang (1999) method
Secondary

Percentage of Participants With >= 4 Points of Reduction From Baseline in Weekly Average of Peak Pruritus Numerical Rating Scale (PP-NRS) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis Only

The PP-NRS was a daily participant 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. Participants were asked to assess their itch intensity over the past 24 hours, on a scale from 0 (no itching) to 10 (worst possible itching). Higher scores indicated worse itch. For the PP-NRS score, baseline was defined as the average of all values recorded between Day -7 (7 days prior to dosing) and Day -1 (1 day prior to dosing). In this OM, percentages of AD participants with \>=4 points of reduction in weekly averages of PP-NRS from baseline are reported (percentage based on number of participants with baseline \>=4).

Time frame: Baseline, Week 1, 2, 4, 6, 8, 10 and 12

Population: ITT analysis set included all participants randomly assigned to study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. For this outcome measure (OM), data collection was not planned for the 4 arms of Psoriasis Vehicle QD, Psoriasis PF-07038124 0.01% QD, Psoriasis PF-07038124 0.03% and Psoriasis PF-07038124 0.06% ointment.

ArmMeasureGroupValue (NUMBER)
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With >= 4 Points of Reduction From Baseline in Weekly Average of Peak Pruritus Numerical Rating Scale (PP-NRS) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 410.0 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With >= 4 Points of Reduction From Baseline in Weekly Average of Peak Pruritus Numerical Rating Scale (PP-NRS) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 1215.0 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With >= 4 Points of Reduction From Baseline in Weekly Average of Peak Pruritus Numerical Rating Scale (PP-NRS) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 817.5 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With >= 4 Points of Reduction From Baseline in Weekly Average of Peak Pruritus Numerical Rating Scale (PP-NRS) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 617.5 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With >= 4 Points of Reduction From Baseline in Weekly Average of Peak Pruritus Numerical Rating Scale (PP-NRS) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 20 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With >= 4 Points of Reduction From Baseline in Weekly Average of Peak Pruritus Numerical Rating Scale (PP-NRS) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 12.5 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With >= 4 Points of Reduction From Baseline in Weekly Average of Peak Pruritus Numerical Rating Scale (PP-NRS) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 1017.5 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With >= 4 Points of Reduction From Baseline in Weekly Average of Peak Pruritus Numerical Rating Scale (PP-NRS) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 821.1 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With >= 4 Points of Reduction From Baseline in Weekly Average of Peak Pruritus Numerical Rating Scale (PP-NRS) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 15.3 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With >= 4 Points of Reduction From Baseline in Weekly Average of Peak Pruritus Numerical Rating Scale (PP-NRS) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 218.4 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With >= 4 Points of Reduction From Baseline in Weekly Average of Peak Pruritus Numerical Rating Scale (PP-NRS) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 423.7 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With >= 4 Points of Reduction From Baseline in Weekly Average of Peak Pruritus Numerical Rating Scale (PP-NRS) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 621.1 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With >= 4 Points of Reduction From Baseline in Weekly Average of Peak Pruritus Numerical Rating Scale (PP-NRS) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 1023.7 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With >= 4 Points of Reduction From Baseline in Weekly Average of Peak Pruritus Numerical Rating Scale (PP-NRS) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 1226.3 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With >= 4 Points of Reduction From Baseline in Weekly Average of Peak Pruritus Numerical Rating Scale (PP-NRS) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 829.4 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With >= 4 Points of Reduction From Baseline in Weekly Average of Peak Pruritus Numerical Rating Scale (PP-NRS) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 214.7 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With >= 4 Points of Reduction From Baseline in Weekly Average of Peak Pruritus Numerical Rating Scale (PP-NRS) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 1235.3 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With >= 4 Points of Reduction From Baseline in Weekly Average of Peak Pruritus Numerical Rating Scale (PP-NRS) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 1026.5 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With >= 4 Points of Reduction From Baseline in Weekly Average of Peak Pruritus Numerical Rating Scale (PP-NRS) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 10 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With >= 4 Points of Reduction From Baseline in Weekly Average of Peak Pruritus Numerical Rating Scale (PP-NRS) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 626.5 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With >= 4 Points of Reduction From Baseline in Weekly Average of Peak Pruritus Numerical Rating Scale (PP-NRS) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 429.4 Percentage of participants
Comparison: Week 1p-value: 0.325595% CI: [-8.5, 15.8]Chan and Zhang (1999) method
Comparison: Week 1p-value: 0.718195% CI: [-13.3, 8.3]Chan and Zhang (1999) method
Comparison: Week 2p-value: 0.002295% CI: [7, 34.3]Chan and Zhang (1999) method
Comparison: Week 2p-value: 0.006495% CI: [3.7, 31.1]Chan and Zhang (1999) method
Comparison: Week 4p-value: 0.065995% CI: [-3.4, 31.5]Chan and Zhang (1999) method
Comparison: Week 4p-value: 0.018995% CI: [0.9, 38.5]Chan and Zhang (1999) method
Comparison: Week 6p-value: 0.396295% CI: [-14.9, 22.3]Chan and Zhang (1999) method
Comparison: Week 6p-value: 0.233395% CI: [-10.4, 29.1]Chan and Zhang (1999) method
Comparison: Week 8p-value: 0.396295% CI: [-14.9, 22.3]Chan and Zhang (1999) method
Comparison: Week 8p-value: 0.135395% CI: [-7.9, 32.7]Chan and Zhang (1999) method
Comparison: Week 10p-value: 0.279195% CI: [-12.8, 25.7]Chan and Zhang (1999) method
Comparison: Week 10p-value: 0.233395% CI: [-10.4, 29.1]Chan and Zhang (1999) method
Comparison: Week 12p-value: 0.129595% CI: [-7.3, 30.6]Chan and Zhang (1999) method
Comparison: Week 12p-value: 0.024795% CI: [0.1, 40.2]Chan and Zhang (1999) method
Secondary

Percentage of Participants With >= 75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Atopic Dermatitis Only

EASI quantified severity of AD based on severity of lesion clinical signs and % of body surface area(BSA)affected.Severity of clinical signs of AD lesions (erythema \[E\], induration/papulation\[I\],excoriation\[Ex\] and lichenification\[L\]) were scored separately for each of 4 body regions(head and neck, upper limbs, trunk \[including axillae and groin)\], lower limbs \[including buttocks\]) on a 4-point scale:0= absent; 1= mild;2= moderate;3= severe.EASI area score was based on % 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;h= head and neck;u= upper limbs;t= trunk;l= lower limbs.Total EASI score=0.0 to 72.0, higher scores indicate greater severity of AD.EASI 75 response was defined as at least a 75% reduction in EASI relative to Baseline.95% CI was based on Blyth-Still-Casella method.

Time frame: Baseline, Week 1, 2, 4, 6, 8, 10 and 12

Population: ITT analysis set included all participants randomly assigned to study intervention. For this OM, data collection was not planned for the 4 arms of Psoriasis Vehicle QD, Psoriasis PF-07038124 0.01% QD, Psoriasis PF-07038124 0.03% and Psoriasis PF-07038124 0.06% ointment.

ArmMeasureGroupValue (NUMBER)
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With >= 75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Atopic Dermatitis OnlyWeek 22.3 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With >= 75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Atopic Dermatitis OnlyWeek 815.9 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With >= 75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Atopic Dermatitis OnlyWeek 613.6 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With >= 75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Atopic Dermatitis OnlyWeek 12.3 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With >= 75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Atopic Dermatitis OnlyWeek 1213.6 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With >= 75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Atopic Dermatitis OnlyWeek 1013.6 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With >= 75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Atopic Dermatitis OnlyWeek 411.4 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With >= 75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Atopic Dermatitis OnlyWeek 621.4 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With >= 75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Atopic Dermatitis OnlyWeek 12.4 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With >= 75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Atopic Dermatitis OnlyWeek 211.9 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With >= 75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Atopic Dermatitis OnlyWeek 411.9 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With >= 75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Atopic Dermatitis OnlyWeek 819.0 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With >= 75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Atopic Dermatitis OnlyWeek 1021.4 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With >= 75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Atopic Dermatitis OnlyWeek 1226.2 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With >= 75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Atopic Dermatitis OnlyWeek 814.3 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With >= 75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Atopic Dermatitis OnlyWeek 27.1 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With >= 75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Atopic Dermatitis OnlyWeek 1228.6 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With >= 75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Atopic Dermatitis OnlyWeek 1019.0 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With >= 75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Atopic Dermatitis OnlyWeek 616.7 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With >= 75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Atopic Dermatitis OnlyWeek 416.7 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With >= 75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Atopic Dermatitis OnlyWeek 14.8 Percentage of participants
Comparison: Week 1p-value: 0.570195% CI: [-10.2, 10.7]Chan and Zhang (1999) method
Comparison: Week 1p-value: 0.326995% CI: [-8.4, 14.1]Chan and Zhang (1999) method
Comparison: Week 2p-value: 0.053295% CI: [-2, 23.7]Chan and Zhang (1999) method
Comparison: Week 2p-value: 0.170595% CI: [-6.1, 17.6]Chan and Zhang (1999) method
Comparison: Week 4p-value: 0.512395% CI: [-14.4, 15.7]Chan and Zhang (1999) method
Comparison: Week 4p-value: 0.275195% CI: [-10.7, 22.1]Chan and Zhang (1999) method
Comparison: Week 6p-value: 0.273695% CI: [-8.9, 24.8]Chan and Zhang (1999) method
Comparison: Week 6p-value: 0.396795% CI: [-13, 19.8]Chan and Zhang (1999) method
Comparison: Week 8p-value: 0.399795% CI: [-13.6, 20.2]Chan and Zhang (1999) method
Comparison: Week 8p-value: 0.546195% CI: [-17.7, 15.3]Chan and Zhang (1999) method
Comparison: Week 10p-value: 0.273695% CI: [-8.9, 24.8]Chan and Zhang (1999) method
Comparison: Week 10p-value: 0.275495% CI: [-11, 22.1]Chan and Zhang (1999) method
Comparison: Week 12p-value: 0.097795% CI: [-4.8, 30.3]Chan and Zhang (1999) method
Comparison: Week 12p-value: 0.054295% CI: [-2.8, 33.2]Chan and Zhang (1999) method
Secondary

Percentage of Participants With >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Plaque Psoriasis Only

The PASI quantified the severity of a participant'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 score =0.1Ah(Eh+Ih+Sh) + 0.2Au(Eu+Iu+Su) + 0.3At(Et+It+St) + 0.4Al(El+Il+Sl) (A= PASI area score,S=scaling)PASI 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline. 95% confidence interval was based on Blyth-Still-Casella method.

Time frame: Baseline, Week 1, 2, 4, 6, 8, 10 and 12

Population: ITT analysis set included all participants randomly assigned to study intervention. For this OM, data collection was not planned for the 3 arms of AD Vehicle QD, AD PF-07038124 0.01% QD and AD PF-07038124 0.03% QD.

ArmMeasureGroupValue (NUMBER)
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Plaque Psoriasis OnlyWeek 10 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Plaque Psoriasis OnlyWeek 108.8 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Plaque Psoriasis OnlyWeek 82.9 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Plaque Psoriasis OnlyWeek 20 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Plaque Psoriasis OnlyWeek 1214.7 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Plaque Psoriasis OnlyWeek 40 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Plaque Psoriasis OnlyWeek 60 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Plaque Psoriasis OnlyWeek 1030.3 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Plaque Psoriasis OnlyWeek 621.2 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Plaque Psoriasis OnlyWeek 415.2 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Plaque Psoriasis OnlyWeek 818.2 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Plaque Psoriasis OnlyWeek 1227.3 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Plaque Psoriasis OnlyWeek 29.1 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Plaque Psoriasis OnlyWeek 13.0 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Plaque Psoriasis OnlyWeek 622.9 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Plaque Psoriasis OnlyWeek 10 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Plaque Psoriasis OnlyWeek 22.9 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Plaque Psoriasis OnlyWeek 414.3 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Plaque Psoriasis OnlyWeek 825.7 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Plaque Psoriasis OnlyWeek 1028.6 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Plaque Psoriasis OnlyWeek 1225.7 Percentage of participants
Psoriasis: PF-07038124 0.06% OintmentPercentage of Participants With >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Plaque Psoriasis OnlyWeek 421.2 Percentage of participants
Psoriasis: PF-07038124 0.06% OintmentPercentage of Participants With >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Plaque Psoriasis OnlyWeek 1251.5 Percentage of participants
Psoriasis: PF-07038124 0.06% OintmentPercentage of Participants With >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Plaque Psoriasis OnlyWeek 1048.5 Percentage of participants
Psoriasis: PF-07038124 0.06% OintmentPercentage of Participants With >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Plaque Psoriasis OnlyWeek 215.2 Percentage of participants
Psoriasis: PF-07038124 0.06% OintmentPercentage of Participants With >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Plaque Psoriasis OnlyWeek 19.1 Percentage of participants
Psoriasis: PF-07038124 0.06% OintmentPercentage of Participants With >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Plaque Psoriasis OnlyWeek 833.3 Percentage of participants
Psoriasis: PF-07038124 0.06% OintmentPercentage of Participants With >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Plaque Psoriasis OnlyWeek 633.3 Percentage of participants
Comparison: Week 4p-value: 0.010495% CI: [3.2, 32]Chan and Zhang (1999) method
Comparison: Week 1p-value: 0.257895% CI: [-7.8, 15.8]Chan and Zhang (1999) method
Comparison: Week 1p-value: 195% CI: [-10.6, 10.1]Chan and Zhang (1999) method
Comparison: Week 1p-value: 0.043695% CI: [-2.1, 24.3]Chan and Zhang (1999) method
Comparison: Week 2p-value: 0.043695% CI: [-2.1, 24.3]Chan and Zhang (1999) method
Comparison: Week 2p-value: 0.269795% CI: [-7.8, 14.9]Chan and Zhang (1999) method
Comparison: Week 2p-value: 0.010495% CI: [3.2, 32]Chan and Zhang (1999) method
Comparison: Week 4p-value: 0.012995% CI: [2.6, 30.3]Chan and Zhang (1999) method
Comparison: Week 4p-value: 0.002495% CI: [8, 38.9]Chan and Zhang (1999) method
Comparison: Week 6p-value: 0.002495% CI: [8, 38.9]Chan and Zhang (1999) method
Comparison: Week 6p-value: 0.001895% CI: [9.5, 40.1]Chan and Zhang (1999) method
Comparison: Week 6p-value: 0.000195% CI: [17.8, 51.8]Chan and Zhang (1999) method
Comparison: Week 8p-value: 0.025995% CI: [-0.1, 32.5]Chan and Zhang (1999) method
Comparison: Week 8p-value: 0.003895% CI: [6.3, 40.4]Chan and Zhang (1999) method
Comparison: Week 8p-value: 0.000795% CI: [12.2, 48.9]Chan and Zhang (1999) method
Comparison: Week 10p-value: 0.014695% CI: [2.1, 41.2]Chan and Zhang (1999) method
Comparison: Week 10p-value: 0.020595% CI: [1, 38.9]Chan and Zhang (1999) method
Comparison: Week 10p-value: 0.000295% CI: [17.1, 59.3]Chan and Zhang (1999) method
Comparison: Week 12p-value: 0.124595% CI: [-7.8, 32.6]Chan and Zhang (1999) method
Comparison: Week 12p-value: 0.143195% CI: [-9.1, 31.5]Chan and Zhang (1999) method
Comparison: Week 12p-value: 0.000795% CI: [12.2, 56.8]Chan and Zhang (1999) method
Secondary

Percentage of Participants With IGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >= 2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Atopic Dermatitis Only

IGA assessed severity of AD on 5-point scale ranging from 0(clear)to 4(severe)higher scores indicate more severity,reflecting a global consideration of erythema (ery),induration and scaling. Clinical evaluator assessed overall severity of AD and assigned IGA score as follows: 0 (clear) no inflammatory signs of AD; 1=almost clear, AD not fully cleared-light pink residual lesions(except post-inflammatory hyperpigmentation),just perceptible ery, papulation/induration lichenification, excoriation, no oozing/crusting; 2=mild AD with light red lesions, slight but definite ery, papulation/induration, lichenification, excoriation, no oozing/crusting; 3=moderate AD with red lesions, moderate ery, papulation/induration, lichenification, excoriation, slight oozing/crusting; 4=severe AD with deep dark red lesions, severe ery, papulation/induration, lichenification, excoriation, moderate to severe oozing/crusting.95%confidence interval was based on Blyth-Still-Casella method.

Time frame: Baseline, Week 1, 2, 4, 6, 8, and 10

Population: ITT analysis set included all participants randomly assigned to study intervention. For this outcome measure (OM), data collection was not planned for the 4 arms of Psoriasis Vehicle QD, Psoriasis PF-07038124 0.01% QD, Psoriasis PF-07038124 0.03% and Psoriasis PF-07038124 0.06% ointment.

ArmMeasureGroupValue (NUMBER)
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With IGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >= 2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Atopic Dermatitis OnlyWeek 12.3 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With IGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >= 2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Atopic Dermatitis OnlyWeek 22.3 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With IGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >= 2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Atopic Dermatitis OnlyWeek 49.1 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With IGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >= 2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Atopic Dermatitis OnlyWeek 66.8 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With IGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >= 2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Atopic Dermatitis OnlyWeek 86.8 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With IGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >= 2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Atopic Dermatitis OnlyWeek 1011.4 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With IGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >= 2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Atopic Dermatitis OnlyWeek 1019.0 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With IGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >= 2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Atopic Dermatitis OnlyWeek 14.8 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With IGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >= 2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Atopic Dermatitis OnlyWeek 614.3 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With IGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >= 2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Atopic Dermatitis OnlyWeek 816.7 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With IGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >= 2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Atopic Dermatitis OnlyWeek 27.1 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With IGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >= 2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Atopic Dermatitis OnlyWeek 414.3 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With IGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >= 2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Atopic Dermatitis OnlyWeek 29.5 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With IGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >= 2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Atopic Dermatitis OnlyWeek 411.9 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With IGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >= 2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Atopic Dermatitis OnlyWeek 1014.3 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With IGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >= 2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Atopic Dermatitis OnlyWeek 614.3 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With IGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >= 2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Atopic Dermatitis OnlyWeek 14.8 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With IGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >= 2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Atopic Dermatitis OnlyWeek 89.5 Percentage of participants
Comparison: Week 1p-value: 0.326995% CI: [-8.4, 14.1]Chan and Zhang (1999) method
Comparison: Week 1p-value: 0.326995% CI: [-8.4, 14.1]Chan and Zhang (1999) method
Comparison: Week 2p-value: 0.170595% CI: [-6.1, 17.6]Chan and Zhang (1999) method
Comparison: Week 2p-value: 0.111895% CI: [-3.9, 20.5]Chan and Zhang (1999) method
Comparison: Week 4p-value: 0.275195% CI: [-9.5, 20.5]Chan and Zhang (1999) method
Comparison: Week 4p-value: 0.385795% CI: [-11.4, 17.6]Chan and Zhang (1999) method
Comparison: Week 6p-value: 0.142995% CI: [-6.4, 22.6]Chan and Zhang (1999) method
Comparison: Week 6p-value: 0.142995% CI: [-6.4, 22.6]Chan and Zhang (1999) method
Comparison: Week 8p-value: 0.111995% CI: [-4.4, 25.3]Chan and Zhang (1999) method
Comparison: Week 8p-value: 0.375595% CI: [-10.7, 16.7]Chan and Zhang (1999) method
Comparison: Week 10p-value: 0.254795% CI: [-8.4, 24.3]Chan and Zhang (1999) method
Comparison: Week 10p-value: 0.392895% CI: [-12.7, 18.6]Chan and Zhang (1999) method
Secondary

Percentage of Participants With IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis Only

IGA assessed severity of AD on 5-point scale ranging from 0(clear)to 4(severe)higher scores indicate more severity,reflecting a global consideration of erythema (ery),induration and scaling. Clinical evaluator assessed overall severity of AD and assigned IGA score as follows: 0 (clear) no inflammatory signs of AD; 1=almost clear, AD not fully cleared-light pink residual lesions(except post-inflammatory hyperpigmentation),just perceptible ery, papulation/induration lichenification, excoriation, no oozing/crusting; 2=mild AD with light red lesions, slight but definite ery, papulation/induration, lichenification, excoriation, no oozing/crusting; 3=moderate AD with red lesions, moderate ery, papulation/induration, lichenification, excoriation, slight oozing/crusting; 4=severe AD with deep dark red lesions, severe ery, papulation/induration, lichenification, excoriation, moderate to severe oozing/crusting. 95% confidence interval was based on Blyth-Still-Casella method.

Time frame: Week 1, 2, 4, 6, 8, 10 and 12

Population: ITT analysis set included all participants randomly assigned to study intervention. For this outcome measure (OM), data collection was not planned for the 4 arms of Psoriasis Vehicle QD, Psoriasis PF-07038124 0.01% QD, Psoriasis PF-07038124 0.03% and Psoriasis PF-07038124 0.06% ointment.

ArmMeasureGroupValue (NUMBER)
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 24.5 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 811.4 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 1215.9 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 411.4 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 1015.9 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 12.3 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 69.1 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 14.8 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 1019.0 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 614.3 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 1223.8 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 27.1 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 416.7 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 816.7 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 1228.6 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 211.9 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 419.0 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 621.4 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 816.7 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 14.8 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 1019.0 Percentage of participants
Comparison: Week 1p-value: 0.326995% CI: [-8.4, 14.1]Chan and Zhang (1999) method
Comparison: Week 1p-value: 0.326995% CI: [-8.4, 14.1]Chan and Zhang (1999) method
Comparison: Week 2p-value: 0.358595% CI: [-9.2, 15.5]Chan and Zhang (1999) method
Comparison: Week 2p-value: 0.12995% CI: [-5.3, 22.1]Chan and Zhang (1999) method
Comparison: Week 4p-value: 0.275195% CI: [-10.7, 22.1]Chan and Zhang (1999) method
Comparison: Week 4p-value: 0.254795% CI: [-8.4, 24.3]Chan and Zhang (1999) method
Comparison: Week 6p-value: 0.275195% CI: [-9.5, 20.5]Chan and Zhang (1999) method
Comparison: Week 6p-value: 0.065895% CI: [-3.8, 28.8]Chan and Zhang (1999) method
Comparison: Week 8p-value: 0.275195% CI: [-10.7, 22.1]Chan and Zhang (1999) method
Comparison: Week 8p-value: 0.275195% CI: [-10.7, 22.1]Chan and Zhang (1999) method
Comparison: Week 10p-value: 0.399795% CI: [-13.6, 20.2]Chan and Zhang (1999) method
Comparison: Week 10p-value: 0.399795% CI: [-13.6, 20.2]Chan and Zhang (1999) method
Comparison: Week 12p-value: 0.273695% CI: [-9.5, 25.7]Chan and Zhang (1999) method
Comparison: Week 12p-value: 0.111995% CI: [-5.6, 31]Chan and Zhang (1999) method
Secondary

Percentage of Participants With PGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Plaque Psoriasis Only

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 OM, percentages of participants with a PGA score of 0 or 1 and an improvement of \>=2 from Baseline in PGA score were reported. 95% confidence interval was based on Blyth-Still-Casella method.

Time frame: Baseline, Week 1, 2, 4, 6, 8, and 10

Population: ITT analysis set included all participants randomly assigned to study intervention. For this OM, data collection was not planned for the 3 arms of AD Vehicle QD, AD PF-07038124 0.01% QD and AD PF-07038124 0.03% QD.

ArmMeasureGroupValue (NUMBER)
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Plaque Psoriasis OnlyWeek 10 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Plaque Psoriasis OnlyWeek 20 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Plaque Psoriasis OnlyWeek 40 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Plaque Psoriasis OnlyWeek 60 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Plaque Psoriasis OnlyWeek 80 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Plaque Psoriasis OnlyWeek 105.9 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Plaque Psoriasis OnlyWeek 1015.2 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Plaque Psoriasis OnlyWeek 615.2 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Plaque Psoriasis OnlyWeek 10 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Plaque Psoriasis OnlyWeek 46.1 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Plaque Psoriasis OnlyWeek 26.1 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Plaque Psoriasis OnlyWeek 89.1 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Plaque Psoriasis OnlyWeek 25.7 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Plaque Psoriasis OnlyWeek 417.1 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Plaque Psoriasis OnlyWeek 617.1 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Plaque Psoriasis OnlyWeek 1031.4 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Plaque Psoriasis OnlyWeek 828.6 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Plaque Psoriasis OnlyWeek 10 Percentage of participants
Psoriasis: PF-07038124 0.06% OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Plaque Psoriasis OnlyWeek 827.3 Percentage of participants
Psoriasis: PF-07038124 0.06% OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Plaque Psoriasis OnlyWeek 1039.4 Percentage of participants
Psoriasis: PF-07038124 0.06% OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Plaque Psoriasis OnlyWeek 29.1 Percentage of participants
Psoriasis: PF-07038124 0.06% OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Plaque Psoriasis OnlyWeek 624.2 Percentage of participants
Psoriasis: PF-07038124 0.06% OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Plaque Psoriasis OnlyWeek 13.0 Percentage of participants
Psoriasis: PF-07038124 0.06% OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Plaque Psoriasis OnlyWeek 415.2 Percentage of participants
Comparison: Week 1p-value: 195% CI: [-10.6, 11]Chan and Zhang (1999) method
Comparison: Week 1p-value: 195% CI: [-10.6, 10.1]Chan and Zhang (1999) method
Comparison: Week 1p-value: 0.257895% CI: [-7.8, 15.8]Chan and Zhang (1999) method
Comparison: Week 2p-value: 0.099395% CI: [-4.9, 20.7]Chan and Zhang (1999) method
Comparison: Week 2p-value: 0.11495% CI: [-5.3, 19.2]Chan and Zhang (1999) method
Comparison: Week 2p-value: 0.043695% CI: [-2.1, 24.3]Chan and Zhang (1999) method
Comparison: Week 4p-value: 0.099395% CI: [-4.9, 20.7]Chan and Zhang (1999) method
Comparison: Week 4p-value: 0.007195% CI: [4.9, 33.9]Chan and Zhang (1999) method
Comparison: Week 4p-value: 0.010495% CI: [3.2, 32]Chan and Zhang (1999) method
Comparison: Week 6p-value: 0.010495% CI: [3.2, 32]Chan and Zhang (1999) method
Comparison: Week 6p-value: 0.007195% CI: [4.9, 33.9]Chan and Zhang (1999) method
Comparison: Week 6p-value: 0.001195% CI: [10.4, 42.3]Chan and Zhang (1999) method
Comparison: Week 8p-value: 0.043695% CI: [-2.1, 24.3]Chan and Zhang (1999) method
Comparison: Week 8p-value: 0.000395% CI: [14.2, 46.3]Chan and Zhang (1999) method
Comparison: Week 8p-value: 0.000795% CI: [12.9, 45.8]Chan and Zhang (1999) method
Comparison: Week 10p-value: 0.125695% CI: [-6.6, 26.4]Chan and Zhang (1999) method
Comparison: Week 10p-value: 0.003895% CI: [7, 44.8]Chan and Zhang (1999) method
Comparison: Week 10p-value: 0.000795% CI: [12.8, 52.6]Chan and Zhang (1999) method
Secondary

Percentage of Participants With PGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis Only

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). 95% confidence interval was based on Blyth-Still-Casella method.

Time frame: Week 1, 2, 4, 6, 8, 10 and 12

Population: ITT analysis set included all participants randomly assigned to study intervention. For this OM, data collection was not planned for the 3 arms of AD Vehicle QD, AD PF-07038124 0.01% QD and AD PF-07038124 0.03% QD.

ArmMeasureGroupValue (NUMBER)
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 10 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 60 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 40 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 20 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 1211.8 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 108.8 Percentage of participants
Atopic Dermatitis: Vehicle OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 80 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 10 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 89.1 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 1015.2 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 1215.2 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 26.1 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 46.1 Percentage of participants
Atopic Dermatitis: PF-07038124 0.01% OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 615.2 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 417.1 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 1034.3 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 12.9 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 1240.0 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 828.6 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 25.7 Percentage of participants
Atopic Dermatitis: PF-07038124 0.03% OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 617.1 Percentage of participants
Psoriasis: PF-07038124 0.06% OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 29.1 Percentage of participants
Psoriasis: PF-07038124 0.06% OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 415.2 Percentage of participants
Psoriasis: PF-07038124 0.06% OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 624.2 Percentage of participants
Psoriasis: PF-07038124 0.06% OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 1245.5 Percentage of participants
Psoriasis: PF-07038124 0.06% OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 827.3 Percentage of participants
Psoriasis: PF-07038124 0.06% OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 1039.4 Percentage of participants
Psoriasis: PF-07038124 0.06% OintmentPercentage of Participants With PGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis OnlyWeek 13.0 Percentage of participants
Comparison: Week 4p-value: 0.099395% CI: [-4.9, 20.7]Chan and Zhang (1999) method
Comparison: Week 2p-value: 0.043695% CI: [-2.1, 24.3]Chan and Zhang (1999) method
Comparison: Week 1p-value: 195% CI: [-10.6, 11]Chan and Zhang (1999) method
Comparison: Week 1p-value: 0.269795% CI: [-7.8, 14.9]Chan and Zhang (1999) method
Comparison: Week 1p-value: 0.257895% CI: [-7.8, 15.8]Chan and Zhang (1999) method
Comparison: Week 2p-value: 0.099395% CI: [-4.9, 20.7]Chan and Zhang (1999) method
Comparison: Week 2p-value: 0.11495% CI: [-5.3, 19.2]Chan and Zhang (1999) method
Comparison: Week 4p-value: 0.007195% CI: [4.9, 33.9]Chan and Zhang (1999) method
Comparison: Week 4p-value: 0.010495% CI: [3.2, 32]Chan and Zhang (1999) method
Comparison: Week 6p-value: 0.010495% CI: [3.2, 32]Chan and Zhang (1999) method
Comparison: Week 6p-value: 0.007195% CI: [4.9, 33.9]Chan and Zhang (1999) method
Comparison: Week 6p-value: 0.001195% CI: [10.4, 42.3]Chan and Zhang (1999) method
Comparison: Week 8p-value: 0.043695% CI: [-2.1, 24.3]Chan and Zhang (1999) method
Comparison: Week 8p-value: 0.000395% CI: [14.2, 46.3]Chan and Zhang (1999) method
Comparison: Week 8p-value: 0.000795% CI: [12.9, 45.8]Chan and Zhang (1999) method
Comparison: Week 10p-value: 0.271295% CI: [-10.8, 24.3]Chan and Zhang (1999) method
Comparison: Week 10p-value: 0.005695% CI: [5.4, 44.8]Chan and Zhang (1999) method
Comparison: Week 10p-value: 0.001795% CI: [9.7, 50.5]Chan and Zhang (1999) method
Comparison: Week 12p-value: 0.392995% CI: [-14.9, 21.6]Chan and Zhang (1999) method
Comparison: Week 12p-value: 0.00495% CI: [7, 47.7]Chan and Zhang (1999) method
Comparison: Week 12p-value: 0.001295% CI: [10.4, 53.7]Chan and Zhang (1999) method
Secondary

Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque Psoriasis

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 (size of participant's hand with fingers in a closed position) 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 percentage (%) BSA for individuals with AD ranged from 5-40 % BSA and for individuals with Psoriasis ranged from 2-20 % BSA. Higher % BSA = greater area affected.

Time frame: Baseline, Week 1, 2, 4, 6, 8, 10 and 12

Population: ITT analysis set included all participants randomly assigned to study intervention. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints.

ArmMeasureGroupValue (MEAN)Dispersion
Atopic Dermatitis: Vehicle OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 6-20.81 Percent changeStandard Deviation 38.584
Atopic Dermatitis: Vehicle OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 1-5.70 Percent changeStandard Deviation 21.189
Atopic Dermatitis: Vehicle OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 12-19.45 Percent changeStandard Deviation 48.697
Atopic Dermatitis: Vehicle OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 2-7.71 Percent changeStandard Deviation 38.699
Atopic Dermatitis: Vehicle OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 10-27.68 Percent changeStandard Deviation 44.681
Atopic Dermatitis: Vehicle OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 4-23.51 Percent changeStandard Deviation 42.066
Atopic Dermatitis: Vehicle OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 8-21.12 Percent changeStandard Deviation 49.459
Atopic Dermatitis: PF-07038124 0.01% OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 1-7.97 Percent changeStandard Deviation 20.319
Atopic Dermatitis: PF-07038124 0.01% OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 2-19.19 Percent changeStandard Deviation 26.809
Atopic Dermatitis: PF-07038124 0.01% OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 10-36.84 Percent changeStandard Deviation 36.966
Atopic Dermatitis: PF-07038124 0.01% OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 8-35.81 Percent changeStandard Deviation 34.333
Atopic Dermatitis: PF-07038124 0.01% OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 6-33.20 Percent changeStandard Deviation 37.302
Atopic Dermatitis: PF-07038124 0.01% OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 4-30.05 Percent changeStandard Deviation 32.224
Atopic Dermatitis: PF-07038124 0.01% OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 12-40.87 Percent changeStandard Deviation 41.005
Atopic Dermatitis: PF-07038124 0.03% OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 4-36.52 Percent changeStandard Deviation 36.063
Atopic Dermatitis: PF-07038124 0.03% OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 12-46.53 Percent changeStandard Deviation 44.42
Atopic Dermatitis: PF-07038124 0.03% OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 2-25.17 Percent changeStandard Deviation 33.618
Atopic Dermatitis: PF-07038124 0.03% OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 1-11.34 Percent changeStandard Deviation 27.214
Atopic Dermatitis: PF-07038124 0.03% OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 10-36.38 Percent changeStandard Deviation 50.533
Atopic Dermatitis: PF-07038124 0.03% OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 6-41.40 Percent changeStandard Deviation 39.631
Atopic Dermatitis: PF-07038124 0.03% OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 8-43.59 Percent changeStandard Deviation 39.783
Psoriasis: PF-07038124 0.06% OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 61.19 Percent changeStandard Deviation 23.562
Psoriasis: PF-07038124 0.06% OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 1-0.57 Percent changeStandard Deviation 3.095
Psoriasis: PF-07038124 0.06% OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 2-0.09 Percent changeStandard Deviation 19.604
Psoriasis: PF-07038124 0.06% OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 43.14 Percent changeStandard Deviation 27.814
Psoriasis: PF-07038124 0.06% OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 80.75 Percent changeStandard Deviation 30.196
Psoriasis: PF-07038124 0.06% OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 10-3.77 Percent changeStandard Deviation 26.271
Psoriasis: PF-07038124 0.06% OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 12-7.61 Percent changeStandard Deviation 42.825
Psoriasis: PF-07038124 0.01% OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 12-38.16 Percent changeStandard Deviation 48.923
Psoriasis: PF-07038124 0.01% OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 1-11.80 Percent changeStandard Deviation 22.429
Psoriasis: PF-07038124 0.01% OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 6-36.37 Percent changeStandard Deviation 37.798
Psoriasis: PF-07038124 0.01% OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 4-24.40 Percent changeStandard Deviation 33.837
Psoriasis: PF-07038124 0.01% OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 2-20.88 Percent changeStandard Deviation 30.731
Psoriasis: PF-07038124 0.01% OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 10-42.72 Percent changeStandard Deviation 47.305
Psoriasis: PF-07038124 0.01% OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 8-31.98 Percent changeStandard Deviation 47.562
Psoriasis: PF-07038124 0.03% OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 12-36.13 Percent changeStandard Deviation 39.779
Psoriasis: PF-07038124 0.03% OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 1-4.08 Percent changeStandard Deviation 24.592
Psoriasis: PF-07038124 0.03% OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 2-9.60 Percent changeStandard Deviation 31.828
Psoriasis: PF-07038124 0.03% OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 8-34.04 Percent changeStandard Deviation 38.481
Psoriasis: PF-07038124 0.03% OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 1036.35 Percent changeStandard Deviation 38.176
Psoriasis: PF-07038124 0.03% OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 6-30.76 Percent changeStandard Deviation 33.598
Psoriasis: PF-07038124 0.03% OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 4-23.27 Percent changeStandard Deviation 33.581
Psoriasis: PF-07038124 0.06% OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 6-44.91 Percent changeStandard Deviation 38.196
Psoriasis: PF-07038124 0.06% OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 8-51.30 Percent changeStandard Deviation 39.21
Psoriasis: PF-07038124 0.06% OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 2-20.62 Percent changeStandard Deviation 26.613
Psoriasis: PF-07038124 0.06% OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 10-49.14 Percent changeStandard Deviation 38.319
Psoriasis: PF-07038124 0.06% OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 1-11.24 Percent changeStandard Deviation 23.946
Psoriasis: PF-07038124 0.06% OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 12-60.83 Percent changeStandard Deviation 39.223
Psoriasis: PF-07038124 0.06% OintmentPercent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque PsoriasisWeek 4-33.16 Percent changeStandard Deviation 32.929
Secondary

Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis Only

EASI quantified severity of AD based on severity of lesion clinical signs and percentage (%) of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema \[E\], induration/papulation \[I\], excoriation \[Ex\] and lichenification \[L\]) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % 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; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score=0.0 to 72.0, higher scores indicate greater severity of AD. 95% confidence interval was based on Blyth-Still-Casella method.

Time frame: Baseline, Week 1, 2, 4, 6, 8, 10 and 12

Population: ITT analysis set included all participants randomly assigned to study intervention. Here, 'Number Analyzed' signifies participants evaluable for the specified rows. For this OM, data collection was not planned for the 4 arms of Psoriasis Vehicle QD, Psoriasis PF-07038124 0.01% QD, Psoriasis PF-07038124 0.03% and Psoriasis PF-07038124 0.06% ointment.

ArmMeasureGroupValue (MEAN)Dispersion
Atopic Dermatitis: Vehicle OintmentPercent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 1-10.07 Percent changeStandard Deviation 35.34
Atopic Dermatitis: Vehicle OintmentPercent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 4-31.06 Percent changeStandard Deviation 37.602
Atopic Dermatitis: Vehicle OintmentPercent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 6-33.89 Percent changeStandard Deviation 41.636
Atopic Dermatitis: Vehicle OintmentPercent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 2-20.10 Percent changeStandard Deviation 35.277
Atopic Dermatitis: Vehicle OintmentPercent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 12-36.05 Percent changeStandard Deviation 50.08
Atopic Dermatitis: Vehicle OintmentPercent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 8-33.85 Percent changeStandard Deviation 41.95
Atopic Dermatitis: Vehicle OintmentPercent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 10-41.88 Percent changeStandard Deviation 39.244
Atopic Dermatitis: PF-07038124 0.01% OintmentPercent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 4-47.23 Percent changeStandard Deviation 28.432
Atopic Dermatitis: PF-07038124 0.01% OintmentPercent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 6-47.89 Percent changeStandard Deviation 34.117
Atopic Dermatitis: PF-07038124 0.01% OintmentPercent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 1055.70 Percent changeStandard Deviation 29.25
Atopic Dermatitis: PF-07038124 0.01% OintmentPercent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 8-53.67 Percent changeStandard Deviation 30.285
Atopic Dermatitis: PF-07038124 0.01% OintmentPercent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 1-24.58 Percent changeStandard Deviation 26.168
Atopic Dermatitis: PF-07038124 0.01% OintmentPercent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 2-35.91 Percent changeStandard Deviation 28.57
Atopic Dermatitis: PF-07038124 0.01% OintmentPercent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 12-58.40 Percent changeStandard Deviation 29.835
Atopic Dermatitis: PF-07038124 0.03% OintmentPercent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 4-46.43 Percent changeStandard Deviation 29.199
Atopic Dermatitis: PF-07038124 0.03% OintmentPercent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 12-53.29 Percent changeStandard Deviation 38.096
Atopic Dermatitis: PF-07038124 0.03% OintmentPercent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 2-35.35 Percent changeStandard Deviation 30.467
Atopic Dermatitis: PF-07038124 0.03% OintmentPercent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 6-51.96 Percent changeStandard Deviation 32.322
Atopic Dermatitis: PF-07038124 0.03% OintmentPercent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 8-53.44 Percent changeStandard Deviation 29.639
Atopic Dermatitis: PF-07038124 0.03% OintmentPercent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 1-21.07 Percent changeStandard Deviation 27.609
Atopic Dermatitis: PF-07038124 0.03% OintmentPercent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis OnlyWeek 10-53.34 Percent changeStandard Deviation 35.171

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026