Atopic Dermatitis, Plaque Psoriasis
Conditions
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
Atopic Dermatitis and Plaque Psoriasis
Atopic Dermatitis and Plaque Psoriasis
Atopic Dermatitis and Plaque Psoriasis
PF-07038124 ointment 0.06% (Plaque Psoriasis only)
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline, Week 12 | 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. |
| 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 | Baseline, Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline, Week 1, 2, 4, 6, 8, and 10 | 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. |
| 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 | Baseline, Week 1, 2, 4, 6, 8, and 10 | 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. |
| 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 | Week 1, 2, 4, 6, 8, 10 and 12 | 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. |
| 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 | Week 1, 2, 4, 6, 8, 10 and 12 | 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. |
| 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 | Baseline, Week 1, 2, 4, 6, 8, 10 and 12 | 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. |
| 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 | Baseline, Week 1, 2, 4, 6, 8, 10 and 12 | 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. |
| 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 | Baseline, Week 1, 2, 4, 6, 8, 10 and 12 | 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). |
| 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 | Baseline, Week 1, 2, 4, 6, 8, 10 and 12 | 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. |
| 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 | Baseline, Week 1, 2, 4, 6, 8, 10 and 12 | 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. |
| Number of Participants With Treatment Emergent Adverse Events (AEs): Participants With Atopic Dermatitis and Plaque Psoriasis | From 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 Psoriasis | From 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 Psoriasis | From start of study treatment (Day 1) up to Week 12 | 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. |
| Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG): Participants With Atopic Dermatitis and Plaque Psoriasis | From start of study treatment (Day 1) up to Week 12 | 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. |
| Number of Participants With Laboratory Abnormalities: Participants With Atopic Dermatitis and Plaque Psoriasis | From start of study treatment (Day 1) up to Week 12 | 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. |
| Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis | From start of study treatment (Day 1) up to Week 12 | 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 \[if still in place\]. |
| 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 | Week 1, 2, 4, 6, 8, 10 and 12 | 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). |
| 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 | Baseline, Week 1, 2, 4, 6, 8, 10 and 12 | 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. |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 263 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Follow-up (up to 5 Weeks) | Lost to Follow-up | 1 | 0 | 1 | 0 | 1 | 1 | 2 |
| Follow-up (up to 5 Weeks) | Other | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Follow-up (up to 5 Weeks) | Physician's decision | 2 | 0 | 2 | 0 | 0 | 0 | 0 |
| Follow-up (up to 5 Weeks) | Protocol Violation | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Follow-up (up to 5 Weeks) | Withdrawal by Subject | 1 | 0 | 1 | 0 | 0 | 1 | 0 |
| Treatment (12 Weeks) | Lost to Follow-up | 0 | 2 | 2 | 1 | 1 | 1 | 0 |
| Treatment (12 Weeks) | Other | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Treatment (12 Weeks) | Physician Decision | 4 | 1 | 3 | 0 | 0 | 1 | 0 |
| Treatment (12 Weeks) | Pregnancy | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Treatment (12 Weeks) | Withdrawal by parent/guardian | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Treatment (12 Weeks) | Withdrawal by Subject | 8 | 4 | 7 | 8 | 4 | 3 | 3 |
Baseline characteristics
| Characteristic | Atopic Dermatitis: Vehicle Ointment | Atopic Dermatitis: PF-07038124 0.01% Ointment | Atopic Dermatitis: PF-07038124 0.03% Ointment | Psoriasis: PF-07038124 Vehicle Ointment | Psoriasis: PF-07038124 0.01% Ointment | Psoriasis: PF-07038124 0.03% Ointment | Psoriasis: PF-07038124 0.06% Ointment | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 44.8 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 Participants | 11 Participants | 8 Participants | 16 Participants | 11 Participants | 7 Participants | 6 Participants | 66 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants | 29 Participants | 32 Participants | 17 Participants | 22 Participants | 25 Participants | 27 Participants | 187 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 2 Participants | 1 Participants | 0 Participants | 3 Participants | 0 Participants | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 8 Participants | 13 Participants | 7 Participants | 4 Participants | 8 Participants | 12 Participants | 60 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 11 Participants | 12 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 39 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) White | 23 Participants | 20 Participants | 17 Participants | 25 Participants | 27 Participants | 25 Participants | 20 Participants | 157 Participants |
| Sex: Female, Male Female | 23 Participants | 25 Participants | 23 Participants | 14 Participants | 13 Participants | 14 Participants | 15 Participants | 127 Participants |
| Sex: Female, Male Male | 21 Participants | 17 Participants | 19 Participants | 20 Participants | 20 Participants | 21 Participants | 18 Participants | 136 Participants |
Adverse events
| Event type | EG000 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 / 44 | 0 / 42 | 0 / 42 | 0 / 34 | 0 / 33 | 0 / 35 | 0 / 33 |
| other Total, other adverse events | 0 / 44 | 5 / 42 | 2 / 42 | 1 / 34 | 5 / 33 | 2 / 35 | 7 / 33 |
| serious Total, serious adverse events | 0 / 44 | 1 / 42 | 1 / 42 | 0 / 34 | 0 / 33 | 0 / 35 | 1 / 33 |
Outcome results
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Atopic Dermatitis: Vehicle Ointment | 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 | 11.4 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | 23.8 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | 21.4 Percentage of participants |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Atopic Dermatitis: Vehicle Ointment | 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 | 8.8 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | 15.2 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | 37.1 Percentage of participants |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | 45.5 Percentage of participants |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 1 | -0.60 Units on a scale | Standard Deviation 1.796 |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 10 | -3.93 Units on a scale | Standard Deviation 3.398 |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 8 | -3.23 Units on a scale | Standard Deviation 3.584 |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 2 | -1.53 Units on a scale | Standard Deviation 2.192 |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 12 | -3.57 Units on a scale | Standard Deviation 3.946 |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 4 | -1.70 Units on a scale | Standard Deviation 3.245 |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 6 | -2.13 Units on a scale | Standard Deviation 3.451 |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 10 | -4.45 Units on a scale | Standard Deviation 3.486 |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 6 | -3.65 Units on a scale | Standard Deviation 2.639 |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 4 | -3.09 Units on a scale | Standard Deviation 2.332 |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 8 | -3.70 Units on a scale | Standard Deviation 3.059 |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 12 | -4.53 Units on a scale | Standard Deviation 3.556 |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 2 | -2.75 Units on a scale | Standard Deviation 2.315 |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 1 | -1.74 Units on a scale | Standard Deviation 1.529 |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 6 | -4.54 Units on a scale | Standard Deviation 3.143 |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 1 | -1.69 Units on a scale | Standard Deviation 2.053 |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 2 | -2.41 Units on a scale | Standard Deviation 2.496 |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 4 | -3.50 Units on a scale | Standard Deviation 2.861 |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 8 | -4.73 Units on a scale | Standard Deviation 3.383 |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 10 | -4.87 Units on a scale | Standard Deviation 3.369 |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 12 | -4.84 Units on a scale | Standard Deviation 3.53 |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 4 | -4.77 Units on a scale | Standard Deviation 3.694 |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 12 | -6.07 Units on a scale | Standard Deviation 4.058 |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 10 | -5.74 Units on a scale | Standard Deviation 3.973 |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 2 | -3.84 Units on a scale | Standard Deviation 3.357 |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 1 | -2.66 Units on a scale | Standard Deviation 2.064 |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 8 | -6.51 Units on a scale | Standard Deviation 4.002 |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 6 | -5.39 Units on a scale | Standard Deviation 3.797 |
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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Atopic Dermatitis: Vehicle Ointment | Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis | Missing | 0 Participants |
| Atopic Dermatitis: Vehicle Ointment | Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis | Grade 1 (Mild) | 0 Participants |
| Atopic Dermatitis: Vehicle Ointment | Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis | Grade 3 (Severe) | 0 Participants |
| Atopic Dermatitis: Vehicle Ointment | Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis | Grade 0 (None) | 44 Participants |
| Atopic Dermatitis: Vehicle Ointment | Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis | Grade 2 (Moderate) | 0 Participants |
| Atopic Dermatitis: Vehicle Ointment | Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis | Grade 4 (Very severe) | 0 Participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis | Grade 0 (None) | 42 Participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis | Grade 3 (Severe) | 0 Participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis | Missing | 0 Participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis | Grade 1 (Mild) | 0 Participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis | Grade 4 (Very severe) | 0 Participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis | Grade 2 (Moderate) | 0 Participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis | Grade 4 (Very severe) | 0 Participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis | Grade 2 (Moderate) | 0 Participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis | Missing | 0 Participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis | Grade 3 (Severe) | 0 Participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis | Grade 0 (None) | 42 Participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis | Grade 1 (Mild) | 0 Participants |
| Psoriasis: PF-07038124 0.06% Ointment | Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis | Grade 4 (Very severe) | 0 Participants |
| Psoriasis: PF-07038124 0.06% Ointment | Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis | Grade 0 (None) | 32 Participants |
| Psoriasis: PF-07038124 0.06% Ointment | Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis | Grade 1 (Mild) | 1 Participants |
| Psoriasis: PF-07038124 0.06% Ointment | Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis | Grade 2 (Moderate) | 0 Participants |
| Psoriasis: PF-07038124 0.06% Ointment | Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis | Grade 3 (Severe) | 0 Participants |
| Psoriasis: PF-07038124 0.06% Ointment | Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis | Missing | 1 Participants |
| Psoriasis: PF-07038124 0.01% Ointment | Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis | Grade 3 (Severe) | 0 Participants |
| Psoriasis: PF-07038124 0.01% Ointment | Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis | Grade 1 (Mild) | 1 Participants |
| Psoriasis: PF-07038124 0.01% Ointment | Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis | Grade 4 (Very severe) | 0 Participants |
| Psoriasis: PF-07038124 0.01% Ointment | Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis | Missing | 0 Participants |
| Psoriasis: PF-07038124 0.01% Ointment | Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis | Grade 2 (Moderate) | 0 Participants |
| Psoriasis: PF-07038124 0.01% Ointment | Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis | Grade 0 (None) | 32 Participants |
| Psoriasis: PF-07038124 0.03% Ointment | Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis | Grade 2 (Moderate) | 0 Participants |
| Psoriasis: PF-07038124 0.03% Ointment | Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis | Grade 3 (Severe) | 0 Participants |
| Psoriasis: PF-07038124 0.03% Ointment | Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis | Grade 1 (Mild) | 1 Participants |
| Psoriasis: PF-07038124 0.03% Ointment | Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis | Grade 4 (Very severe) | 0 Participants |
| Psoriasis: PF-07038124 0.03% Ointment | Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis | Grade 0 (None) | 34 Participants |
| Psoriasis: PF-07038124 0.03% Ointment | Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis | Missing | 0 Participants |
| Psoriasis: PF-07038124 0.06% Ointment | Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis | Grade 2 (Moderate) | 0 Participants |
| Psoriasis: PF-07038124 0.06% Ointment | Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis | Grade 1 (Mild) | 0 Participants |
| Psoriasis: PF-07038124 0.06% Ointment | Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis | Missing | 0 Participants |
| Psoriasis: PF-07038124 0.06% Ointment | Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis | Grade 3 (Severe) | 0 Participants |
| Psoriasis: PF-07038124 0.06% Ointment | Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis | Grade 4 (Very severe) | 0 Participants |
| Psoriasis: PF-07038124 0.06% Ointment | Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis | Grade 0 (None) | 33 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Atopic Dermatitis: Vehicle Ointment | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG): Participants With Atopic Dermatitis and Plaque Psoriasis | 0 Participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG): Participants With Atopic Dermatitis and Plaque Psoriasis | 0 Participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG): Participants With Atopic Dermatitis and Plaque Psoriasis | 0 Participants |
| Psoriasis: PF-07038124 0.06% Ointment | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG): Participants With Atopic Dermatitis and Plaque Psoriasis | 0 Participants |
| Psoriasis: PF-07038124 0.01% Ointment | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG): Participants With Atopic Dermatitis and Plaque Psoriasis | 0 Participants |
| Psoriasis: PF-07038124 0.03% Ointment | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG): Participants With Atopic Dermatitis and Plaque Psoriasis | 0 Participants |
| Psoriasis: PF-07038124 0.06% Ointment | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG): Participants With Atopic Dermatitis and Plaque Psoriasis | 0 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Atopic Dermatitis: Vehicle Ointment | Number of Participants With Clinically Significant Changes in Vital Signs: Participants With Atopic Dermatitis and Plaque Psoriasis | 0 Participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | Number of Participants With Clinically Significant Changes in Vital Signs: Participants With Atopic Dermatitis and Plaque Psoriasis | 0 Participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | Number of Participants With Clinically Significant Changes in Vital Signs: Participants With Atopic Dermatitis and Plaque Psoriasis | 0 Participants |
| Psoriasis: PF-07038124 0.06% Ointment | Number of Participants With Clinically Significant Changes in Vital Signs: Participants With Atopic Dermatitis and Plaque Psoriasis | 0 Participants |
| Psoriasis: PF-07038124 0.01% Ointment | Number of Participants With Clinically Significant Changes in Vital Signs: Participants With Atopic Dermatitis and Plaque Psoriasis | 0 Participants |
| Psoriasis: PF-07038124 0.03% Ointment | Number of Participants With Clinically Significant Changes in Vital Signs: Participants With Atopic Dermatitis and Plaque Psoriasis | 0 Participants |
| Psoriasis: PF-07038124 0.06% Ointment | Number of Participants With Clinically Significant Changes in Vital Signs: Participants With Atopic Dermatitis and Plaque Psoriasis | 0 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Atopic Dermatitis: Vehicle Ointment | Number of Participants With Laboratory Abnormalities: Participants With Atopic Dermatitis and Plaque Psoriasis | 18 Participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | Number of Participants With Laboratory Abnormalities: Participants With Atopic Dermatitis and Plaque Psoriasis | 27 Participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | Number of Participants With Laboratory Abnormalities: Participants With Atopic Dermatitis and Plaque Psoriasis | 18 Participants |
| Psoriasis: PF-07038124 0.06% Ointment | Number of Participants With Laboratory Abnormalities: Participants With Atopic Dermatitis and Plaque Psoriasis | 14 Participants |
| Psoriasis: PF-07038124 0.01% Ointment | Number of Participants With Laboratory Abnormalities: Participants With Atopic Dermatitis and Plaque Psoriasis | 14 Participants |
| Psoriasis: PF-07038124 0.03% Ointment | Number of Participants With Laboratory Abnormalities: Participants With Atopic Dermatitis and Plaque Psoriasis | 13 Participants |
| Psoriasis: PF-07038124 0.06% Ointment | Number of Participants With Laboratory Abnormalities: Participants With Atopic Dermatitis and Plaque Psoriasis | 15 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Atopic Dermatitis: Vehicle Ointment | Number of Participants With Serious Adverse Events (SAEs): Participants With Atopic Dermatitis and Plaque Psoriasis | 0 Participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | Number of Participants With Serious Adverse Events (SAEs): Participants With Atopic Dermatitis and Plaque Psoriasis | 1 Participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | Number of Participants With Serious Adverse Events (SAEs): Participants With Atopic Dermatitis and Plaque Psoriasis | 1 Participants |
| Psoriasis: PF-07038124 0.06% Ointment | Number of Participants With Serious Adverse Events (SAEs): Participants With Atopic Dermatitis and Plaque Psoriasis | 0 Participants |
| Psoriasis: PF-07038124 0.01% Ointment | Number of Participants With Serious Adverse Events (SAEs): Participants With Atopic Dermatitis and Plaque Psoriasis | 0 Participants |
| Psoriasis: PF-07038124 0.03% Ointment | Number of Participants With Serious Adverse Events (SAEs): Participants With Atopic Dermatitis and Plaque Psoriasis | 0 Participants |
| Psoriasis: PF-07038124 0.06% Ointment | Number of Participants With Serious Adverse Events (SAEs): Participants With Atopic Dermatitis and Plaque Psoriasis | 1 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Atopic Dermatitis: Vehicle Ointment | Number of Participants With Treatment Emergent Adverse Events (AEs): Participants With Atopic Dermatitis and Plaque Psoriasis | 20 Participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | Number of Participants With Treatment Emergent Adverse Events (AEs): Participants With Atopic Dermatitis and Plaque Psoriasis | 28 Participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | Number of Participants With Treatment Emergent Adverse Events (AEs): Participants With Atopic Dermatitis and Plaque Psoriasis | 19 Participants |
| Psoriasis: PF-07038124 0.06% Ointment | Number of Participants With Treatment Emergent Adverse Events (AEs): Participants With Atopic Dermatitis and Plaque Psoriasis | 9 Participants |
| Psoriasis: PF-07038124 0.01% Ointment | Number of Participants With Treatment Emergent Adverse Events (AEs): Participants With Atopic Dermatitis and Plaque Psoriasis | 13 Participants |
| Psoriasis: PF-07038124 0.03% Ointment | Number of Participants With Treatment Emergent Adverse Events (AEs): Participants With Atopic Dermatitis and Plaque Psoriasis | 11 Participants |
| Psoriasis: PF-07038124 0.06% Ointment | Number of Participants With Treatment Emergent Adverse Events (AEs): Participants With Atopic Dermatitis and Plaque Psoriasis | 19 Participants |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 10 | 17.4 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 12 | 17.4 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 4 | 8.7 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 2 | 4.3 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 1 | 4.3 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 8 | 17.4 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 6 | 4.3 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 1 | 0 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 12 | 40.9 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 8 | 40.9 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 2 | 13.6 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 6 | 31.8 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 4 | 22.7 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 10 | 36.4 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 12 | 33.3 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 1 | 12.5 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 2 | 20.8 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 4 | 25.0 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 6 | 25.0 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 8 | 25.0 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 10 | 29.2 Percentage of participants |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 6 | 42.1 Percentage of participants |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 4 | 26.3 Percentage of participants |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 12 | 47.4 Percentage of participants |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 10 | 47.4 Percentage of participants |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 2 | 21.1 Percentage of participants |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 1 | 5.3 Percentage of participants |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 8 | 52.6 Percentage of participants |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 4 | 10.0 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 12 | 15.0 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 8 | 17.5 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 6 | 17.5 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 2 | 0 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 1 | 2.5 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 10 | 17.5 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 8 | 21.1 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 1 | 5.3 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 2 | 18.4 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 4 | 23.7 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 6 | 21.1 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 10 | 23.7 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 12 | 26.3 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 8 | 29.4 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 2 | 14.7 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 12 | 35.3 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 10 | 26.5 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 1 | 0 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 6 | 26.5 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 4 | 29.4 Percentage of participants |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 2 | 2.3 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 8 | 15.9 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 6 | 13.6 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 1 | 2.3 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 12 | 13.6 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 10 | 13.6 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 4 | 11.4 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 6 | 21.4 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 1 | 2.4 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 2 | 11.9 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 4 | 11.9 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 8 | 19.0 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 10 | 21.4 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 12 | 26.2 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 8 | 14.3 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 2 | 7.1 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 12 | 28.6 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 10 | 19.0 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 6 | 16.7 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 4 | 16.7 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 1 | 4.8 Percentage of participants |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 1 | 0 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 10 | 8.8 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 8 | 2.9 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 2 | 0 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 12 | 14.7 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 4 | 0 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 6 | 0 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 10 | 30.3 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 6 | 21.2 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 4 | 15.2 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 8 | 18.2 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 12 | 27.3 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 2 | 9.1 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 1 | 3.0 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 6 | 22.9 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 1 | 0 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 2 | 2.9 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 4 | 14.3 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 8 | 25.7 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 10 | 28.6 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 12 | 25.7 Percentage of participants |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 4 | 21.2 Percentage of participants |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 12 | 51.5 Percentage of participants |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 10 | 48.5 Percentage of participants |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 2 | 15.2 Percentage of participants |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 1 | 9.1 Percentage of participants |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 8 | 33.3 Percentage of participants |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 6 | 33.3 Percentage of participants |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 1 | 2.3 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 2 | 2.3 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 4 | 9.1 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 6 | 6.8 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 8 | 6.8 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 10 | 11.4 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 10 | 19.0 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 1 | 4.8 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 6 | 14.3 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 8 | 16.7 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 2 | 7.1 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 4 | 14.3 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 2 | 9.5 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 4 | 11.9 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 10 | 14.3 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 6 | 14.3 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 1 | 4.8 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 8 | 9.5 Percentage of participants |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 2 | 4.5 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 8 | 11.4 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 12 | 15.9 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 4 | 11.4 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 10 | 15.9 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 1 | 2.3 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 6 | 9.1 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 1 | 4.8 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 10 | 19.0 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 6 | 14.3 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 12 | 23.8 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 2 | 7.1 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 4 | 16.7 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 8 | 16.7 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 12 | 28.6 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 2 | 11.9 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 4 | 19.0 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 6 | 21.4 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 8 | 16.7 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 1 | 4.8 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 10 | 19.0 Percentage of participants |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 1 | 0 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 2 | 0 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 4 | 0 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 6 | 0 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 8 | 0 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 10 | 5.9 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 10 | 15.2 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 6 | 15.2 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 1 | 0 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 4 | 6.1 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 2 | 6.1 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 8 | 9.1 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 2 | 5.7 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 4 | 17.1 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 6 | 17.1 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 10 | 31.4 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 8 | 28.6 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 1 | 0 Percentage of participants |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 8 | 27.3 Percentage of participants |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 10 | 39.4 Percentage of participants |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 2 | 9.1 Percentage of participants |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 6 | 24.2 Percentage of participants |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 1 | 3.0 Percentage of participants |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 4 | 15.2 Percentage of participants |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 1 | 0 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 6 | 0 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 4 | 0 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 2 | 0 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 12 | 11.8 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 10 | 8.8 Percentage of participants |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 8 | 0 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 1 | 0 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 8 | 9.1 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 10 | 15.2 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 12 | 15.2 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 2 | 6.1 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 4 | 6.1 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 6 | 15.2 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 4 | 17.1 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 10 | 34.3 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 1 | 2.9 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 12 | 40.0 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 8 | 28.6 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 2 | 5.7 Percentage of participants |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 6 | 17.1 Percentage of participants |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 2 | 9.1 Percentage of participants |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 4 | 15.2 Percentage of participants |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 6 | 24.2 Percentage of participants |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 12 | 45.5 Percentage of participants |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 8 | 27.3 Percentage of participants |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 10 | 39.4 Percentage of participants |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 1 | 3.0 Percentage of participants |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 6 | -20.81 Percent change | Standard Deviation 38.584 |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 1 | -5.70 Percent change | Standard Deviation 21.189 |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 12 | -19.45 Percent change | Standard Deviation 48.697 |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 2 | -7.71 Percent change | Standard Deviation 38.699 |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 10 | -27.68 Percent change | Standard Deviation 44.681 |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 4 | -23.51 Percent change | Standard Deviation 42.066 |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 8 | -21.12 Percent change | Standard Deviation 49.459 |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 1 | -7.97 Percent change | Standard Deviation 20.319 |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 2 | -19.19 Percent change | Standard Deviation 26.809 |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 10 | -36.84 Percent change | Standard Deviation 36.966 |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 8 | -35.81 Percent change | Standard Deviation 34.333 |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 6 | -33.20 Percent change | Standard Deviation 37.302 |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 4 | -30.05 Percent change | Standard Deviation 32.224 |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 12 | -40.87 Percent change | Standard Deviation 41.005 |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 4 | -36.52 Percent change | Standard Deviation 36.063 |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 12 | -46.53 Percent change | Standard Deviation 44.42 |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 2 | -25.17 Percent change | Standard Deviation 33.618 |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 1 | -11.34 Percent change | Standard Deviation 27.214 |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 10 | -36.38 Percent change | Standard Deviation 50.533 |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 6 | -41.40 Percent change | Standard Deviation 39.631 |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 8 | -43.59 Percent change | Standard Deviation 39.783 |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 6 | 1.19 Percent change | Standard Deviation 23.562 |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 1 | -0.57 Percent change | Standard Deviation 3.095 |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 2 | -0.09 Percent change | Standard Deviation 19.604 |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 4 | 3.14 Percent change | Standard Deviation 27.814 |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 8 | 0.75 Percent change | Standard Deviation 30.196 |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 10 | -3.77 Percent change | Standard Deviation 26.271 |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 12 | -7.61 Percent change | Standard Deviation 42.825 |
| Psoriasis: PF-07038124 0.01% Ointment | 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 | Week 12 | -38.16 Percent change | Standard Deviation 48.923 |
| Psoriasis: PF-07038124 0.01% Ointment | 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 | Week 1 | -11.80 Percent change | Standard Deviation 22.429 |
| Psoriasis: PF-07038124 0.01% Ointment | 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 | Week 6 | -36.37 Percent change | Standard Deviation 37.798 |
| Psoriasis: PF-07038124 0.01% Ointment | 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 | Week 4 | -24.40 Percent change | Standard Deviation 33.837 |
| Psoriasis: PF-07038124 0.01% Ointment | 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 | Week 2 | -20.88 Percent change | Standard Deviation 30.731 |
| Psoriasis: PF-07038124 0.01% Ointment | 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 | Week 10 | -42.72 Percent change | Standard Deviation 47.305 |
| Psoriasis: PF-07038124 0.01% Ointment | 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 | Week 8 | -31.98 Percent change | Standard Deviation 47.562 |
| Psoriasis: PF-07038124 0.03% Ointment | 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 | Week 12 | -36.13 Percent change | Standard Deviation 39.779 |
| Psoriasis: PF-07038124 0.03% Ointment | 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 | Week 1 | -4.08 Percent change | Standard Deviation 24.592 |
| Psoriasis: PF-07038124 0.03% Ointment | 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 | Week 2 | -9.60 Percent change | Standard Deviation 31.828 |
| Psoriasis: PF-07038124 0.03% Ointment | 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 | Week 8 | -34.04 Percent change | Standard Deviation 38.481 |
| Psoriasis: PF-07038124 0.03% Ointment | 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 | Week 10 | 36.35 Percent change | Standard Deviation 38.176 |
| Psoriasis: PF-07038124 0.03% Ointment | 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 | Week 6 | -30.76 Percent change | Standard Deviation 33.598 |
| Psoriasis: PF-07038124 0.03% Ointment | 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 | Week 4 | -23.27 Percent change | Standard Deviation 33.581 |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 6 | -44.91 Percent change | Standard Deviation 38.196 |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 8 | -51.30 Percent change | Standard Deviation 39.21 |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 2 | -20.62 Percent change | Standard Deviation 26.613 |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 10 | -49.14 Percent change | Standard Deviation 38.319 |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 1 | -11.24 Percent change | Standard Deviation 23.946 |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 12 | -60.83 Percent change | Standard Deviation 39.223 |
| Psoriasis: PF-07038124 0.06% Ointment | 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 | Week 4 | -33.16 Percent change | Standard Deviation 32.929 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 1 | -10.07 Percent change | Standard Deviation 35.34 |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 4 | -31.06 Percent change | Standard Deviation 37.602 |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 6 | -33.89 Percent change | Standard Deviation 41.636 |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 2 | -20.10 Percent change | Standard Deviation 35.277 |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 12 | -36.05 Percent change | Standard Deviation 50.08 |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 8 | -33.85 Percent change | Standard Deviation 41.95 |
| Atopic Dermatitis: Vehicle Ointment | 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 | Week 10 | -41.88 Percent change | Standard Deviation 39.244 |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 4 | -47.23 Percent change | Standard Deviation 28.432 |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 6 | -47.89 Percent change | Standard Deviation 34.117 |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 10 | 55.70 Percent change | Standard Deviation 29.25 |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 8 | -53.67 Percent change | Standard Deviation 30.285 |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 1 | -24.58 Percent change | Standard Deviation 26.168 |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 2 | -35.91 Percent change | Standard Deviation 28.57 |
| Atopic Dermatitis: PF-07038124 0.01% Ointment | 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 | Week 12 | -58.40 Percent change | Standard Deviation 29.835 |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 4 | -46.43 Percent change | Standard Deviation 29.199 |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 12 | -53.29 Percent change | Standard Deviation 38.096 |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 2 | -35.35 Percent change | Standard Deviation 30.467 |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 6 | -51.96 Percent change | Standard Deviation 32.322 |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 8 | -53.44 Percent change | Standard Deviation 29.639 |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 1 | -21.07 Percent change | Standard Deviation 27.609 |
| Atopic Dermatitis: PF-07038124 0.03% Ointment | 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 | Week 10 | -53.34 Percent change | Standard Deviation 35.171 |