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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
263
Atopic Dermatitis and Plaque Psoriasis
Atopic Dermatitis and Plaque Psoriasis
Atopic Dermatitis and Plaque Psoriasis
PF-07038124 ointment 0.06% (Plaque Psoriasis only)
California Dermatology & Clinical Research Institute
Encinitas, California, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Renaissance Research and Medical Group
Cape Coral, Florida, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Jacksonville, Florida, United States
ForCare Clinical Research
Tampa, Florida, United States
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
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
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
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
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
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
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
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
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
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
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
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
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
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)
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)
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
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
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
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
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