Evaluation of Skin Irritation Potential With PF-06700841 Cream Formulation Using Negative Control in Adult Japanese Healthy Participants

Study Overview
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Brief Summary
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This is a Phase 1, single center, randomized, vehicle and white petrolatum controlled, evaluator blinded study to assess the skin irritation potential with a range of concentrations of PF-06700841 cream including vehicle and empty patch with white petrolatum under occlusive conditions in adult Japanese healthy participants.

Official Title
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A PHASE 1, SINGLE-CENTER, RANDOMIZED, VEHICLE AND WHITE PETROLATUM CONTROLLED, EVALUATOR BLINDED STUDY TO ASSESS THE SKIN IRRITATION POTENTIAL WITH A RANGE OF CONCENTRATIONS OF PF-06700841 CREAM IN ADULT JAPANESE HEALTHY PARTICIPANTS

Conditions
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Healthy

Intervention / Treatment
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* Drug: PF-06700841 cream
* Drug: White petrolatum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female participants must be 20 to 55 years of age, inclusive, at the time of signing the informed consent document. Body mass index (BMI) of 17.5 to 25 kg/m2; and a total body weight >50 kg (110 lb). Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease. Participants who have any visible skin condition at the application site which, in the opinion of the investigative personnel, will interfere with the evaluation of the test site reaction. Participants who have psoriasis and/or active AD/eczema/urticaria. Participants who have a history of AD. Participants who have damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations of the test site. History of known or suspected intolerance to any of the ingredients of the investigational products, adhesive tape/plaster, or the test patches.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-06700841 cream 0%<br>All participants will have 6 application sites where 6 patches of investigational products will be completely randomly assigned, for the purpose of determining irritation potential | Drug: PF-06700841 cream<br>* PF-06700841 will be applied topically<br>* Other names: PF-06700841 cream 0% is Vehicle;|
| Experimental: PF-06700841 cream 0.1%<br>All participants will have 6 application sites where 6 patches of investigational products will be completely randomly assigned, for the purpose of determining irritation potential | Drug: PF-06700841 cream<br>* PF-06700841 will be applied topically<br>* Other names: PF-06700841 cream 0% is Vehicle;|
| Experimental: PF-06700841 cream 0.3%<br>All participants will have 6 application sites where 6 patches of investigational products will be completely randomly assigned, for the purpose of determining irritation potential | Drug: PF-06700841 cream<br>* PF-06700841 will be applied topically<br>* Other names: PF-06700841 cream 0% is Vehicle;|
| Experimental: PF-06700841 cream 1%<br>All participants will have 6 application sites where 6 patches of investigational products will be completely randomly assigned, for the purpose of determining irritation potential | Drug: PF-06700841 cream<br>* PF-06700841 will be applied topically<br>* Other names: PF-06700841 cream 0% is Vehicle;|
| Experimental: PF-06700841 cream 3%<br>All participants will have 6 application sites where 6 patches of investigational products will be completely randomly assigned, for the purpose of determining irritation potential | Drug: PF-06700841 cream<br>* PF-06700841 will be applied topically<br>* Other names: PF-06700841 cream 0% is Vehicle;|
| Experimental: White petrolatum<br>All participants will have 6 application sites where 6 patches of investigational products will be completely randomly assigned, for the purpose of determining irritation potential | Drug: White petrolatum<br>* White petrolatum will be applied topically<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of participants who have skin irritation grade equal to or greater than two plus (++) up to Day 4 | Skin irritation grade is defined as following: no reaction (-); slight erythema (+-); erythema (+); erythema + edema, papules (++); erythema + edema + papules + vesicles (small blisters) (+++) ; large blisters (++++) | Up to Day 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of participants who have skin irritation grade equal to or greater than two plus (++) on each assessment day (Day 3 and Day 4) | Skin irritation grade is defined as following: no reaction (-); slight erythema (+-); erythema (+); erythema + edema, papules (++); erythema + edema + papules + vesicles (small blisters) (+++) ; large blisters (++++) | Day 3 and Day 4 | 
| The number of the maximum skin irritation score reported up to Day 4 by treatment | Skin irritation score is defined as following: no reaction (0); slight erythema (0.5); erythema (1); erythema + edema, papules (2); erythema + edema + papules + vesicles (small blisters) (3) ; large blisters (4) | Up to Day 4 | 
| The percentage of the maximum skin irritation score reported up to Day 4 by treatment | Skin irritation score is defined as following: no reaction (0); slight erythema (0.5); erythema (1); erythema + edema, papules (2); erythema + edema + papules + vesicles (small blisters) (3) ; large blisters (4) | Up to Day 4 | 
| The number of each skin irritation score reported by treatment on each assessment day | Skin irritation score is defined as following: no reaction (0); slight erythema (0.5); erythema (1); erythema + edema, papules (2); erythema + edema + papules + vesicles (small blisters) (3) ; large blisters (4) | Day 3 and Day 4 | 
| The percentage of each skin irritation score reported by treatment on each assessment day | Skin irritation score is defined as following: no reaction (0); slight erythema (0.5); erythema (1); erythema + edema, papules (2); erythema + edema + papules + vesicles (small blisters) (3) ; large blisters (4) | Day 3 and Day 4 | 
| Number of Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) |  | Baseline up to Day 35 | 
| Number of Participants Discontinuation Due to AEs |  | Baseline up to Day 35 |