Healthy
Conditions
Brief summary
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.
Interventions
DRUGPF-06700841 cream
PF-06700841 will be applied topically
DRUGWhite petrolatum
White petrolatum will be applied topically
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of participants who have skin irritation grade equal to or greater than two plus (++) up to Day 4 | 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 (++++) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of the maximum skin irritation score reported up to Day 4 by treatment | Up to Day 4 | 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) |
| The percentage of the maximum skin irritation score reported up to Day 4 by treatment | Up to Day 4 | 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) |
| The number of each skin irritation score reported by treatment on each assessment day | Day 3 and Day 4 | 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) |
| 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) | 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 (++++) |
| 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 | — |
| The percentage of each skin irritation score reported by treatment on each assessment day | Day 3 and Day 4 | 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) |
Countries
Japan
Outcome results
None listed