Evaluation of Skin Irritation Potential With PF-06700841 Cream Formulation Using Negative Control in Adult Japanese Healthy Participants
Status and phase
Completed
Phase 1
Conditions
Healthy
Treatments
Drug: White petrolatum
Drug: PF-06700841 cream
Details and patient eligibility
About
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.
Enrollment
20 patients
Sex
All
Ages
20 to 55 years old
Volunteers
Accepts Healthy Volunteers
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.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
20 participants in 6 patient groups
PF-06700841 cream 0%
Experimental group
Description:
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
Treatment:
Drug: PF-06700841 cream
PF-06700841 cream 0.1%
Experimental group
Description:
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
Treatment:
Drug: PF-06700841 cream
PF-06700841 cream 0.3%
Experimental group
Description:
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
Treatment:
Drug: PF-06700841 cream
PF-06700841 cream 1%
Experimental group
Description:
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
Treatment:
Drug: PF-06700841 cream
PF-06700841 cream 3%
Experimental group
Description:
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
Treatment:
Drug: PF-06700841 cream
White petrolatum
Experimental group
Description:
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
Treatment:
Drug: White petrolatum
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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