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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PF-06700841 cream; Drug: White petrolatum

• Registration Number: NCT03916250
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-20
• Study Start: 2019-03-23
• Study First Submitted QC: 2019-04-12
• Primary Completion: 2019-04-15
• Study First Posted: 2019-04-16
• Status Verified: 2019-05
• Study Completion: 2019-05-12
• Last Update Submitted: 2019-05-23
• Last Update Posted: 2019-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PF-06700841 cream 0.1%	PF-06700841 cream	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
PF-06700841 cream 0.3%	PF-06700841 cream	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
PF-06700841 cream 1%	PF-06700841 cream	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
PF-06700841 cream 3%	PF-06700841 cream	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
PF-06700841 cream 0%	PF-06700841 cream	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
White petrolatum	White petrolatum	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 (++++)
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 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)
Number of Participants Discontinuation Due to AEs	Baseline up to Day 35
Number of Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)	Baseline up to Day 35

Trial Locations

Locations (1)

Medical Corporation Heishinkai OPHAC Hospital; 🇯🇵 Osaka-shi, Osaka, Japan