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

NCT03916250 | Completed Phase 1

• 1 other identifier: B7931029
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

• The number of the maximum skin irritation score reported up to Day 4 by treatment

  Up to Day 4

• The percentage of the maximum skin irritation score reported up to Day 4 by treatment

  Up to Day 4

• The number of each skin irritation score reported by treatment on each assessment day

  Day 3 and Day 4

• The percentage of each skin irritation score reported by treatment on each assessment day

  Day 3 and Day 4

Study Arms (6)

PF-06700841 cream 0%

EXPERIMENTAL

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

PF-06700841 cream 0.1%

EXPERIMENTAL

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

PF-06700841 cream 0.3%

EXPERIMENTAL

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

PF-06700841 cream 1%

EXPERIMENTAL

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

PF-06700841 cream 3%

EXPERIMENTAL

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

White petrolatum

EXPERIMENTAL

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

Interventions

PF-06700841 cream DRUG

PF-06700841 will be applied topically

Also known as: PF-06700841 cream 0% is Vehicle

PF-06700841 cream 0%; PF-06700841 cream 0.1%; PF-06700841 cream 0.3%; PF-06700841 cream 1%; PF-06700841 cream 3%

White petrolatum DRUG

White petrolatum will be applied topically

White petrolatum

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Medical Corporation Heishinkai OPHAC Hospital

Osaka, Osaka, 532-0003, Japan

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Petrolatum

Intervention Hierarchy (Ancestors)

Hydrocarbons; Organic Chemicals

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2019
• First Posted: April 16, 2019
• Study Start: March 23, 2019
• Primary Completion: April 15, 2019
• Study Completion: May 12, 2019
• Last Updated: May 24, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)