A Study of Crisaborole Ointment 2% in Adult Japanese Healthy Subjects and Adult Japanese Subjects With Mild To Moderate Atopic Dermatitis

Pfizer

Status and phase: Completed; Phase 1

Conditions: Atopic Dermatitis; Healthy

Treatments: Drug: Vehicle; Drug: Crisaborole ointment 2%

Study type: Interventional

Funder types: Industry

Identifiers

NCT03260595

C3291029

Details and patient eligibility

About

This is a Phase 1 parallel-cohort study of crisaborole ointment 2% to evaluate the skin irritation potential in adult Japanese healthy subjects in Cohort 1, and to evaluate the safety, tolerability and PK in adult Japanese subjects with mild to moderate AD in Cohort 2.

Enrollment: 32 patients

Sex: All

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Cohort 1

1. Healthy male Japanese subjects who, at the time of screening, are between the ages of 20 and 55 years, inclusive.
2. Healthy skin on which reddening can be easily recognized in the area of the test fields.

Cohort 2

1. Male or female Japanese subjects aged 20 years to 55 years (inclusive) at the time of screening, and in generally good health except for AD.
2. Diagnosis of AD based on the criteria of Hanifin and Rajka (1980).
3. Has at least 25% Treatable %BSA on Day 1 (excluding the scalp and designated venous access areas).
4. Has an Investigator's static global assessment (ISGA) score of Mild (2) or Moderate (3) on Day 1.

Exclusion criteria

Cohort 1

1. Subjects who have any visible skin disease at the application site which, in the opinion of the investigative personnel, will interfere with the evaluation of the test site reaction.
2. Subjects who have psoriasis and/or active AD/eczema.
3. Subjects who have a history of AD.
4. Subjects 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.
5. Known sensitivity to any of the components of the investigational products.
6. History of the rash to the adhesive plaster, contact dermatitis to metal, or cosmetic and household articles.

Cohort 2

1. Has any clinically significant medical disorder, condition, disease (including active or potentially recurrent dermatological conditions other than AD), significant physical examination or laboratory findings that may interfere with study objectives, in the Investigator's opinion.
2. Has unstable AD or a consistent requirement for strong to strongest potency topical corticosteroids to manage AD signs and symptoms.
3. Has a significant active systemic or localized infection, including known actively infected AD.
4. Has a history or evidence of clinically significant or severe allergies (eg, seasonal, pet dander, environmental, food) requiring acute or chronic treatment.
5. Has recent or anticipated concomitant use of topical or systemic therapies that might alter the course of AD.
6. Has a history of recent (within 4 weeks of Day 1) sunbathing, tanning bed use, or ultraviolet (UV) light B therapy (UVB) or psoralen plus UVA [PUVA]).
7. Has a known sensitivity to any of the components of crisaborole ointment 2%.
8. Pregnant female subjects; breastfeeding female subjects; female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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32 participants in 2 patient groups, including a placebo group

Crisaborole ointment 2%

Experimental group

Treatment:

Drug: Crisaborole ointment 2%

Vehicle

Placebo Comparator group

Treatment:

Drug: Vehicle