A Study of Crisaborole Ointment 2% in Adult Japanese Healthy Subjects and Adult Japanese Subjects With Mild To Moderate Atopic Dermatitis
Condition: Healthy; Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Crisaborole ointment 2%; Vehicle
Intervention description: Crisaborole ointment 2%; Vehicle
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 32.0
Sex: All
Minimum age: 20 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      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.
    

Eligibility criteria:

        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.