Last updated on March 2019

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Healthy | Atopic Dermatitis
  • Age: Between 20 - 55 Years
  • Gender: Male or Female
  • Other:
    Cohort 1
    Healthy male Japanese subjects who, at the time of screening, are between the ages of
    20 and 55 years, inclusive.
    Healthy skin on which reddening can be easily recognized in the area of the test
    Cohort 2
    Male or female Japanese subjects aged 20 years to 55 years (inclusive) at the time of
    creening, and in generally good health except for AD.
    Diagnosis of AD based on the criteria of Hanifin and Rajka (1980).
    Has at least 25% Treatable %BSA on Day 1 (excluding the scalp and designated venous
    access areas).
    Has an Investigator's static global assessment (ISGA) score of Mild (2) or Moderate
    (3) on Day 1.

You may not be eligible for this study if the following are true:

  • Cohort 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
    ite reaction.
    Subjects who have psoriasis and/or active AD/eczema.
    Subjects who have a history of AD.
    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.
    Known sensitivity to any of the components of the investigational products.
    History of the rash to the adhesive plaster, contact dermatitis to metal, or cosmetic
    and household articles.
    Cohort 2
    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.
    Has unstable AD or a consistent requirement for strong to strongest potency topical
    corticosteroids to manage AD signs and symptoms.
    Has a significant active systemic or localized infection, including known actively
    infected AD.
    Has a history or evidence of clinically significant or severe allergies (eg, seasonal,
    pet dander, environmental, food) requiring acute or chronic treatment.
    Has recent or anticipated concomitant use of topical or systemic therapies that might
    alter the course of AD.
    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]).
    Has a known sensitivity to any of the components of crisaborole ointment 2%.
    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.

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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