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This study examines the effect of Crisaborole 2% ointment on skin biomarkers, compared with placebo, in patients with atopic dermatitis. It was designed for patients with mild to moderate atopic dermatitis. The study was conducted in Phase 2 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Confirmed diagnosis of active atopic dermatitis (AD) with at least 6 month history prior to Screening and that has been clinically stable for 1 month. * Investigator's Static Global Assessment (ISGA) of 2 (mild) or 3 (moderate) at Baseline. * Body surface area (BSA) covered with AD of at least 0.5% and no more than 10% at Baseline, calculation excluding face, scalp, axilla, genitals, groin area, palms, back of the hands, and soles. * Two lesions of AD at least 3 cm x 3 cm in size and at least 5 cm apart, with identical Lesion ISGA score of greater than/equal to 3. Exclusion Criteria: * Clinically infected AD or requires high potency topical corticosteroids or systemic (oral/injectable) corticosteroids to manage AD. * History of angioedema or anaphylaxis to topical products or known sensitivity to components of crisaborole ointment 2%. * History of cancer (except squamous or basal cell carcinoma or carcinoma in situ of the skin). * Previous treatment with any topical or systemic PDE4 inhibitor unless stopped for the reason of lack of efficacy.