Crisaborole 2% ointment is used for the topical treatment of mild to moderate atopic dermatitis (eczema) in adults and children 2 years of age and older.
Efficacy and safety of crisaborole 2% ointment for the topical treatment of atopic dermatitis were established in 2 identical, randomized, double-blind, vehicle-controlled, multicenter phase 3 studies that included 1522 individuals 2-79 years of age (about 86% were 2-17 years of age) who had mild to moderate atopic dermatitis (as defined by the Investigator's Static Global Assessment [ISGA] score) involving 5-95% of body surface area. According to ISGA scoring (severity scale of 0-4 based on erythema, induration/papulation, and oozing/crusting), 39% of study patients had an ISGA score of 2 (mild) and 62% had a score of 3 (moderate). Patients were randomized to receive crisaborole 2% ointment or vehicle applied to atopic dermatitis lesions twice daily for 28 days. The primary efficacy end point in both studies was the proportion of patients achieving a successful ISGA score on day 29, defined as an ISGA score of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline. A successful ISGA score was achieved on day 29 in 31 and 33% of patients treated with crisaborole 2% ointment compared with 18 and 25% of those treated with vehicle control. A greater proportion of crisaborole-treated patients had clinical improvement in signs and symptoms of atopic dermatitis (e.g., pruritus, erythema, exudation, excoriation, induration/papulation, lichenification) than placebo-treated patients. Beneficial effects were evident as early as 8 days after topical crisaborole treatment was initiated.