Crisaborole ointment, 2%, was well tolerated in this open-label study of infants aged 3 to <24 months with mild-to-moderate AD. Application site pain/discomfort was reported at a rate similar to those in crisaborole studies of patients aged ≥2 years; no new safety signals were identified.

Improvements from baseline in exploratory efficacy endpoints (including Investigator’s Static Global Assessment, Eczema Area and Severity Index, percentage of treatable body surface area, and Patient-Oriented Eczema Measure outcomes) were observed at the first postbaseline assessment (day 8 or 15, depending on outcome measure) and continued through the end of treatment (day 29).

Based on nonlinear regression analysis accounting for dose and age differences, crisaborole systemic exposure in infants aged 3 to <24 months was comparable with that observed in crisaborole studies of patients aged ≥2 years.