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Safety, effectiveness, and pharmacokinetics of crisaborole in infants aged 3 to < 24 months with mild-to-moderate atopic dermatitis: A phase IV open-label study (CrisADe CARE 1)

American Journal of Clinical Dermatology Mar 27, 2020

Schlessinger J, Shepard JS, Gower R, et al. - In this open-label study, researchers tested the safety, effectiveness, and pharmacokinetics (PK) of crisaborole in infants aged 3 to < 24 months with mild-to-moderate atopic dermatitis (AD), a chronic, highly pruritic, inflammatory skin disease. Participants in the study were 137 infants total (mean age [SD], 13.6 months [6.42]), with 21 in the pharmacokinetics cohort. Specifically, ‘application site pain’ and ‘application site discomfort’ have been reported at rates comparable to those seen in crisaborole studies in patients aged ≥ 2 years, and no new safety signals have been identified. According to findings, crisaborole was effective and well tolerated in infants (3 to < 24 months) with mild-to-moderate AD with systemic exposures comparable to patients aged ≥ 2 years.

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