A Study of Crisaborole Ointment 2% in Children Aged 3-24 Months With Mild to Moderate Atopic Dermatitis

Summary

This 4-week study will evaluate the safety, pharmacokinetics (PK), and efficacy of crisaborole ointment 2%, applied twice daily (BID) in subjects who are 3 months to less than 24 months of age with mild-to-moderate AD.

Timeline

Start

2018-01-16

Primary completion

2019-04-12

Completion

2019-04-12

Publications

• Schlessinger J, Shepard JS, Gower R, Su JC, Lynde C, Cha A, Ports WC, Purohit V, Takiya L, Werth JL, Zang C, Vlahos B; CARE 1 Investigators. 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). Am J Clin Dermatol. 2020 Apr;21(2):275-284. doi: 10.1007/s40257-020-00510-6.

Drugs

Indications