A Study to Evaluate Long-Term Maintenance Treatment With Once Daily Crisaborole Ointment 2% in Pediatric and Adult Participants With Mild-to-Moderate Atopic Dermatitis

Summary

This study will evaluate crisaborole therapy once daily (QD) as a long-term topical maintenance therapy for the reduction of flare in responders to crisaborole twice daily (BID) treatment.

Timeline

Start

2019-09-12

Primary completion

2022-01-19

Completion

2022-01-19

Outcome

Met primary endpoint

paper Median time of flare-free maintenance was longer for patients who received crisaborole versus vehicle (111 vs 30 days, respectively; p = 0.0034). PMID 37184828 ↗

Publications

• Eichenfield LF, Stein Gold LF, Lynde C, Guenther L, Greenberger S, Chu CY, Ghodsi Z, Vlahos B, Sanders P, Cha A, Canosa JM. Maintenance of Investigator's Static Global Assessment Response with Once-Daily Crisaborole in Participants with Mild to Moderate Atopic Dermatitis. Dermatol Ther (Heidelb). 2024 Apr;14(4):875-892. doi: 10.1007/s13555-024-01129-9. Epub 2024 Mar 28.
• Eichenfield LF, Gower RG, Xu J, Alam MS, Su JC, Myers DE, Sanders P, Vlahos B, Zang C, Lan J, Werth J. Once-Daily Crisaborole Ointment, 2%, as a Long-Term Maintenance Treatment in Patients Aged >/= 3 Months with Mild-to-Moderate Atopic Dermatitis: A 52-Week Clinical Study. Am J Clin Dermatol. 2023 Jul;24(4):623-635. doi: 10.1007/s40257-023-00780-w. Epub 2023 May 15.

Drugs

Indications