A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (25)

Summary

The primary objective of this study is to determine the safety and efficacy of CB-03-01 cream, 1%, versus the vehicle cream applied twice daily for 12 weeks in subjects with facial acne vulgaris.

Timeline

Start

2016-01-21

Primary completion

2018-04-11

Completion

2018-04-11

Outcome

Met primary endpoint

paper P < .001) vs 9.0% and 6.5% with vehicle, respectively. PMID 32320027 ↗

Publications

• Hebert A, Eichenfield L, Thiboutot D, Stein Gold L, Vassileva S, Mihaylova Y, Cartwright M, Moro L, Fragasso E, Han J, Squittieri N, Mazzetti A. Efficacy and Safety of 1% Clascoterone Cream in Patients Aged > 12 Years With Acne Vulgaris. J Drugs Dermatol. 2023 Feb 1;22(2):174-181. doi: 10.36849/JDD.7000.
• Piszczatoski CR, Powell J. Topical Clascoterone: The First Novel Agent for Acne Vulgaris in 40 Years. Clin Ther. 2021 Oct;43(10):1638-1644. doi: 10.1016/j.clinthera.2021.08.007. Epub 2021 Oct 2.
• Hebert A, Thiboutot D, Stein Gold L, Cartwright M, Gerloni M, Fragasso E, Mazzetti A. Efficacy and Safety of Topical Clascoterone Cream, 1%, for Treatment in Patients With Facial Acne: Two Phase 3 Randomized Clinical Trials. JAMA Dermatol. 2020 Jun 1;156(6):621-630. doi: 10.1001/jamadermatol.2020.0465.

Drugs

Indications