Title

CO125 Efficacy of Clascoterone Cream 1% for up to 12 Months in Patients ≥9 Years of Age with Acne vulgaris: Results from a Long-Term Extension Study

Authors

Lawrence F. Eichenfield
Adeaide A. Hebert
Linda F. Stein Gold, Henry Ford HealthFollow
Martina Cartwright
L. Moro
J. Han
Nicholas Squittieri
A. Mazzetti

Recommended Citation

Eichenfield LF, Hebert AA, Stein Gold L, Cartwright M, Moro L, Han J, Squittieri N, and Mazzetti A. CO125 Efficacy of Clascoterone Cream 1% for up to 12 Months in Patients ≥9 Years of Age with Acne vulgaris: Results from a Long-Term Extension Study. Value Health 2023; 26(6):S38.

Document Type

Conference Proceeding

Publication Date

6-1-2023

Publication Title

Value Health

Abstract

Objectives: Clascoterone cream 1% is approved for the treatment of acne vulgaris in patients aged ≥12 years. Efficacy data from an open-label extension study are presented.

Methods: The open-label, multicenter extension study (CB-03-01/27) enrolled male and female patients aged ≥9 years who completed one of the 12-week Phase 3 trials (CB-03-01/25 and CB-03-01/26) in patients with moderate-to-severe acne vulgaris. All patients applied 1% clascoterone cream twice daily to the face for 9 months; in the extension study, patients with truncal acne could also treat affected areas of the shoulders, chest, and/or back. Total time on clascoterone was up to 12 months for patients originally randomized to clascoterone in the Phase 3 trials. A 5-point Investigator’s Global Assessment (IGA; 0, clear; 4, severe) was performed at extension Days 29, 85, 183, and 274; clascoterone treatment could be discontinued if IGA was 0 or 1 (IGA 0/1) and reinstated if/when acne worsened. Efficacy was analyzed in the intention-to-treat (ITT) population.

Results: The ITT population included 609 patients, of whom 251 patients were treated for truncal acne. At baseline/Day 29/85/183/274, the proportion of ITT patients achieving facial IGA 0/1 was 9.9%/8.5%/10.1%/17.3%/29.8% and the proportion of ITT patients achieving truncal IGA 0/1 was 4.8%/17.1%/20.7%/25.9%/31.5%. In the ITT population, 539/417/304/123 patients used clascoterone for a total of 3/6/9/12 months. By total time on clascoterone, 13.1%/18.9%/39.2%/56.1% of ITT patients achieved facial IGA 0/1 and 13.6%/37.6%/43.4%/59.2% of ITT patients achieved truncal IGA 0/1 after 3/6/9/12 months on clascoterone treatment.

Conclusions: Clascoterone cream 1% maintained a favorable efficacy profile for up to 12 months in patients aged ≥9 years with acne vulgaris.

Volume

26

Issue

6

First Page

S38