The topical cream is the first acne drug with a new mechanism of action to win FDA approval in the last 40 years.
On August 27, 2020, the U.S. FDA approved clascoterone 1% cream (Winlevi; Cassiopea) for the treatment of acne in patients 12 years and older.1
Clascoterone cream 1% is a first-in-class topical acne treatment that targets the androgen receptors in the skin. The last FDA approval of an acne drug with a new mechanism of action occurred nearly 40 years ago.1
Clascoterone cream is applied as a thin layer to the affected areas twice daily; avoiding contact with eyes, mouth, and mucous membranes.
The approval is based on data from two clinical trials (CB-03-01/25 and CB-03-01/26), in which clascoterone cream 1% demonstrated a reduction in acne lesions after 12 weeks of treatment. The two trials were identically designed, double-blind, placebo-controlled studies enrolling a total of 1,440 patients nine years or older. Treatment success was defined as an Investigator’s Global Assessment (IGA) score of 0 or 1, and a 2-grade or greater improvement from baseline and absolute change from baseline in noninflammatory and inflammatory lesion counts at week 12.2
At week 12, treatment success rates in CB-03- 01/25 and CB-03-01/26 with clascoterone cream 1% were 18.4% (point estimate, 2.3; 95% CI, 1.4- 3.8; P < .001) and 20.3% (point estimate, 3.7; 95% CI, 2.2-6.3; P < .001) versus 9.0% and 6.5% with placebo, respectively. At week 12, in both CB-03-01/25 and CB-03-01/26, treatment with clascoterone cream 1% resulted in a significant reduction in absolute noninflammatory lesions from baseline to −19.4, as well as a reduction in inflammatory lesions from baseline to −19.3 and −20.0, respectively.2
Overall, clascoterone cream 1% was well tolerated and demonstrated similar safety profile to placebo. The most common adverse events in studies were nasopharyngitis, headache and oropharyngeal pain.2
“The approval of Winlevi is an exciting breakthrough in acne treatment. This game-changing topical drug offers a non-antibiotic approach to people with acne, by targeting the androgen receptors directly in the skin. It fills a longstanding gap in acne therapy,” says Michael Gold, M.D., investigator and medical director, Gold Skin Care Center and Tennessee Clinical Research Center. “After 40 years, it provides a much-anticipated, complementary new approach to treat acne.”1
According to Cassiopea, clascoterone cream 1% is expected to be available early 2021.1
1. Cassiopea receives FDA approval for Winlevi® (clascoterone cream 1%), first in-class topical acne treatment targeting the androgen receptor. Press release. Cassiopea; August 27, 2020. Accessed September 29, 2020. https://www.cassiopea.com/2020/08/27/cassiopea-receives-fda-approval-for-winlevi-clascoterone-cream-1-fi rst-in-class-topical-acne-treatment-targeting-the-androgen-receptor/
2. Hebert A, Thiboutot D, Stein Gold L, et al. efficacy and safety of topical clascoterone cream, 1%, for treatment in patients with facial acne: two phase 3 randomized clinical trials. JAMA Dermatol. 2020;156(6):621-630. doi:10.1001/ jamadermatol.2020.0465