Clascoterone Cream 1% for the Treatment of Acne

On August 27, 2020, the 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 2 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 2 trials were identically designed, double-blind, placebo-controlled studies enrolling a total of 1440 patients 9 years or older. Treatment success was defined as an Investigator’s Global Assessment 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) vs 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.” said Michael Gold, MD, 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

Christine Pham, PharmD, is a PGY-1 pharmacy resident at East Jefferson General Hospital.

References

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-first-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