In 1982, the FDA approved isotretinoin (Accutane), a Vitamin A derivative, for use in patients with acne. No new methods of acne medication had been approved from 1982 until the approval of topical clascoterone in August 2020, almost 40 years later.
Topical clascoterone is a cream that is applied directly to the skin of areas affected by acne. Clascoterone is an antiandrogen, which is a class of drug that blocks androgen receptors. The drug is the first antiandrogen to be approved by the FDA for acne medication, earning it the title of first-in-class medication. Androgens, which are male sex hormones present in males and lower levels in females, play an important role in the pathogenesis of acne.
During puberty, both males and females have increased levels of androgens like testosterone or dihydrotestosterone (DHT). Higher levels of testosterone can cause increased production of sebum, an oily substance secreted by sebaceous glands under the skin. Excessive amounts of sebum in a skin pore can cause a blockage (known as a comedo, blackhead, or whitehead) that may become infected.
Clascoterone was shown in vitro to have higher affinity for androgen receptors than DHT. This blockage of local androgen receptors by clascoterone was then shown by clinical trials to reduce the acne-causing effects of androgens.
The Investigator’s Global Assessment Scale (IGA) is a scale of acne severity that goes from 0 (clear) up to 4 (severe). Two clinical trials found that at least 18% of patients achieved a drop of at least 2 points on the IGA scale (resulting in a score of 0 or 1) at 12 weeks into treatment with topical clascoterone. One trial showed that patients, on average, saw a 39% decrease in total lesion count after 12 weeks of treatment.
The FDA listed the most common side effects of topical clascoterone as reddening, itching, and scaling or dryness of treated skin. The FDA-approved brand of topical clascoterone is Winlevi.
- Piszczatoski, C. (2021, October 2). Topical Clascoterone: The First Novel Agent for Acne Vulgaris in 40 Years. https://doi.org/10.1016/j.clinthera.2021.08.007
- U.S. Food and Drug Administration. (2020, September 3). Drug trial snapshot: Winlevi. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trial-snapshot-winlevi