The FDA Just Approved Winlevi, a New Topical Treatment for Acne

Early next year, dermatologists could have an exciting new acne drug to add to their arsenal of treatment options. Winlevi is a first-of-its-kind topical cream that was officially approved at the end of August by the United States Food and Drug Administration (FDA) for use in patients 12 years and older. The acne treatment is expected to be available at the beginning of 2021.

"Other commonly used acne medications include topical antibiotics and topical retinoids, but Winlevi, also called Clascoterone Cream 1%, is different in that it is the only topical medication that targets the androgen receptors in the skin," says board-certified dermatologist and founder of Eternal Dermatology, Ife Rodney. "The result is less sebum production and oil buildup."

Androgens are hormones that are responsible for driving sebum production and inflammation — both of which are leading causes of acne. According to a press release from Cassiopea, the pharmaceutical company behind the development of Winlevi, the drug's active ingredient, clascoterone, "acts by limiting the effects of these hormones," which thereby leads to fewer breakouts.

In clinical trials conducted by Cassiopea, Winlevi demonstrated a reduction in acne lesions and was well-tolerated when applied to the skin twice a day. The most common side effect, which occurred in 7 to 12 percent of patients, was mild erythema — aka reddening of the skin. (Other potential side effects include burning, itching, and peeling.)

"As with other topical acne medications, [Winlevi] may cause redness, dryness, and irritation of the skin," confirms Rodney. "You should also be careful to not apply it to very large areas of the skin or for long periods of time, as this may increase the risk of internal side effects, like hormonal imbalance."

New York City-based board-certified dermatologist Shari Marchbein tells Allure she's excited to try Winlevi and add it to her treatment armamentarium. That being said, she doesn't believe it'll be a complete cure-all.

"I feel it will work best as an additional treatment option in a comprehensive routine but, not necessarily as monotherapy," she says. "I also do not feel this will substitute for oral medications that mediate hormones, like Spironolactone."

Needless to say, this is definitely promising news for skin-care experts and those with acne alike.

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Originally Appeared on Allure