If you're one of the millions of people suffering from acne—still, after years of trialing different creams, potions, cleansers, and pills—there is hope on the horizon. The Food and Drug Administration (FDA) just approved a new drug called Winlevi, and it could replace the popular off-label use of spironolactone. It's the first new acne medication to be approved since Accutane (isotretinoin) way back in 1982.
So how does it work, and what makes it so groundbreaking? The acne medications currently on the market rely on antibiotics, benzoyl peroxide, salicylic acid, azelaic acid, dapsone, and vitamin A derivatives known as retinoids to quell acne. Winlevi is the first to use a totally new active: 1% clascoterone. Clascoterone is a topical androgen receptor inhibitor, meaning it inhibits testosterone and dihydrotestosterone (DHT) when applied to skin. The ingredient is also used for the treatment of hair loss on the scalp.
Androgens in your skin are responsible for the production of sebum (oil) and can lead to inflammation, which exacerbates acne. Cassiopea, the pharmaceutical company behind Winlevi, notes that while the exact mechanism behind how clascoterone works is unknown, the cream was proven to work in clinical trials in both men and women over the age of 12.
What makes clascoterone such a breakthrough is that it's the first androgen blocker for acne that works in both men and women. Women are often prescribed birth control and spironolactone (off-label) to reduce androgen activity and help with acne breakouts. But as a 2020 study in JAMA Dermatology points out: "Both [birth control] and spironolactone are associated with systemic adverse effects, are contraindicated in pregnancy, and are unsuitable for use in males with acne." The study concludes that not only is clascoterone safe and effective for both women and women, but it can also be used as an adjunct treatment with other acne medications like retinoids.
“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,” notes dermatologist Michael Gold, an Investigator and Medical Director at Gold Skin Care Center and Tennessee Clinical Research Center, in the press release. “After 40 years, it provides a much-anticipated, complementary new approach to treat acne.”
The clinical trials showed a reduction in acne lesions when used twice a day, and the most common side effects were reddening of the skin and dryness. “This milestone approval marks the introduction of a new class of topical medication in Dermatology," Diana Harbort, CEO of Cassiopea, notes in the press release. "Dermatologists have said targeting androgen hormonal activity in the skin is ‘the holy grail’ of acne treatment for both males and females."
Don't call your dermatologist just yet. Winlevi will be available in the U.S. starting next year.
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