Winlevi a.k.a clascoterone marks the first new acne medication to be approved since Accutane in 1982.
While we have yet to find the ultimate cure-all for acne, we can now look forward to a clearer future with the latest development in acne medication. The Food and Drug Administration (FDA) recently approved a new topical cream called Winlevi, that could replace the off-label use of spironolactone pills – which has been known to be used as medication for treating hormonal acne. This new breakthrough marks the first new acne medication to be approved since the popular Accutane a.k.a isotretinoin in 1982.
While we’re more familiar with acne treatments and medications such as antibiotics, clindamycin, salicylic acid, benzoyl peroxide, adapalene, retinoids, and azelaic acid to control acne, Winlevi introduces a new active: 1% clascoterone. It’s to be used as a topical androgen receptor inhibitor, meaning it inhibits testosterone and dihydrotestosterone (DHT) when applied to the skin. This ingredient can also be used for the treatment of hair loss on the scalp such as alopecia.
A common cause for blemishes is sebum overproduction, which androgens in your skin are responsible for. This can lead to bacterial infection, inflammation, and the exacerbation of acne. Cassiopea, the pharmaceutical company behind Winlevi, states that while the exact mechanism behind how clascoterone works in currently unknown, the treatment cream was proven to reduce acne lesions in clinical trials in both men and women over the age of 12.
A breakthrough in acne medication
What makes clascoterone such a groundbreaking development though? Simply put, it’s the first androgen blocker for acne that can be taken by both women and men. In order to reduce androgen activity and control acne breakouts – especially hormonal ones, women are often prescribed birth control pills and spironolactone. However, a 2020 study in JAMA Dermatology points out that clascoterone is ultimately a safer and more effective drug for controlling acne: “Both birth control and spironolactone are associated with systemic adverse effects, are contraindicated in pregnancy, and are unsuitable for use in males with acne.” Spironolactone is also not usually prescribed for the treatment of androgen-dependent acne because of its feminising side effects such as breast development. The study shows that not only is clascoterone safe and effective for both women and men, it can also be used as an adjunct treatment alongside other common acne medications such as 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,” says dermatologist Michael Gold, an Investigator and Medical Director at Gold Skin Care Center and Tennessee Clinical Research Center in a press release. “After 40 years, it provides a much-anticipated, complementary new approach to treat acne.”
Based on clinical trials where the topical cream was applied twice a day, acne lesions were shown to be reduced. Skin redness and dryness were noted down as side effects, which are common when it comes to using topical acne treatments. “This milestone approval marks the introduction of a new class of topical medication in dermatology,” says Diana Harbort, the CEO of Cassiopea. “Dermatologists have said targeting androgen hormonal activity in the skin is ‘the holy grail’ of acne treatment for both males and females.”
As exciting as this news is for acne-sufferers, we can only wait in anticipation, as Winlevi (clascoterone) will be first made available in the U.S. in 2021.
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