Winlevi Is the First FDA-Approved Acne Drug Since Accutane, Here’s What You Need to Know

Winlevi, or clascoterone cream 1%, is a new acne-fighting topical medication that was FDA-approved in August 2020 for use in 2021 for the treatment of acne vulgaris. It’s the first acne drug with a new mechanism of action that’s been approved by the FDA since 1982. “Winlevi is a topical drug that offers a non-antibiotic option that targets the androgen receptor directly in the skin,” explains Corey L. Hartman, MD, a board-certified dermatologist and founder of Skin Wellness Dermatology in Birmingham, Ala. “The generic name is clascoterone and it is offered as a cream that inhibits the effects of hormones on oil production and inflammation. Though acne is multifactorial, increased sebum production and an altered lipid composition is thought to promote inflammation.”

Previously, the only way to control oil production was through oral medications like spironolactone or isotretinoin (formerly known as Accutane). “Winlevi is a first-in-class molecule thought to inhibit sebocyte activity when applied topically,” explains Dr. Hartman.

What’s so incredible about Winlevi is that it can be used on both women and men. Before Winlevi, “we only [had] oral medications, such as combined oral contraceptives and spironolactone, to address the hormonal component of acne,” explains Shari Marchbein, MD, a board-certified dermatologist and the clinical assistant professor of dermatology at NYU School of Medicine. “Additionally, those aforementioned medications can only be used in women, so [Winlevi] is a promising adjuvant treatment for men as well as women who don’t want to take oral medications.” Winlevi is indicated for people ages 12 and older with moderate to severe acne, and it has shown efficacy in clinical trials to treat both inflammatory and non-inflammatory acne lesions.

Unlike other topical medications and ingredients typically used to treat acne (think retinol, salicylic acid, and benzoyl peroxide), Winlevi targets hormones (specifically androgens) on the skin to help clear up hormonal acne. Winlevi “is the first topical anti-hormonal treatment for acne (topical spironolactone has been studied previously and really does not work well as an acne treatment),” explains Dr. Marchbein. “While we use birth control pills and spironolactone orally, we do not have good topicals to address androgens in the skin—I am excited to try this and add it to my treatment armamentarium.”

According to Dr. Hartman, side effects in the studies were minimal and consisted of local skin reactions rated as mild—the reactions were also seen in the control group as well. “The most common side effects are localized redness, burning, and irritation, which are almost universally common with topical acne treatments especially retinoids,” says Dr. Marchbein. “When starting a new acne routine, I typically recommend starting to use three times weekly and increasing as tolerated and moisturizing the skin well twice daily.”

“It is possible that topical Winlevi will be an alternative for oral medications that target the sebaceous glands like Accutane and spironolactone, but there are no head-to-head studies to compare it to, either,” explains Dr. Hartman.

While it might be possible, Dr. Marchbein sees Winlevi as being more of an additional step or treatment option in a comprehensive routine, rather than as monotherapy for hormonal acne. Winlevi “can be used as a first-line or as an addition for those that haven’t cleared [their acne] with more conventional treatment,” explains Dr. Marchbein. “I would not use this as monotherapy, but no acne treatments are typically sufficient as monotherapy (with lesional clearance rates around 30 percent for most topical acne medications).”

For her patients struggling with acne, Dr. Marchbein is excited to recommend layering Winlevi with other topicals, including retinoids, and use it in conjunction with birth control pills and spironolactone. “What will be most interesting is to see if either oral anti-hormonal therapies (like spironolactone) and hormonal therapies (like birth control pills), which bind to androgens in the skin/oil glands and blood, respectively, can be used at lower doses or potentially not at all, with the addition of Winlevi to the treatment routine,” explains Dr. Marchbein. “I also do not feel this will substitute for oral medications that mediate hormones like oral contraceptive pills and spironolactone, but we won’t know until we as dermatologists start incorporating it into acne routines.”

“In the studies, Winlevi was used as monotherapy to establish safety and efficacy, but there is no reason to believe that it can’t be used as part of a regimen in combination with other active ingredients,” explains Dr. Hartman. “We will certainly learn more as the drug is released and used in clinical practice.”

Dr. Marchbein backs this claim and explains that there are very few studies (during the FDA-approval process) that actually show efficacy when one topical acne medication is used in combination with another. “That being said, because acne is multifactorial, treatment routines often consist of combinations of two to four topicals that work via different mechanisms, in addition to birth control pills and spironolactone for women, occasionally oral antibiotics, and even isotretinoin,” says Dr. Marchbein. “Most patients require a combination of prescription creams including retinoids (the backbone of any acne routine) as well as benzoyl peroxide, topical dapsone, and topical antibiotics, and I anticipate adding Winlevi to this group.”