We Asked 4 Derms About Winlevi, the Newest FDA-Approved Acne Drug

It's a game-changer.

woman with acne

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According to the American Academy of Dermatology, acne is the most common skin condition in the U.S. and affects up to 50 million Americans annually. There are several methods of treating acne, from cleansers to OTC medication. Accutane, Spironolactone, and tetracycline antibiotics have long been the most common systemic prescriptions for acne. But for the first time since 1982 (when Accutane was approved), the Food and Drug Administration (FDA) just signed off on an acne medication with a new mechanism of action. Enter: Winlevi, a cream-based treatment by Cassiopea.

To find out how Winlevi works and why this cream is a gamechanger for people with acne-prone skin, we asked four dermatologists to share their thoughts.

Meet the Expert

  • Dr. Morgan Rabach is a board-certified dermatologist and co-founder of LM Medical PLLC.
  • Dr. Rachel Nazarian is a board-certified dermatologist and assistant clinical professor at Mount Sinai Hospital Department of Dermatology.
  • Dr. Mona Gohara is a board-certified dermatologist and vice president of the Women's Dermatologic Society.
  • Dr. Corey L. Hartman is a board-certified dermatologist and founder of Skin Wellness Dermatology.

What Is Hormonal Acne?

It's important to know what differentiates hormonal acne from other forms. "Hormonal acne is caused by hormonal fluctuations," Dr. Hartman says. "The production of testosterone rises during puberty, which leads to increased production in sebum. The increased sebum either clogs pores or mixes with acne bacteria, leading to an increase in acne (often on the face). This same cycle can also occur with adult women following their menstrual cycle. Just before menstruation begins, estrogen and progesterone levels drop, which also causes an increase in sebum production."

While we might think hormonal acne only occurs in teens and young adults, Dr. Hartman said that's not the case. "Often hormonal acne doesn't start until after the age of 30 and can last for years, through adulthood and even menopause," he explains.

What Is Winlevi?

Winlevi, also known as clascoterone, is a topical medication approved by the FDA for use in 2021 to treat acne vulgaris. "It's the first anti-androgen receptor topical cream," Dr. Rabach says. Androgens cause increased sebum production, which leads to clogged pores which leads to acne. This medication would block this."

In clinical trials, Winlevi has appeared to demonstrate a favorable safety profile and improvement in efficacy for acne treatment. Less than 2% of patients experienced systemic side effects during testing.

Why Is It Different?

Winlevi is unique because it is a topical treatment as opposed to an oral medication like Accutane and Spironolactone. “It doesn’t seem to have interactions with other oral medications like Spironolactone and Accutane do,” Dr. Rabach added. 

Who Should Use Winlevi?

Dr. Gohara says Winlevi is recommended for people who have acne, particularly in a hormonal distribution. The cream has been approved to treat acne vulgaris in people 12 and older and must be prescribed by a board-certified dermatologist.

Dr. Gohana says Winlevi is also a suitable option for "those who have tried other topicals such as retinoids or BHA's, without success, or those who do not want to go on oral medication such as antibiotics." 

Dr. Nazarian also notes the medication’s introduction to the market is great news for men. “It offers another useful option for male patients suffering from acne since these patients cannot use Spironolactone,” she tells us.

How to Use Winlevi

For best results, you should apply Winlevi directly to the affected areas on your face. "The directions say to apply the medication on the nodules and then rub it into the surrounding skin as well," Dr. Hartman says. "It is not a spot treatment, but I refer to it as spot intensive."

Dr. Hartman says you'll need to consistently use Winlevi to see results. "Winlevi is meant to be used on a long-term basis as acne is a chronic condition that requires ongoing management," he notes.

What Are The Side Effects?

During the clinical trial phase of Winlevi, a few possible side effects were discovered. Dr. Rabach noted people may experience local irritation including pruritus, burning, skin redness, or peeling. She says Winlevi may also cause hypothalamic-pituitary-adrenal suppression in certain patients, meaning this medication may affect the hormone balance in your body. 

Will It Replace Accutane and Spironolactone?

While Winlevi is projected to be a groundbreaking treatment, experts don't expect the medication to completely eradicate the need for Accutane and Spironolactone. "Accutane has the additional benefit of offering a potential lifelong cure for acne, and also may help with scarring, blackheads, and whiteheads," Dr. Nazarian says. "Spironolactone also offers additional benefits since it is an oral medication, and can help with decreasing oil production and improving hair which many people appreciate. For body acne or severe acne, a topical choice is often not appropriate."

Final Thoughts

Winlevi is a potential game-changer for anyone who deals with hormonal acne and is open to utilizing a topical medication to manage it. According to clinical trials, it has proven to be safe and effective at combating hormonal acne in individuals 12 and older. If you’ve experienced adverse reactions to other acne prescriptions, Winlevi is worth a try. 

Article Sources
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  2. Hebert A, Thiboutot D, Stein Gold L, et al. Efficacy and safety of topical clascoterone cream, 1%, for treatment in patients with facial acne. JAMA Dermatol. 2020;156(6):1-10.

  3. Layton A. The use of isotretinoin in acne. Dermatoendocrinol. 2009;1(3):162-169.

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