Winlevi (clascoterone) is a prescription cream that treats acne by blocking the hormonal activity that drives breakouts directly at the skin’s surface. It’s the first topical anti-androgen approved for acne, meaning it targets one of acne’s root causes, excess hormone stimulation of oil glands, without the systemic side effects of oral hormone-blocking medications. It’s applied twice daily and is approved for patients 12 years and older.
How Winlevi Works on Your Skin
Your skin’s oil glands have receptors that respond to a hormone called dihydrotestosterone (DHT). When DHT binds to these receptors, it triggers two things that lead to acne: increased oil production and inflammation. Winlevi’s active ingredient, clascoterone, competes with DHT for those same receptors. When clascoterone gets there first, DHT can’t latch on, so the oil glands produce less sebum and the surrounding skin generates fewer inflammatory signals.
What makes this approach notable is that it all happens locally. Once clascoterone absorbs into your skin, enzymes quickly break it down into an inactive compound that your body already produces naturally. This rapid breakdown is why Winlevi doesn’t cause the hormonal side effects associated with oral anti-androgen drugs like spironolactone, which work throughout the entire body and can affect potassium levels, blood pressure, and menstrual cycles. Winlevi also works for both men and women, while oral spironolactone is typically only prescribed to women due to its systemic hormonal effects.
What to Expect From Treatment
In the two large Phase 3 clinical trials, about 18 to 20% of patients using Winlevi achieved clear or almost-clear skin after 12 weeks, compared to 6.5 to 9% of patients using the vehicle cream (the same cream without the active ingredient). Those numbers might seem modest at first glance, but the trials measured a strict standard: patients needed both a two-grade improvement on a clinical scale and meaningfully fewer pimples and clogged pores. Winlevi also reduced both inflammatory lesions (red, swollen pimples) and non-inflammatory lesions (blackheads and whiteheads).
Don’t expect fast results. Like most topical acne treatments, Winlevi takes time. Clinicians generally assess whether it’s working at the 3-month mark, and some dermatologists wait 4 to 6 months before deciding if the treatment is effective for a given patient. If you’re not seeing improvement after a couple of weeks, that’s completely normal and not a reason to stop.
How to Apply It
The routine is straightforward: wash the affected area gently, let your skin dry, then apply a thin layer (roughly 1 gram, about the size of a large pea for the face) to the breakout-prone areas. You do this twice a day, once in the morning and once in the evening. It fits into a standard skincare routine before moisturizer or sunscreen.
Storage is worth knowing about because it’s unusual. Your pharmacist stores Winlevi in a refrigerator before dispensing it, but once you take it home, you keep it at room temperature (between 68°F and 77°F). You need to discard any unused cream one month after first opening the tube, or 180 days after it was dispensed, whichever comes first. Don’t freeze it.
Side Effects
The most common reactions are local and relatively mild. In clinical trials, about 12% of patients experienced redness at the application site, roughly 10% had scaling or dryness, and about 8% reported itching. Stinging or burning affected around 4% of users, and mild swelling occurred in about 3.6%. These rates were measured over 12 weeks of twice-daily use.
Less common skin reactions included stretch marks (2.5%), skin thinning (1.6%), and visible tiny blood vessels called telangiectasia (1.2%). Because clascoterone is structurally related to cortisol, there’s a theoretical concern about suppressing your body’s natural cortisol production. In a dedicated safety study, a small number of adults (1 out of 20) and adolescents (2 out of 22) showed signs of this suppression after two weeks of use, but all returned to normal within four weeks of stopping treatment. Younger patients may be more susceptible to this effect, which is one reason dermatologists monitor adolescents more closely.
How Winlevi Compares to Oral Anti-Androgens
Spironolactone, the most commonly prescribed oral anti-androgen for acne, blocks the same type of hormone receptors but does so throughout the body. At higher doses (200 mg), spironolactone produces a larger overall reduction in acne lesions than Winlevi. However, that systemic reach comes with trade-offs: spironolactone can cause dizziness, breast tenderness, irregular periods, and requires periodic blood work to monitor potassium levels. It’s also only used in women because of its feminizing hormonal effects.
Winlevi fills a gap for patients who want to address hormonal acne topically, who can’t tolerate oral medications, or who aren’t candidates for spironolactone (including men and younger adolescents). Some dermatologists also use it alongside other topical treatments like retinoids or benzoyl peroxide, since it works through a completely different mechanism than those products.