Clascoterone (Winlevi) for Acne: How It Works and Trial Results

Clascoterone 1% cream (brand name Winlevi) is a prescription acne cream that blocks androgen hormones at the skin, the first topical treatment to work this way. In two large 12-week trials it roughly doubled the chance of clear or almost-clear skin compared with an inactive cream, although only about one in five people reached that point. It is approved from age 12, is applied twice a day, and is usually well tolerated, but cost and access are real hurdles.

What is clascoterone (Winlevi)?

Androgens, such as testosterone and its more potent cousin dihydrotestosterone (DHT), drive oil gland activity, and oil is one of the core ingredients of acne. Until recently, the only way to target that hormonal pathway was with pills such as spironolactone or combined birth control, which work throughout the body. Clascoterone is designed to do a version of this locally.

The FDA prescribing information describes clascoterone as an androgen receptor inhibitor, while being candid that exactly how it improves acne “is unknown.” In lab experiments on human oil-gland cells, clascoterone bound the androgen receptor with high affinity and reduced androgen-driven production of oil lipids and inflammatory signaling molecules. The same lab work found it was better than spironolactone at inhibiting those inflammatory molecules, but that is a cell-culture finding, not evidence that the cream outperforms spironolactone tablets in people.

The FDA approved it on August 26, 2020, and it launched in the US in November 2021, described at the time as the first acne drug with a new mechanism of action in nearly four decades. Outside the US, DermNet lists approvals in Canada (2023), Australia and New Zealand (2024) and the UK (2025). In Europe, the European Medicines Agency initially recommended refusing approval over safety concerns, then recommended approval after a re-examination in August 2025, and the companies announced European Commission authorisation in December 2025.

What did the phase 3 trials show?

Approval rested on two identical, randomized, vehicle-controlled trials published in JAMA Dermatology in 2020 (Hebert et al.). Together they enrolled 1,440 people aged 9 and older with moderate-to-severe facial acne, who applied clascoterone or an identical cream without the drug twice daily for 12 weeks. “Treatment success” meant an investigator score of clear or almost clear plus at least a two-grade improvement.

A few points stand out when you read the trial details:

• It helped both inflamed pimples and clogged pores, with the clearer separation from vehicle on non-inflammatory lesions (blackheads and whiteheads).
• It worked in males and females. The FDA Drug Trials Snapshot reports 37.5% of participants were male and says the cream “worked similarly in males and females,” and similarly in 12-to-17-year-olds and adults.
• The trial population was not diverse. According to the same snapshot, 90.3% of participants were White and 5.7% were Black, so the data say less about people with darker skin.
• The vehicle did a lot. Vehicle groups also improved, which is common in acne trials and a reminder that gentle, consistent skincare matters.

Longer-term data are weaker. In an open-label extension study reported in 2023, 598 people continued clascoterone for up to 9 more months, applying it to the face and, if they chose, the chest and back. Among those who completed the study per protocol, 48.9% had clear or almost clear facial acne at the end, and 18.1% reported an adverse event. Because everyone knew they were on the drug, there was no comparison group and only completers were counted, those figures are encouraging but not proof of long-term benefit.

Who is clascoterone for?

It is approved in the US for acne in people 12 and older. In the EU, the EMA limited adolescent use to acne on the face and said it should be prescribed by doctors experienced in treating acne.

The 2024 AAD acne guideline gives clascoterone a conditional recommendation, while topical retinoids and benzoyl peroxide get strong ones. As an MDedge summary of the guideline explains, the evidence behind clascoterone was rated high certainty, but the recommendation was kept conditional because its high price “may impact equitable acne treatment access.” So it is supported by good trials, but it isn’t meant to replace cheaper first-line options.

From what I read, it tends to come up in these situations (always a conversation with a prescriber):

• People who want a hormone-targeting option but can’t or don’t want to take pills. The AAD’s hormonal therapy page is written for women and notes that spironolactone is not prescribed for acne in men because of side effects such as breast development, while clascoterone was tested in and approved for all sexes.
• People who haven’t done well enough on, or can’t tolerate, retinoids or benzoyl peroxide.
• Teens and adults with persistent inflammatory and comedonal acne on the face, which is where the pivotal trials were done.

What I couldn’t find: head-to-head trials against retinoids, benzoyl peroxide or spironolactone. We know it beats an inactive cream; we don’t know how it ranks against other active treatments. If you’re weighing hormonal options more broadly, my overviews of hormonal acne in adults and spironolactone for acne go deeper.

How is it used?

According to the label:

• Apply a thin layer (about 1 gram) to the affected area twice daily, morning and evening.
• Keep it out of the eyes, mouth and other mucous membranes; rinse with water if it gets there.
• Avoid using more than directed. The label notes that large treated areas, prolonged use and covering the skin with dressings increase absorption into the body.
• Pharmacies store it in the fridge before dispensing. After that, discard unused cream 180 days after dispensing or one month after first opening, whichever comes first.

What are the side effects, and who should avoid it?

Local skin reactions were the most common problems in the trials. The label lists redness (12.2%), scaling or dryness (10.5%), itching (7.7%), stinging or burning (4.2%) and swelling (3.6%). The paper describes adverse events as “low and mostly mild” (Hebert et al.).

The more important warnings for clascoterone (chemically, cortexolone 17α-propionate) are about effects beyond the skin:

• HPA axis suppression. In a study designed to maximize absorption, lab evidence of suppressed adrenal hormone signaling appeared in 5% of adults (1 of 20) and 9% of adolescents (2 of 22) by day 14. All returned to normal within 4 weeks of stopping (FDA label). The label notes that younger patients may be more susceptible. This is the concern that led the EMA to initially recommend refusal, citing possible effects on growth and development in adolescents, before approving it with dose limits, monitoring and prescriber education.
• Potassium. Shifts to high potassium were seen in 5% of clascoterone users and 4% of vehicle users, a small difference.
• Pregnancy and breastfeeding. The label says there are no data in pregnant women and none on breast milk. The guideline summary likewise notes no pregnancy or lactation data, and DermNet advises against use during pregnancy and breastfeeding. See pregnancy-safe acne treatment for options with more data.

What about cost and access?

I’m not going to quote prices, because they vary by country, pharmacy, insurance plan and manufacturer programs, and change often. What I can say from the sources: the AAD guideline authors specifically flagged its high price as a barrier to equitable access (MDedge), and DermNet describes it as generally more expensive than other acne treatments. In practice, that means asking your prescriber and pharmacist what your plan covers, whether paperwork is needed before coverage kicks in, and what the lower-cost alternatives would be if it isn’t covered.

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