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Clascoterone is the first genuinely new type of acne drug in decades. It does something like what spironolactone does, but only where you put it, which means men can use it and nobody needs blood tests. That is a real gap it fills. The catch is that it goes on twice a day, it is expensive, and the results are steady rather than dramatic.
The line I repeat: judge it at twelve weeks, not four. And it layers with a retinoid rather than replacing one.
— Dr. Schwarz, Board Certified Dermatologist
Key Facts
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| Also called | Winlevi |
| Drug class | Topical androgen receptor inhibitor |
| Applied as | 1% cream |
| Typical course | Long term, while acne is active |
| Time to work | About 12 weeks |
| Prescription only | Yes |
What It Is
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Clascoterone is a prescription cream approved in 2020 for acne in people aged 12 and up. It blocks androgen receptors, the docking points that male-type hormones use, inside the oil gland. It is the first topical drug to work this way. Its structure is close to spironolactone's, but it is broken down quickly once it enters the bloodstream, so its effect stays local.
How It Works
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Androgens tell oil glands to make more oil and drive some of the inflammation behind acne. That is why acne often flares at puberty, around periods, and in polycystic ovary syndrome. Clascoterone sits on the androgen receptor in the gland and blocks the hormone from binding, so the gland makes less oil and less inflammation. The obvious worry, that a hormone blocker on the skin will affect hormones everywhere, is the thing the drug was designed to avoid. It is converted to an inactive form soon after absorption. It does not act as a body-wide anti-androgen, which is why men can use it without the breast tenderness and libido effects seen with oral anti-androgens.
What It Treats
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Each grade is the same one shown on that condition’s page.
Forms and Strengths
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Dose
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Dose here means how much cream and how often. It does not depend on weight, kidney function or age.
How to Take It
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When to take it: Morning and evening, on clean dry skin, to the whole area rather than single spots. Sunscreen or moisturizer can go on top once it dries. Twice daily is the part people quietly drop, and it is the part that matters.
If you miss a dose: Apply the next one at the usual time. Do not double up.
What to Expect
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Side Effects
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Most people have either no side effects or mild local ones.
Common — expected, and they settle
- Dryness, redness, scaling and mild itch where it is applied.
Tell your doctor — worth a call, not an emergency
- Irritation that does not settle, or unusual tiredness, weakness, nausea or dizziness. In studies a small number of people showed temporary changes in adrenal hormone levels and in blood potassium, which reversed after stopping.
Stop and get care
- Swelling, blistering or hives, which suggest allergy rather than irritation.
What to Avoid
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- Applying it to broken or badly irritated skin, which raises how much is absorbed.
- Covering very large areas at once when starting, for the same reason.
- Pregnancy and breastfeeding, where safety is not established, so it is generally paused.
- There are no known food, alcohol or sun interactions. It is not a photosensitizer, though other acne treatments used alongside it may be.
Monitoring
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No routine blood tests are required for ordinary use in a healthy person. Monitoring is a review at about twelve weeks.
The exception is anyone with kidney or adrenal problems, or taking drugs that raise potassium, where a doctor may check potassium. Long term, this is a drug people can stay on. Nothing accumulates, because it is broken down quickly after absorption. In practice the recurring issue is cost and coverage, not safety.
If You Stop
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There is no rebound and no taper. The oil gland returns to responding to androgens as before, and acne generally comes back over one to three months.
Cost
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Brand only, with no generic. It is among the most expensive topical acne treatments, and insurance coverage is inconsistent. Prior authorization is common, and plans usually require a retinoid and benzoyl peroxide first. Manufacturer savings cards exist and change often.
Who Should Avoid It
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Do not take
- Known allergy to clascoterone There are no other absolute barriers. Pregnancy and breastfeeding are not listed as contraindications, but safety is not established, so it is usually paused.
Take with care
- Pregnancy Safety is not established, so it is generally paused. Benzoyl peroxide or azelaic acid are common substitutes.
- Other conditions Kidney disease or adrenal problems mean a discussion and possibly a potassium check, not automatic avoidance.
- Other medicines Potassium supplements, ACE inhibitors, ARBs and potassium-sparing diuretics are worth mentioning before starting.
How It Compares
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FAQ
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Can men use it?
Yes. That is the point of it. Because it is inactivated quickly after absorption, it does not cause the breast tenderness or libido changes that oral anti-androgens can.
Does it replace spironolactone?
Usually not. It is milder. It suits people who cannot take spironolactone, or who want to avoid a tablet and blood tests.
Do I need blood tests?
Not for routine use in a healthy person. Potassium may be checked if you have kidney disease or take drugs that raise potassium.
Can I use it with tretinoin?
Yes, and that combination is common. Clascoterone in the morning, retinoid at night.