Medication

Winlevi

The first cream that blocks hormones in the skin itself. It is the only topical treatment that works on the hormonal driver of acne, and it can be used by men and women.
A white metal tube lying at an angle on a white background, white ribbed cap to the left, labeled Clascoterone in blue lettering with a blue swoosh curving beneath the word.

Start here

I have a complicated relationship with Winlevi. We use it for hormonal acne in women who are not ready for a pill — birth control or spironolactone. It works about 50% of the time, and when it works it works; otherwise nothing at all. It is expensive and needs refrigerating, and spironolactone is far cheaper if a pill is acceptable.

— Dr. Schwarz, Board Certified Dermatologist

Key Facts

Also calledWinlevi
Drug classTopical androgen receptor inhibitor
Applied as1% cream
Typical courseLong term, while acne is active
Time to workAbout 12 weeks
Prescription onlyYes

What It Is

Clascoterone is a prescription cream for acne from age 12, approved in 2020. It blocks the androgen receptors male-type hormones dock onto inside the oil gland, the first topical drug to work that way. Its structure is close to spironolactone's, but it breaks down quickly once absorbed, so the effect stays local.

How It Works

Androgens tell oil glands to make more oil and drive some of the inflammation behind acne, which is why acne flares at puberty, around periods, and in polycystic ovary syndrome. Clascoterone blocks that receptor in the gland, so it makes less oil and less inflammation.

A hormone blocker on the skin sounds like it should affect hormones everywhere; this one is converted to an inactive form soon after absorption, so it does not. That is why men can use it without the breast tenderness and libido changes of oral anti-androgens.

Here is where Winlevi acts in the skin, and what the others do instead.

About Winlevi
Compare
Skin basics
BARRIEREPIDERMISDERMISPOREOILGLANDLOWERS OIL PRODUCTIONCROSSES EASILYSTOPS PLUGS FORMINGUNCLOGS THE POREKILLS BACTERIAKILLS YEASTKILLS MITES

Winlevi works upstream of the spot, on the gland itself. Less oil means fewer plugs, less for bacteria to feed on and less inflammation, which is why it changes the pattern rather than clearing one spot. A cream that blocks the hormone signal in the skin only, so it suits men and women.

Clascoterone crosses the barrier and then breaks down quickly in the skin. Getting in easily and leaving fast is the whole design: it blocks the hormone signal in the oil gland without doing anything elsewhere.

Retinoids change how the lining of the pore sheds its cells, so the plug that starts a spot stops forming in the first place. That is why they prevent spots rather than treat the ones already there, and why the first weeks can look worse before they look better.

Salicylic acid dissolves in oil, so it gets down inside the pore rather than sitting on the surface, and loosens the plug of dead skin and sebum blocking the way out.

This works on the bacteria growing in an inflamed pore. Less bacteria means less for the immune system to react to, which is what takes the redness and soreness out of a spot.

The yeast involved here lives on everyone's skin and only causes trouble when it overgrows in oil. This reduces it, which is why the flaking and itching settle and why it comes back if treatment stops for good.

Everyone carries these mites in their follicles. In some people the immune system reacts to them, and reducing their number reduces the bumps and the redness that come with them.

The outer film of dead cells and oil. It holds water in and keeps irritants out, and it is thinner than a sheet of paper. Almost every dry, itchy, stinging skin problem starts here.

The outer layer, and the only one anything in a jar reaches. It renews itself constantly: a cell made at the bottom takes about a month to reach the surface and flake off. Most of what a skincare product does, it does here.

The living layer underneath, holding the blood vessels, the nerves and the collagen. It is where lasting change happens and it is hard to reach: most of what is sold for the skin never gets this far.

What It Treats

Close-up of a cheek with inflamed acne. Raised pink-red bumps, a few with yellow-white heads, sit in a patch of redness, and the skin between them is dry and flaking.
Moderate evidence
Blocks the hormone signal that drives oil production, but only where you put it. It is the first hormonal option that works topically, and the only one that can be used by men as well as women.

Not the Best For

Two skin close-ups side by side, labeled Whitehead (Closed Comedone) and Blackhead (Open Comedone)
Blackheads and whiteheads
Doesn't work
Clascoterone blocks the hormone signal inside the skin, which lowers oil and calms inflammation. The plug inside the pore is untouched.
16:9 hero for Female Pattern Hair Loss. Never cropped: the tone strip and the corner logo depend on the full frame.
Hair loss or unwanted hair growth
Doesn't work
The same hormone blocking is being studied for scalp hair loss under a different product. Winlevi is approved for acne on the face and trunk, and that is what it should be used for.

Forms

One product only
There is no gel or lotion version.
A white cream tube lying on its side on a white background, with a plain white label reading Winlevi Cream and a blue swoosh beneath it.
In a tube
Cream
The only form it is sold in.

Strengths

One strength only.

The only strength
1%
Nothing stronger or weaker.

Basics

When to Apply
Twice a day, morning and night, on clean dry skin. A fingertip of cream over the whole area. Sunscreen or moisturizer goes on top once it dries.
How to Start
Twice daily from day one — and twice daily is the part people quietly drop.
If It Irritates
Mild dryness or redness early on is usually the base, not the drug, and moisturizer underneath settles it.
If It’s Not Working
One strength, so nothing to increase. Give it twelve weeks, then ask about adding another treatment.

Sample Routine

Here is where Winlevi sits in a day, and what goes around it. Pick what you are treating and what your skin is like, and the rest of the routine changes to suit.

What to Expect

Weeks 1 to 4Weeks 4 to 8After 12 weeks
Weeks 1 to 4
Little visible change, maybe mild dryness.
Weeks 4 to 8
Oiliness often drops before spot counts.
After 12 weeks
Judge it here. Trials measured their main result here, and many kept improving past it.

What to Avoid

  • Broken or badly irritated skin More is absorbed through broken skin.
  • Covering large areas at once Same reason. Build up rather than starting everywhere on day one.

Monitoring

No routine blood tests in a healthy person. Monitoring is a review at about twelve weeks.

The exception is kidney or adrenal problems, or drugs that raise potassium — then a doctor may check it. People can stay on it long term; nothing accumulates, because it breaks down quickly after absorption. The recurring issue is cost and coverage, not safety.

If You Stop

No rebound and no taper. The oil gland responds to androgens again, and acne generally comes back over one to three months.

Cost

Brand only, no generic. Among the most expensive topical acne treatments, with inconsistent coverage. Prior authorization is common, and plans usually want a retinoid and benzoyl peroxide first. Savings cards exist and change often.

Ask Your Doctor

Pregnancy or breastfeeding
No reliable data, so it is generally paused. Ask before starting or continuing.
An allergy to clascoterone
The only absolute barrier.
If the irritation does not settle
It should ease over the first weeks.
If you feel tired, weak, sick or dizzy
A few people in studies had temporary hormone and potassium changes, reversing on stopping.

How It Compares

An amber prescription bottle lying on its side on a white background with a plain white label reading Spironolactone, and six small round white tablets spilled out in front of it.Diagram: how Spironolactone works in the skin
Spironolactone
The same
works on the same hormone pathway but throughout the body, as a tablet, generally for women only. Cheaper and stronger, needs more caution.
Topical retinoids
Different job
work on the clog rather than the hormone. Different target, so the two combine well.
Three acne wash tubes on white: Differin Deep Cleanser, CeraVe Acne Foaming Cream Cleanser and PanOxylLabeled cutaway diagram of a single skin pore. The epidermis is drawn as a brick-textured layer across the top and the dermis in pink below it, with a yellow oil gland at the base of the pore. Three callout lines point into the pore: decreases dead cells in pore near the opening, kills bacteria at the cluster of bacteria deep in the shaft, and decreases inflammation in the surrounding dermis.
Benzoyl peroxide
Different job
targets bacteria. Also combines well.
Clascoterone is the only option here that treats the hormonal driver without body-wide effects, which is its whole case.
Different job

Myths

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  • "It is a hormone pill." It is a cream. It blocks androgen receptors in the skin, and too little reaches the bloodstream to cause the body-wide effects the tablets can.
  • "Men cannot use it." Approved for males and females from age 12. The hormonal acne treatments restricted to women are the oral ones.
  • "You cannot use anything else with it." Routinely used alongside benzoyl peroxide or a retinoid.
  • "It makes you sun-sensitive." No, and no known food or alcohol interactions either. Other acne treatments used with it can, which is where the idea comes from.

Questions Patients Ask

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Can men use it?

Yes. It is inactivated quickly after absorption, so it skips the breast tenderness and libido changes of oral anti-androgens.

Does it replace spironolactone?

Usually not. It is milder, for people who cannot take spironolactone or want to avoid a tablet and blood tests.

Do I need blood tests?

Not for routine use. Potassium may be checked with kidney disease or drugs that raise it.

Can I use it with tretinoin?

Yes, a common combination. Clascoterone in the morning, retinoid at night.

References

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