What is WINLEVI cream used for?

WINLEVI cream is used for the topical treatment of acne vulgaris in patients 12 years of age and older.

How often should I apply CLASCOTERONE cream?

You should apply a thin layer of the cream twice per day, once in the morning and once in the evening.

Can I use WINLEVI cream near my eyes?

No, you should avoid accidental contact with your eyes, mouth, or other mucous membranes.

What are the common skin side effects of CLASCOTERONE?

Common skin reactions include redness, itching, and dryness or scaling of the skin.

Is WINLEVI cream safe to use during pregnancy?

There is no available data on the risks of using WINLEVI cream during pregnancy, and animal studies showed risks of birth defects.

Can children under 12 use this acne cream?

Safety and effectiveness have not been established for children under 12 years of age.

What should I do if my skin gets irritated from the cream?

If you experience redness, itching, or peeling, you should stop using the cream or reduce how often you apply it.

How should I store WINLEVI cream?

Before dispensing, it should be refrigerated between 36°F and 46°F. Once in use, store it at room temperature (68°F to 77°F).

Clascoterone | CAS 19608-29-8 | GPNHMOZDMYNCPO

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Androgen receptor antagonist

CLASCOTERONE (brand name Winlevi) is a topical cream used to treat acne vulgaris in people 12 years of age and older. It works by blocking androgen receptors in the skin.

How it worksCLASCOTERONE acts as an androgen receptor inhibitor to help treat acne.

Brand names:WINLEVI

Used for

Acne vulgaris

Conditions

Acne vulgaris

Class

Androgen Receptor AntagonistAndrogen receptor antagonistIntegumentary systemEndocrine system

How to take

FormsCream

RoutesTopical

Apply a thin layer of cream (about 1 gram) to the affected skin twice daily, once in the morning and once in the evening.

Cleanse the area gently and ensure skin is dry before applying. Do not use this cream in your eyes, mouth, or vagina.

Key warnings

·Local skin irritation such as redness, itching, or peeling may occur.
·The drug may cause suppression of your HPA axis (the system that controls hormones).
·High potassium levels (hyperkalemia) have been seen in some patients.
·Pediatric patients might be more sensitive to systemic effects.

Do not use if

·None listed

Side effects

Common

Skin rednessItchingDryness or scaling of the skinSwellingStinging or burning sensation

Serious

·Suppression of the HPA axis (hormone system)
·High potassium levels in the blood
·Severe skin irritation

Seek help if

·If you experience HPA axis suppression or high potassium, contact your doctor.

Interactions

·CASODEX
·METANDREN
·DELATESTRYL
·AVEED
·ERLEADA
·AZMIRO
·DANOCRINE
·NUBEQA
·ZYTIGA
·EULEXIN

Special populations

PregnancyThere is no data on how WINLEVI cream affects pregnant women. Animal studies showed an increased risk of birth defects and pregnancy loss at high doses.

PediatricWINLEVI is safe and effective for acne treatment in children aged 12 to 18. It has not been tested in children under 12.

GeriatricThere is not enough information on how the drug affects people over 65. Older adults should use it cautiously due to potential changes in organ function.

Talk to your doctor

Monitor

·Local skin irritation (redness, itching, scaling)
·HPA axis function
·Potassium levels

Questions to ask

·Could Winlevi affect my hormone levels?
·Is it safe to use other skin products while using Winlevi?
·How will this affect my potassium levels?

Pharmacokinetics

Protein binding84% to 89%

MetabolismMetabolized into cortexolone

Practical

StorageStore in the refrigerator (36°F to 46°F) before use. Once you start using it, keep it at room temperature (68°F to 77°F). Discard 180 days after dispensing or 1 month after opening.

Ingredients

Inactive

cetyl alcoholcitric acid monohydrateedetatate disodiummineral oilmono- and di-glyceridespolysorbate 80propylene glycolpurified watervitamin Epropylene glycolwaterglyceryl mono- and dicaprylocapratemineral oilcetyl alcoholpolysorbate 80edetate disodiumalpha-tocopherol

Educational summary derived from FDA labeling, AI-assisted. Not medical advice — consult a healthcare professional. Updated 2026-04-25.