Use this clascoterone checklist to track twice-daily use, lesion changes, and skin irritation, ask about hormone, potassium, and pregnancy risks, and verify skin condition, other topicals, and storage. Clascoterone, sold as Winlevi cream 1%, is a topical androgen-receptor inhibitor that blocks dihydrotestosterone at the sebaceous gland to reduce sebum and inflammation. The FDA approval notice states that Winlevi was approved in August 2020 for acne vulgaris in patients 12 years and older, as the FDA approval notice documents. It was the first acne drug with a new mechanism in nearly 40 years.
Medical information disclaimer: This article is for general educational purposes only and does not provide medical advice, diagnosis, or treatment. Always consult a physician or other qualified health professional about symptoms, medications, tests, or treatment decisions.
Table of Contents
- How do you apply it correctly?
- What improvement should you track at 12 weeks?
- What skin reactions need action?
- What should you ask and verify first?
How do you apply it correctly?
Wash and dry the skin first, then apply a thin uniform layer to affected areas only in the morning and evening. The NLM DailyMed WINLEVI label directs about 1 g per application and warns to avoid eyes, mouth, and mucous membranes, as described in the NLM DailyMed WINLEVI label. Use a simple routine you can repeat and check off:.
- wash, dry fully, then apply thin layer only where acne occurs
- use morning and evening, about 1 g each time
- keep cream away from eyes, lips, mouth, and nose openings
What improvement should you track at 12 weeks?
In two identical 12-week phase 3 trials in 1,440 patients with moderate-to-severe facial acne, clascoterone reduced inflammatory and noninflammatory lesions more than vehicle. Track lesion counts, redness, pain, and Investigator's Global Assessment change, not day-to-day bumps alone.
Expect partial improvement rather than full clearing. The Pharmaceuticals narrative review of the trials defines success as clear or almost-clear plus at least 2-grade improvement, seen in 19.9% on drug versus 7.7% on vehicle, according to the Pharmaceuticals narrative review. Record photos, lesion numbers, missed doses, and other acne products so the 12-week trend is clear.
What skin reactions need action?
Watch for erythema, itching, and scaling or dryness. The FDA label via Drugs.com reports these in 7–12% of patients, with edema, stinging, and burning in over 3%, as listed in the FDA label via Drugs.com prescribing info.
Pause use or use less often if burning, stinging, swelling, or peeling starts. Note onset date, location, severity, and what eases it. Seek prompt care for severe irritation, swelling, allergy signs, or symptoms suggesting adrenal or potassium problems such as unusual fatigue, weakness, or dizziness.
What should you ask and verify first?
Ask about adrenal-axis suppression during or after treatment, higher systemic-toxicity susceptibility in younger patients, and potassium elevation seen in trials. List all prescription drugs, corticosteroids, potassium-related drugs, and supplements before starting.
Verify pregnancy and breastfeeding status, since no human data exist and high doses harmed fetuses in animals. Do not apply to cuts, scrapes, eczema, or sunburn, and avoid harsh soaps, scrubs, and other irritating topicals unless directed. Store at 20–25°C without freezing, and discard 180 days after dispensing or 1 month after opening.