How to Use Winlevi (Clascoterone 1% Cream)
Apply a thin layer of approximately 1 gram of Winlevi cream to the entire affected area twice daily—once in the morning and once in the evening—after gently washing and drying the skin. 1
Application Instructions
Dosing Frequency and Amount
- Apply twice daily (morning and evening) 1
- Use approximately 1 gram per application (roughly a pea-sized amount for the entire face) 1
- Apply to the entire affected area, not just individual lesions 1
Preparation Before Application
- Wash the affected area with a gentle, non-medicated soap
- Rinse thoroughly with warm water
- Pat the skin dry gently before applying the cream 1
Application Technique
- Apply a thin layer to cover the entire affected area lightly 1
- Avoid contact with eyes, mouth, and mucous membranes 1
- Not for ophthalmic, oral, or vaginal use 1
Important Safety Considerations
Areas to Avoid
- Do not apply to damaged skin including cuts, abrasions, eczematous areas, or sunburned skin 1
- Avoid the eye area, lips, and inside of the nose or mouth 1
Managing Local Irritation
If you experience pruritus (itching), burning, skin redness, or peeling:
- Discontinue use temporarily or reduce application frequency 1
- These reactions occurred in 7-12% of patients in clinical trials 1
- Most local skin reactions were trace or mild in severity 2
Drug Interactions and Combinations
Clascoterone is stable when combined with other topical acne medications, including tretinoin, adapalene, dapsone, azelaic acid, benzoyl peroxide/clindamycin, benzoyl peroxide/adapalene, and encapsulated benzoyl peroxide 3. However, avoid concomitant use of other potentially irritating topical products initially 1.
The 2024 AAD guidelines provide a conditional recommendation for topical clascoterone, supporting its use as part of combination therapy with multiple mechanisms of action 4.
Expected Timeline for Results
- Clinical improvement typically begins around week 3-4 of treatment
- Optimal results occur at 12 weeks of continuous use 1, 2
- Treatment success rates (achieving clear or almost clear skin with ≥2-grade improvement) were 18.8-20.9% at 12 weeks in pivotal trials 1
- Long-term efficacy continues to improve: treatment success rates increased to 30.2% for facial acne after 12 months of use 5
Storage Instructions
Critical storage requirements differ before and after dispensing:
- Before opening: Store refrigerated at 36-46°F (2-8°C) 1
- After dispensing: Store at room temperature 68-77°F (20-25°C) 1
- Do not freeze at any time 1
- Discard after 180 days from dispensing date OR 1 month after first opening, whichever comes sooner 1
Patient Population
Winlevi is FDA-approved for patients 12 years of age and older with acne vulgaris 1. Post-hoc analyses demonstrate efficacy and safety are independent of age (adolescent vs. adult) and sex (male vs. female), with no statistically significant differences in efficacy between male and female patients 6.
Mechanism and Unique Benefits
Clascoterone is a first-in-class topical androgen receptor inhibitor that works by blocking androgen receptors in sebaceous glands 2, 7. It significantly reduces sebum production by 27% at 12 weeks, addressing a key driver of acne pathogenesis 8. This mechanism distinguishes it from traditional topical therapies like retinoids, benzoyl peroxide, and antibiotics.
Common Pitfalls to Avoid
- Applying to individual lesions only: Apply to the entire affected area for optimal results
- Inconsistent twice-daily application: Real-world experience shows twice-daily use leads to best overall results 7
- Improper storage: Failure to refrigerate before opening or discarding after the specified timeframe
- Applying to irritated or damaged skin: This increases risk of local reactions
- Expecting immediate results: Continue treatment for at least 12 weeks to assess full efficacy