How long does Winlevi take to work for acne?

You may notice a reduction in your acne as early as 4 weeks, with a full effect at 3 months. Winlevi 1% cream, when applied twice daily in 12-week long studies, was shown to have a significant effect in reducing acne lesions (pimples, whiteheads, blackheads) in people 12 years of age and older. Clinicians rated patients as having clear or almost clear skin at 3 months.

What is Winlevi?

Winlevi (clascoterone) cream 1% is a prescription topical medicine approved by the FDA in August 2020 to treat acne vulgaris in patients 12 years and older.

In clinical studies, Winlevi demonstrated reductions in acne lesions and was well-tolerated. It is applied as a thin layer to the affected area (face, chest, shoulders, and/or back) twice daily (morning and evening). Use this medicine exactly as your healthcare provider tells you to use it.

It is a first-in-class topical androgen receptor inhibitor and was the first medicine approved in over 40 years with a new way of working in acne treatment.

It is manufactured by Sun Pharmaceuticals.

How well does Winlevi work?

Winlevi studies for acne

Winlevi was evaluated in 12-week long, vehicle-controlled studies in 1421 subjects 12 years and older with facial acne vulgaris. Most patients (83%) had moderate acne as determined by the investigator. Winlevi was applied topically twice daily. The vehicle is the cream formulation, but without the active medicine.

The primary endpoint was the Investigator Global Assessment (IGA) success and was defined as at least a 2-point reduction in IGA compared to baseline and an IGA score of 0 (clear) or 1 (almost clear). Absolute change and percent change from baseline in non-inflammatory and inflammatory lesions were also measured.

• The IGA success rate in 2 studies after 12 weeks was 18.8% and 20.9% for Winlevi compared to 8.7% and 6.6% for the vehicle group.
• The Mean Percent Reduction in non-inflammatory lesions was 32.6% and 29.8% for Winlevi compared to 21.8% and 15.7% for the vehicle group.
• The Mean Percent Reduction in inflammatory lesions was 44.6% and 47.1% for Winlevi compared to 36.3% and 29.7% for the vehicle group.
• All primary clinical endpoints were found to be highly statistically significant.

The most common side effects occurring in 7 to 12% of patients were:

• erythema (skin redness)
• itching
• scaling or dryness

Hypothalamic-pituitary-adrenal (HPA) axis suppression was observed in 2 of 22 (9%) adolescent subjects and was reversible upon treatment discontinuation. HPA axis suppression is a disorder where the adrenal gland does not make enough of certain hormones like cortisol (called adrenal insufficiency).

This is not all the information you need to know about Winlevi (clascoterone) for safe and effective use and does not take the place of your doctor’s directions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.

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