General Information

Winlevi (clascoterone) is an androgen receptor inhibitor.

Winlevi cream is specifically indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

Winlevi is supplied as a cream for topical administration. Cleanse the affected area gently. After the skin is dry, apply a thin uniform layer of Winlevi cream twice per day, in the morning and the evening, to the affected area. Avoid accidental transfer of Winlevi cream into eyes, mouth or other mucous membranes. If contact with mucous membranes occurs, rinse thoroughly with water.

Mechanism of Action

Winlevi (clascoterone) is an androgen receptor inhibitor. The mechanism of action of Winlevi cream for the topical treatment of acne vulgaris is unknown.

Side Effects

Adverse effects associated with the use of Winlevi may include, but are not limited to, the following:

• erythema/reddening
• pruritus
• scaling/dryness
• edema
• stinging
• burning

Clinical Trial Results

The FDA approval of Winlevi cream 1% applied twice daily for 12 weeks for the treatment of acne vulgaris were assessed in two identically-designed, multicenter, randomized, double-blind, vehicle-controlled clinical trials. The trials enrolled subjects 9 years or older with Investigator’s Global Assessment (IGA) of moderate or severe facial acne vulgaris (score of 3 or 4), 30 to 75 inflammatory lesions (papules, pustules and nodules), and 30 to 100 non-inflammatory lesions (open and closed comedones). A total of 1,421 subjects 12 years and older with facial acne vulgaris were enrolled. At baseline, subjects had a mean inflammatory lesion count of 42.4 and a mean non-inflammatory lesion count of 61.4. Additionally, approximately 83% of subjects had an IGA score of 3 (“moderate”). Efficacy was assessed at Week 12 by the proportion of subjects in each treatment group with 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. IGA Success: Trial 1: 18.8% for Winlevi versus 8.7% for placebo. Trial 2: 20.9% for Winlevi versus 6.6% for placebo. At week 12, treatment with clascoterone cream 1%, resulted in a significant reduction in absolute noninflammatory lesions from baseline to −19.4 (both trials) versus −13.0 and −10.8 with placebo, respectively, as well as a reduction in inflammatory lesions from baseline to −19.3 and −20.0 versus −15.5 and −12.6 with vehicle, respectively.