Brand Name
Winlevi
Generic Name
Clascoterone
View Brand Information FDA approval date: October 04, 2021
Classification: Androgen Receptor Inhibitor
Form: Cream
What is Winlevi (Clascoterone)?
WINLEVI cream is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. WINLEVI cream is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
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Brand Information
Winlevi (Clascoterone)
1INDICATIONS AND USAGE
WINLEVI (clascoterone) cream is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
2DOSAGE AND 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.
WINLEVI cream is for topical use only. WINLEVI cream is not for ophthalmic, oral or vaginal use.
3DOSAGE FORM AND STRENGTHS
Cream 1%. Each gram of WINLEVI cream contains 10 mg of clascoterone in a white to almost white cream.
4CONTRAINDICATIONS
None.
5DESCRIPTION
WINLEVI (clascoterone) cream contains clascoterone, an androgen receptor inhibitor, in a cream base for topical dermatologic use. WINLEVI cream is a white to almost white cream.
Chemically, clascoterone is cortexolone-17α propionate. Clascoterone is a white to almost white powder, practically insoluble in water. The compound has the empirical formula C
Each gram of WINLEVI cream 1% contains 10 mg of clascoterone in a cream base of cetyl alcohol, citric acid monohydrate, edetate disodium, mineral oil, mono- and di-glycerides, polysorbate 80, propylene glycol, purified water, and vitamin E.
6CLINICAL STUDIES
The safety and efficacy 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 (Trial 1 [NCT02608450] and Trial 2 [NCT02608476]) enrolling 1440 subjects with facial acne vulgaris. 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 1421 subjects 12 years and older with facial acne vulgaris were enrolled. Of these subjects, 641 (45%) were 12 to 17 years of age, and 780 (55%) were 18 years of age or older. In addition, 62% of the subjects were female, and 91% were Caucasian. 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. The IGA success rate and mean absolute and percent reduction from baseline in acne lesion counts after 12 weeks of treatment for subjects 12 years of age and older are presented in the following table.
Table 2. Clinical Efficacy of WINLEVI Cream 1% in Subjects with Acne Vulgaris at Week 12
7HOW SUPPLIED/STORAGE AND HANDLING
WINLEVI cream 1% is supplied in an epoxy-lined aluminum blind-end tube with a polypropylene cap closure:
8PATIENT COUNSELING INFORMATION
- Advise the patient to read the FDA-approved patient labeling (Patient Information).
- Avoid applying WINLEVI Cream to damaged skin (such as cuts, abrasions), eczematous areas, and sunburned skin.
- Avoid concomitant use of other potentially irritating topical products (medicated or not).