The Medical Letter on Drugs and Therapeutics
Clascoterone Cream (Winlevi) for Acne
December 27, 2021 (Issue: 1640)The FDA has approved Winlevi (Sun), a 1% cream formulation of the androgen receptor inhibitor clascoterone, for treatment of acne vulgaris in patients ≥12 years old. It is the first topical androgen receptor inhibitor to be approved by the...more
- Drugs for acne. Med Lett Drugs Ther 2020; 62:188.
- DZ Eichenfield et al. Management of acne vulgaris: a review. JAMA 2021; 326:2055.
- R Grandhi and A Alikhan. Spironolactone for the treatment of acne: a 4-year retrospective study. Dermatology 2017; 233:141.
- RA Barker et al. Oral spironolactone for acne vulgaris in adult females: an update of the literature. Am J Clin Dermatol 2020; 21:303.
- JS Barbieri. A new class of topical acne treatment addressing the hormonal pathogenesis of acne. JAMA Dermatol 2020; 156:619.
- C Rosette et al. Cortexolone 17α-propionate (clascoterone) is a novel androgen receptor antagonist that inhibits production of lipids and inflammatory cytokines from sebocytes in vitro. J Drugs Dermatol 2019; 18:412.
- A Hebert et al. Efficacy and safety of topical clascoterone cream, 1%, for treatment in patients with facial acne: two phase 3 randomized clinical trials. JAMA Dermatol 2020; 156:621.
- L Eichenfield et al. Open-label, long-term extension study to evaluate the safety of clascoterone (CB-03-01) cream, 1% twice daily, in patients with acne vulgaris. J Am Acad Dermatol 2020; 83:477.
- A Mazzetti et al. Pharmacokinetic profile, safety, and tolerability of clascoterone (cortexolone 17-alpha propionate, CB-03-01) topical cream, 1% in subjects with acne vulgaris: an open-label phase 2a study. J Drugs Dermatol 2019; 18:563.
The Medical Letter is a subscriber-funded nonprofit organization that publishes critical appraisals of new prescription drugs and comparative reviews of drugs for common diseases.