A novel therapy for the treatment of acne vulgaris is now available. Clascoterone is a topical androgen receptor inhibitor indicated for use in people aged 12 years and older.

Androgens stimulate sebum production and play an important role in the pathogenesis of acne. Systemic antiandrogen therapies such as spironolactone and cyproterone have been successfully used in the management of acne. However, these medications can only be used for the treatment of acne in females.

Topical clascoterone has limited systemic antiandrogenic effects and can be used by males and females. The safety and efficacy of clascoterone were demonstrated in two Phase 3 trials. Clascoterone cream was significantly more effective than the vehicle cream, with 18.4% and 20.3% of patients in the active groups achieving treatment success at week 12, compared to 9.0% and 6.5% in the respective placebo groups.

Clascoterone cream is recommended to be applied twice a day as a thin uniform layer to clean dry skin. Studies demonstrate that the safety profile of clascoterone cream is similar to that of the vehicle, and adverse effects are infrequent and mild in nature. Long-term studies have not found any systemic antiandrogenic effects in males. However, to minimise systemic absorption, occlusive dressings should not be applied to the treated area.


  1. Hebert A, Thiboutot D, Stein Gold L, Cartwright M, Gerloni M, Fragasso E, 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(6): 621-630.
  2. Santhosh P, George M. Clascoterone: a new topical anti-androgen for acne management. Int J Dermatol. 2021; 60(12):1561-1565.
  3. Winlevi® (Clascoterone) Australian approved product information. Macquarie Park: Sun Pharma. Approved March 2024.

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