Topical Clascoterone: The First Novel Agent for Acne Vulgaris in 40 Years

Clin Ther. 2021 Oct;43(10):1638-1644. doi: 10.1016/j.clinthera.2021.08.007. Epub 2021 Oct 2.


Purpose: Acne vulgaris is a ubiquitous condition in men and women starting in adolescence. It is often persistent and refractory to multiple treatment methods. Although multiple medications may be used on- or off-label for treatment, many adverse effects and risks exist with these treatments, and there has not been an agent with a novel mechanism of action introduced in 40 years. Clascoterone is a recently approved topical acne medication with the first novel mechanism of action since isotretinoin. The purpose of this article was to review the clinical data regarding the safety and efficacy of topical clascoterone for the treatment of acne vulgaris in male and female subjects aged >12 years.

Methods: A literature search of PubMed, EMBASE, and MEDLINE was conducted for clinical trials published between January 2014 and March 2021 in the English language using the key words Winlevi, clascoterone, and acne vulgaris. Articles were selected if they were related to the approval by the US Food and Drug Administration of clascoterone or provided novel data regarding this drug entity.

Findings: Two Phase III randomized controlled trials (NCT02608450 and NCT02608476) were ultimately selected, as these trials provided pivotal information to the US Food and Drug Administration for the approval of topical clascoterone.

Implications: The findings of this review show that topical clascoterone is likely an effective and safe option for the treatment of acne vulgaris. It offers efficacy rates similar to those of current medications through a novel mechanism of action. Its place in therapy remains unclear, but it might be placed ahead of other androgen receptor antagonists such as spironolactone due to its avoidance of systemic side effects.

Keywords: Acne vulgaris; Ambulatory care; Clascoterone; Winlevi.

Publication types

  • Review

MeSH terms

  • Acne Vulgaris* / drug therapy
  • Adolescent
  • Androgen Receptor Antagonists
  • Cortodoxone / analogs & derivatives
  • Female
  • Humans
  • Male
  • Propionates*
  • Treatment Outcome


  • Androgen Receptor Antagonists
  • Propionates
  • Cortodoxone
  • Clascoterone

Associated data