Clascoterone in the Treatment of Acne Vulgaris: A Narrative Review

Acne vulgaris is one of the most prevalent dermatological conditions, affecting up to 85% of individuals aged 11–30 years. Clascoterone cream is the first topical androgen receptor inhibitor approved by the U.S. Food and Drug Administration (FDA) for the treatment of acne vulgaris in patients aged 12 years and older, and the first agent in this class approved for use in both male and female patients. The aim of this narrative review is to summarize the current evidence regarding the efficacy, safety profile, and potential future applications of clascoterone in the treatment of acne vulgaris. A comprehensive literature search was conducted in PubMed/MEDLINE and ClinicalTrials.gov databases up to April 2026. Search terms included “clascoterone,” “cortexolone 17α-propionate,” and “androgen receptor inhibitor acne.” Eligible publications included randomized controlled trials, meta-analyses, open-label extension studies, retrospective analyses, case reports, and relevant review articles published in English. Clinical trial registries and regulatory agency announcements were also searched for ongoing studies and recent approval decisions. Phase 3 trials and meta-analyses demonstrate that twice-daily application of clascoterone 1% cream significantly reduces inflammatory and non-inflammatory lesion counts compared to vehicle, with efficacy sustained up to 12 months of treatment. The safety profile is favorable, with adverse events limited predominantly to mild and transient local skin reactions. Subgroup analyses have shown no significant sex-related differences in efficacy or safety, and the safety profile appears comparable between adolescents and adults. In an exploratory pooled subgroup analysis, lesion-count reductions were greater in adults than in adolescents, whereas the adjusted between-group comparison of IGA success was not statistically significant. Because no formal treatment-by-age interaction test was reported, these findings should be considered hypothesis-generating. Emerging but still incomplete data suggest potential applications in androgenetic alopecia and mild hidradenitis suppurativa. Clascoterone represents a novel addition to the therapeutic armamentarium for acne vulgaris, offering a unique mechanism of action with a favorable safety profile. Further research is warranted to establish its role in combination therapies and in other androgen-dependent dermatoses.