in male patients, were not observed with topical clascoterone treatment.44 The most frequently observed new or worsening local skin reactions were erythema and scaling/dryness, but no systemic adverse reactions were reported.43,44 The long-term safety profile of clascoterone applied to the face and/or trunk was favorable and consistent with previous trials, with no sex-related differences reported; most treatment-related adverse events were mild or moderate.44
Based on these data, clascoterone cream 1% was approved by the FDA in 2020 for the topical treatment of acne vulgaris in patients 12 years of age and older.45
Identification of the Place of Clascoterone in Acne Therapy: Expert Perspectives and Considerations
Clascoterone has potential as a foundational drug for the treatment of moderate to severe comedonal and inflammatory acne in patients ≥12 years old of age of any sex at any level of acne severity.
Clascoterone is the first topical hormonal medication that specifically addresses sebum production in acne40 and has a favorable safety profile in adult and adolescent patients, including males.43 Because of its rapid hydrolysis to cortexolone, clascoterone can target androgen-stimulated sebaceous gland
