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Topical Clascoterone Cream Safe, Efficacious in Facial Acne Vulgaris Treatment


Researchers conducted a pooled data analysis using previous study data to determine the cream’s efficacy in patients ages 12 and up.

Researchers have deemed topical 1% clascoterone cream to be both safe and effective in treating patients ages 12 and older with facial acne vulgaris.1

Photo: Africa Studio/Adobe Stock

Photo: Africa Studio/Adobe Stock

In their recent examination of the treatment, researchers sought to analyze previous study results byusinga pooled data analysis. The analysis was published in the Journal of Drugs in Dermatology in March 2023. 

In reviewing the previous study results, researchers went in with the objective of analyzing the safety and efficacy of topical clascoterone cream in patients ages 12 and older, as opposed to 9 and older.

Previously, researchers conducted two randomized, double-blind, phase 3 trials to determine the treatment’s efficacy in patients 9 years of age or older.2 Trial results were first published to JAMA Dermatology in April 2020.

Within these trials, researchers analyzed clascoterone, a novel topical androgen receptor inhibitor, and its impact on 1440 participants presenting with acne vulgaris. All participants had moderate to severe acne vulgaris in accordance with the Investigator Global Assessment (IGA). Study participants were asked to apply 1 gram of topical clascoterone cream to their faces on a twice-daily basis for a series of 12 weeks.

In comparison to the vehicle control treatment, participants utilizing the topical clascoterone cream experienced greater reductions in the amount of noninflammatory and inflammatory lesions. Any adverse events (AE) experienced were mild, experienced at a low rate, and comparable in nature to those experienced by participants in the control group. The most predominant AE was reported to be facial redness.

Researchers assessed the studies in terms of efficacy (using the IGA and determining absolute change from a patient’s initial baseline score), and safety (with respect to both treatment-emergent adverse events and local skin reactions).

Study limitations included the exclusion of potential participants who would have been simultaneously using other acne treatments. Researchers also did not conduct an analysis of the treatment and its potential impact on patient quality of life.

“Clascoterone is efficacious, with a favorable safety profile and low rates of local skin reactions in patients ≥12 years of age with facial acne vulgaris,” the study said. “[f]urther studies are needed to investigate the efficacy and safety of 1% clascoterone cream in combination with other topical acne medications.”


1. Hebert AA, Eichenfield LF, Thiboutot D, et al. Efficacy and safety of 1% clascoterone cream in patients aged ≥ 12 years with acne vulgaris. J Drugs Dermatol. Published online February 1, 2023. doi:10.36849/JDD.7000

2. Hebert A, Thiboutot D, Stein Gold L, et al. Efficacy and safety of topical clascoterone cream, 1%, for treatment in patients with facial acne.JAMA Dermatology. 2020;156(6):621. doi:10.1001/jamadermatol.2020.0465

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