Summary

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• Winlevi (clascoterone) is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
• This summary is based on the review of one systematic review(s)/meta-analysis(es). ^[1]
• Investigator's Global Assessment (IGA) Treatment Success: Clascoterone significantly increased IGA treatment success rates with a Risk Ratio (RR) of 2.87 (95% CI [2.11, 3.89], P < .001), indicating that patients were nearly three times more likely to achieve treatment success compared to placebo.
• Noninflammatory Lesion Counts (NILCs): Clascoterone significantly decreased NILCs with a Mean Difference (MD) of -5.64 (95% CI [-8.41, -2.87], P < .01), reflecting a substantial reduction in noninflammatory lesions in the treated group.
• Inflammatory Lesion Counts (ILCs): Clascoterone did not significantly reduce ILCs, with a Mean Difference (MD) of -1.82 (95% CI [-5.06, 1.43], P = .27), showing no substantial impact on the number of inflammatory lesions.
• There were no significant differences between clascoterone and placebo in the incidence of most treatment-emergent adverse events, including serious adverse events, events related to the study drug, and events leading to discontinuation.
• Clascoterone was associated with a significantly lower incidence of nasopharyngitis compared to placebo (Risk Ratio = 0.47, 95% CI [0.27, 0.83], P = .01).
• There is no population types or subgroups information available in the reviewed studies.