Drug updated on 9/4/2024
Dosage Form | Cream (topical; 1%) |
Drug Class | Androgen receptor inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
Latest News
Summary
- 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.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Winlevi (clascoterone) Prescribing Information. | 2021 | Sun Pharmaceutical Industries, Inc. Cranbury, NJ |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Efficacy and safety of topical clascoterone cream for treatment of acne vulgaris: a systematic review and meta-analysis of randomized placebo-controlled trials. | 2021 | Dermatologic Therapy |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Guidelines of care for the management of acne vulgaris. | 2024 | Journal of the American Academy of Dermatology |