Drug updated on 5/17/2024
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.
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Summary
- Clascoterone (Winlevi) is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older, showing significant efficacy in improving acne severity and reducing non-inflammatory lesions.
- The information was derived from a study that focused on the safety and effectiveness of clascoterone compared to placebo.
- In terms of efficacy, clascoterone significantly increased rates of treatment success compared to placebo with a risk ratio (RR) being 2.87; it also showed substantial reductions in Noninflammatory Lesion Counts but did not show a statistically significant impact on Inflammatory Lesion Counts.
- Regarding safety, there were no significant differences in the incidence of Treatment-emergent Adverse Events between the clascoterone and placebo groups, suggesting that this drug does not increase the risk of adverse events when compared to placebo.
- The incidence rate for nasopharyngitis was lower among those treated with clascoterone, indicating a potential protective effect against this condition, which may distinguish it from other treatments for acne vulgaris.
- The study's indication suggests applicability across both adolescent and adult populations suffering from acne vulgaris, although specific data on population types or subgroups was not explicitly mentioned.
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 |