Drug updated on 3/28/2024
| Dosage Form | Cream (topical: 1%) |
| Drug Class | Androgen receptor inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For the topical treatment of acne vulgaris in patients 12 years of age and older.
Summary
- Clascoterone (Winlevi) is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
- A systematic review and meta-analysis was conducted on a total of one document, which included five clinical trials involving 2457 patients with acne vulgaris.
- The patient population consisted mainly of individuals aged 12 years or older suffering from acne vulgaris; no specific subgroup considerations were mentioned in the reviewed document.
- Compared to placebo, clascoterone (Winlevi) significantly increased investigator's global assessment success rates and decreased noninflammatory lesion counts without substantially impacting inflammatory lesion counts.
- In terms of safety outcomes, there were no significant differences between clascoterone (Winlevi) and placebo groups except for nasopharyngitis incidence which was significantly lower in the clascoterone group.
- Based on these findings, it can be concluded that topical application of clascoterone (Winlevi) is safe and effective for treating acne vulgaris among patients aged 12 years or older.
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 |