Clascoterone

(Winlevi®)

Winlevi®

Drug updated on 10/28/2024

Dosage FormCream (topical; 1%)
Drug ClassAndrogen 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
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  • This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
  • Topical clascoterone (This study aimed to evaluate the effectiveness of topical clascoterone (TC)) 1% bis in die (BID) significantly reduced inflammatory lesions compared to placebo (SMD (standardized mean difference) = -0.27, 95% CI (confidence interval): -0.36 to -0.17) and showed higher treatment success (OR (odds ratio) = 2.44, 95% CI: 1.12 to 5.30). Another study reported increased s global assessment (IGA) success rates (Dichotomous data were analyzed using the risk ratio (RR) = 2.87, 95% CI: 2.11 to 3.89, P < .001).
  • Oral spironolactone (200 mg) was associated with a substantial reduction in total lesion count (SMD = -4.46, 95% CI: -5.60 to -3.32). Clascoterone showed similar effectiveness to other topical agents like trifarotene and tazarotene (P > 0.05).
  • Clascoterone was noted as a promising antiandrogenic treatment compared to topical antibiotics, retinoids, niacinamide, and azelaic acid.
  • There was no significant difference in the proportion of patients with treatment-emergent adverse events (TEAEs) between clascoterone and placebo groups.
  • Nasopharyngitis was significantly lower in the clascoterone group (RR = 0.47, 95% CI [0.27, 0.83], P = .01), with no significant differences for other specific adverse events such as headache, oropharyngeal pain, or vomiting.
  • There is no population types or subgroups information available in the reviewed studies.