Drug updated on 10/28/2024
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
- 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.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Winlevi (clascoterone) Prescribing Information. | 2021 | Sun Pharmaceutical Industries, Inc. Cranbury, NJ |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Guidelines of care for the management of acne vulgaris | 2024 | Journal of the American Academy of Dermatology |