Objective: To synthesize current clinical evidence on clascoterone for acne vulgaris and discuss its potential application in Vietnam.
Search methods and review: Narrative review. PubMed/MEDLINE, Google Scholar, and Cochrane Library were searched (January 2011–May 2026) using the terms clascoterone, cortexolone 17α-propionate, and acne vulgaris. Eligible sources included phase III trials, systematic reviews/meta-analyses, international guidelines, and FDA regulatory documents.
Results: Ten publications were included. Two phase III trials (n = 1,440) showed treatment success rates of 18.4–20.3% with clascoterone versus 6.5–9.0% with vehicle (p < 0.001) [3]. A network meta-analysis of 7 RCTs found OR = 2.44 (95% CI 1.12–5.30) versus vehicle, not a direct comparison with spironolactone [6]. The 2024 AAD guideline issued a conditional recommendation for patients aged 9 years and older; the FDA-approved indication is limited to patients 12 years and older [3,8]. The drug currently has no confirmed marketing authorization in Vietnam.
Conclusion: Clascoterone is effective and well tolerated in vehicle-controlled trials. Its use in Vietnam should be considered pending verification of regulatory status, cost-effectiveness data, and guideline updates.