Efficacy of oral isotretinoin monotherapy compared to combination isotretinoin and topical clascoterone for severe acne vulgaris: a multi-center retrospective study.

Abstract

Introduction: Severe nodular acne causes significant psychological distress and reduces quality of life. Clascoterone 1% cream, a novel anti-androgen with a favorable safety profile, may enhance the efficacy of oral isotretinoin, the gold-standard therapy for severe acne. This study compared isotretinoin monotherapy with isotretinoin plus topical clascoterone 1% cream.

Methods: Since June 2023, patients with severe/nodular acne at university-affiliated dermatology clinics were treated with isotretinoin, alone or combined with clascoterone 1% cream twice daily. In December 2024, records were retrospectively reviewed. The analysis included patients aged ≥12 years with severe/nodular acne who received isotretinoin (0.5-0.8 mg/kg/day) with or without clascoterone 1% cream for ≥24 weeks. Outcomes included facial lesion count, Investigator's Global Assessment (IGA), and facial xerosis at week 24.

Results: Eighty-two patients (44 monotherapy; 38 combination therapy) were included. Both groups showed significant reduction in facial lesion count (p < 0.001), but between-group differences were not significant. More patients in the combination group achieved IGA 0/1 (92.1% vs. 72.7%; p < 0.05). Xerosis rates were lower in the combination group (84% vs. 91%) but not statistically significant.

Conclusion: Clascoterone 1% cream may enhance isotretinoin efficacy without worsening adverse effects, offering a promising approach for severe/nodular acne. Further studies are needed to confirm long-term benefits.