Comparative Efficacy and Safety of Low Dose versus High Dose Isotretinoin in Severe Acne Vulgaris Patients

Abstract

Background: Oral isotretinoin is the recommended treatment for acne vulgaris, a skin disease especially common in teenagers and adolescents. This study was designed to compare the efficacy and safety of low dose with high dose isotretinoin in severe acne vulgaris patients.Material and Methods: This randomized controlled trial included 110 patients with a clinical diagnosis of acne vulgaris. They were divided into two groups. Both groups were matched for age (mean 18.2±3.7 vs 17.6±3.2 years), weight (mean 58±10.2 vs 60.7±9.3 Kg), gender and disease duration (3±1.1 vs 3±1.0 years). Group A received low dose oral isotretinoin (20 mg/day) while group B received standard high dose regimen (1mg/kg/day). All patients were followed up for 16 weeks to assess efficacy (assessment of complete remission) and safety (mucocutaneous side effects). All calculations were performed using SPSS v. 16 with p value <0.05 considered as statistically significant.Results: There was no statistically significant difference in efficacy. However, significantly fewer mucocutaneous side effects were reported in group A (80%) as compared to group B (100%). This safety profile spectrum was observed across all pre-defined subsets i.e chielitis (78.1% vs 98.2%), dry skin (69.1% vs 92.7%), dry mouth (47.2% vs 72.7%) and facial rash (12.7% vs 30.9%).Conclusion: In patients with severe acne vulgaris, efficacy (complete remission) of low dose oral isotretinoin is almost equal to conventional high dose regimen but it is statistically superior in terms of safety (mucocutaneous side effects).