Efficacy and safety of fish oil supplementation combined with low-dose isotretinoin for moderate-to-severe acne vulgaris: A randomized controlled non-inferiority trial.

Abstract

Isotretinoin is a treatment for moderate-to-severe acne, but it is limited by side effects. Fish oil may reduce these side effects; however, its impact on the clinical efficacy and safety of low-dose isotretinoin in the treatment of acne vulgaris has not been evaluated. To compare the efficacy and safety of low-dose isotretinoin combined with fish oil versus low-dose isotretinoin monotherapy in moderate-to-severe acne. In this randomized, double-masked, controlled, non-inferiority trial, participants aged 18 to 25 years with an acne Investigator's Global Assessment (IGA) score ≥3 received 10-mg isotretinoin with 1-g fish oil (n = 40) or placebo (n = 40) once daily for 3 months. Outcomes included acne counts, IGA scores, skin biophysics, mucocutaneous adverse effects, serum triglyceride (TG), and liver transaminases. The fish oil group was noninferior to the placebo group in reducing total acne counts from baseline (between-group mean difference: -6.0; 95% CI: -16.5 to 4.5). Fish oil also showed smaller reductions in corneometer values and smaller increases in TG levels. The use of IGA-based inclusion criteria may have influenced the non-inferiority analysis and the 3-month duration may limit long-term interpretation. Fish oil combined with low-dose isotretinoin is noninferior and may preserve skin hydration and TG control.