A randomized, open label, comparative, five-arm, controlled study evaluating the benefit and tolerability of oral superoxide dismutase combined with gliadin as add-on neutraceutical therapy with standard therapy in Indian patients with melasma

Background: Melasma management is often difficult and unsatisfactory, and there is need to explore newer modalities for melasma treatment. Disruption in antioxidant balance occurs in melasma. Superoxide dismutase (SOD) is a cellular antioxidant and restores this balance. Our hypothesis is that the oral SOD-Gliadin can replenish the SOD stores in body and quench the ‘reactive oxygen species’-induced damage in melasma.

Methods: A randomized, open label, single centre, comparative, five arm study was conducted in 90 patients with facial mixed melasma, for 12 weeks to evaluate the efficacy, safety and tolerability of two regimens (BD & OD) of oral SOD as add-on treatment with triple combination cream in melasma patients compared with two regimens (BD & OD) of beta-carotene (BC) and placebo. Primary outcome measure was improvement in Melasma Area and Severity Index (MASI) score, and secondary outcome measures were quality of life score, patient satisfaction score, global assessment by investigator and patients. Pair-wise comparisons were performed on adjusted mean using SAS v9.1.3.

Results: There was significant reduction in MASI score with add-on treatment with SOD BD (67.97%) as compared to BC BD (43.04%), BC OD (33.68%) and placebo (22.60%). There was significant reduction in MASI score with SOD OD (51.93%) as compared to placebo (22.60%). The subjective assessments reported by patient and evaluator also ranked SOD BD as a superior regimen.

Conclusions: By inhibiting oxidative stress, nutraceutical SOD-Gliadin Combination offers significantly better efficacy and higher treatment satisfaction as add-on treatment compared to beta-carotene in Indian patients.