A Prospective, Randomized and Open Label Study to Compare Efficacy, Safety and Quality of Life Impact of Topical Glutathione (2%) in Comparison to Topical Tranexamic Acid (3%) in Adult Melasma Patients

Abstract

Background: The most common cause of facial melanoses is melasma. There is no universally efficacious melasma therapy and the gold standard therapy (triple combination cream) has multiple long term adverse effects. Topical glutathione is a relatively novel drug acting on key melasma pathology features.
Objectives: This is first study to compare efficacy, safety and quality of life (QoL) impact of topical glutathione (2%) with topical tranexamic acid (TA) (3%) in adult melasma patients.
Design: Randomized, prospective, parallel and open label.
Methods: This study compared topical glutathione (2%) (Group A, n = 30) with topical TA (3%) (Group B, n = 30) in 60 adult melasma patients for 3 months. Evaluation of efficacy was done through Modified Melasma Area Severity Index (mMASI score) & Physician Global Assessment (PGA) score on 30, 60 and 90 days. QoL was assessed through Melasma Quality of Life score (MELASQOL) and photographs were taken at 0 &90 days. Adverse effects were reported every 30 days.
Results: Both groups exhibited improvement in mMASI & PGA score at 30 days, but statistically significant improvement (p <0.001) was observed from 60 to 90 days. Group A was significant over Group B in improving mMASI (p <0.001) and PGA score (p <0.001) from 60 days to 90 days. Both groups had a comparable safety profile (p > 0.05) with no serious adverse effects.
Conclusion: Topical glutathione showed better efficacy, QoL improvement and comparable safety to topical TA over 3 months in melasma.