A randomized, open-label study to compare two different dosing regimens of oral tranexamic acid in treatment of moderate to severe facial melasma.

Oral tranexamic acid (TXA) demonstrates promising results in melasma management. However, no clear consensus on the dosing and duration of maintenance doses of TXA therapy in melasma exists. In this study, we intend to evaluate and compare the efficacy of two different TXA dosing regimens in patients with melasma using the mMASI score. This was a randomized, open-label study wherein 50 patients (age > 18 years) with moderate to severe melasma were randomized into group A (250 mg TXA twice a day) and group B (500 mg TXA twice a day). Treatment was administered for 12 weeks and later followed up 4-weekly for next 12 weeks. The primary outcome measure was proportion of patients achieving 75% reduction in modified Melasma area and severity index (mMASI-75) at 12 weeks from baseline, reduction in mMASI and melasma quality of life (MelasQOL) score at 12 and 24 weeks. To assess the rate of relapse by end of 12 weeks post-treatment. Among 50 patients, proportion of patients achieving mMASI-75 at 12 weeks were 20% and 25% in group A and B, respectively (p-0.71). Both groups showed a significant reduction in mean mMASI (4.8 ± 2.2 in group A and 6.8 ± 3.4 in group B; p-0.02) at 12 weeks of treatment. mMASI remained stable after 12 weeks of follow-up and was 4.9 ± 2.43 and 4.93 ± 2.85 in group A and B, respectively (p-0.97). The mean percentage reduction in MelasQOL in group A and B were 41.8 ± 15.3 and 29.5 ± 21.5, respectively (p-0.03). No adverse effects were observed in both groups. Relapse rates was very less and comparable between both groups. Thus, we conclude that both dosing regimens showed comparable efficacy in terms of mMASI reduction at 12-weeks and the improvement achieved was well maintained even after 12-weeks of discontinuing treatment with very few patients relapsed. Hence, lower doses of TXA are equally effective and safe compared to higher doses and not all patients might require tapering or dosing maintenance.