Randomized Clinical Trial on the Efficacy of Oral Tranexamic Acid Versus Topical Tranexamic Acid in Treatment of Melasma.

backgroundMelasma is a prevalent skin condition that primarily affects females of reproductive age. Despite the various available treatments, managing melasma is challenging due to frequent relapses and partial responses. Tranexamic acid (TXA) has gained attention as a potential treatment because of its antifibrinolytic and anti-melanogenic properties. However, there is still limited information on the efficacy of oral versus topical TXA formulations.

aimThe present investigation explored the efficacy and safety of topical versus oral TXA in melasma patients to determine whether topical administration could provide a viable alternative with improved tolerability. PATIENTS/

methodsIn this single-center randomized trial, 50 melasma patients received oral TXA (250 mg twice daily) or topical TXA (a 5% cream applied twice daily) for 12 weeks. Melasma severity was measured using the Melasma Area and Severity Index (MASI) score at baseline and after 3 months. Data analysis was performed using SPSS version 24, with p < 0.05 considered statistically significant.

resultsFifty female patients (mean age≈39.9 years) were equally randomized to the oral and topical TXA group. One patient in the topical group discontinued treatment due to sensitivity, while all in the oral group completed the study. At baseline, MASI scores were not significantly different between the two groups (p = 0.28). After 12 weeks, both groups demonstrated significant reductions in MASI scores (oral group: 58.86%; topical group: 50.88%; p = 0.001 for each), though the difference was insignificant. DISCUSSION: Fifty female patients (mean age≈39.9 years) were equally randomized to the oral and topical TXA groups. One patient in the topical group discontinued treatment due to sensitivity, while all in the oral group completed the study. Baseline MASI scores were similar (p = 0.28). After 12 weeks, both groups demonstrated significant reductions in MASI scores (oral group: 58.86%; topical group: 50.88%; p = 0.001 for each), though the difference was not statistically significant.

conclusionBoth forms of TXA are effective with low side effects. The choice between oral and topical TXA can depend on patient preference and convenience.