Resumen

Objectives: This updated systematic review and meta-analysis aimed to evaluate the efficacy and safety of tranexamic acid (TXA) in the treatment of melasma based on randomized controlled trials (RCTs). The analysis also compared the effectiveness of different routes of TXA administration and assessed associated adverse effects. Introduction: Melasma is a common acquired pigmentary disorder characterized by symmetric hyperpigmented macules and patches, primarily affecting sun-exposed areas and significantly impacting patients’ quality of life. Materials / method: In accordance with PROSPERO registration and PRISMA guidelines, a comprehensive literature search was conducted across four electronic databases to identify eligible RCTs evaluating TXA for melasma. Full-text English-language studies reporting standardized outcome measures were included, while studies with high risk of bias were excluded. Data from 22 RCTs were extracted and analyzed using RevMan software. Statistical heterogeneity was assessed using the I² statistic and forest plot analysis. Results: Twenty-two randomized controlled trials including 1,280 patients were analyzed. Tranexamic acid was administered orally, topically, or intradermally, with treatment durations ranging from 8 weeks to nearly 2 years. Overall, TXA significantly improved melasma severity, demonstrated by reductions in MASI, mMASI, MI, and hemi-MASI scores. Oral TXA showed the greatest reduction in MASI scores. Adverse effects were generally mild and included gastrointestinal discomfort, skin irritation, and menstrual irregularities. Conclusion: This updated analysis supports the efficacy of TXA as a therapeutic option for melasma, either as monotherapy or in combination with other treatments. Despite significant clinical improvement, variability in treatment protocols and outcome measures highlights the need for standardized dosing strategies and further long-term safety studies.