Efficacy and safety of tranexamic acid in the treatment of adult melasma: An updated meta-analysis of randomized controlled trials

Abstract

What is known and objective: Tranexamic acid (TXA) is a novel treatment option for melasma; however, no consensus exists on its use. This study evaluates the efficacy and safety of TXA for melasma. Methods: A comprehensive literature review was conducted to search for randomized controlled trials comparing TXA alone, TXA as adjuvant to routine treatment and placebo. Changes in the Melasma Area Severity Index (MASI)/modified MASI (mMASI) between pre- and post-treatment and between a certain melasma treatment and TXA were the primary outcomes. Twenty-four trials comparing oral, topical or intradermal TXA with routine treatment were included in the meta-analysis. Results and discussion: The change in MASI/mMASI scores at 4 (MD, 3.58; 95% confidence interval (CI), 2.15–5.01), 8 (MD, 5.08; 95% CI, 3.34–6.81), 12 (MD, 4.89; 95% CI, 3.80–5.97) and 16 (MD, 6.55; 95% CI, 2.62–10.48) weeks after treatment was all less than the baseline scores, regardless of the delivery route. The reduction in the MASI/mMASI scores between TXA adjuvant and routine treatment at 4 (MD, −0.43; 95% CI, −0.79 to −0.08), 8 (MD, −0.81; 95% CI, −1.09 to −0.54), 12 (MD, −1.10; 95% CI, −1.78 to −0.43) and 16 (MD, −1.12; 95% CI, −1.51 to −0.74) weeks was significant. However, the superiority of TXA was not detected when the topical or intradermal route was adopted. No serious adverse events occurred with the use of TXA. What is new and conclusion: These results suggest that oral TXA is an available, effective and safe alternative treatment for melasma.