The efficacy and safety of microneedling with topical tranexamic acid for melasma treatment: A systematic review and meta-analysis.

OBJECTIVE

Microneedling with topical tranexamic acid (TXA) is a novel treatment option for melasma; however, the efficacy and safety of this combined administration therapy is in controversial. This study is conducted to address this issue of this technique in melasma.

METHODS

An extensive literature review was performed to identify relevant trials, including randomized split-face studies, randomized controlled trials and prospective non-randomized split-face studies, comparing microneedling plus topical TXA to routine treatments or placebo. The primary outcomes were changes of the Melasma Area Severity Index (MASI)/modified MASI (mMASI)/hemi MASI between before and after treatment, as well as the changes between a particular treatment and microneedling plus TXA. The mean differences (MDs) and 95% confidence intervals (CIs) were calculated for the reduction of melasma severity scores from baseline to each time point. In contrast, the standard mean differences (SMDs) and 95% CIs were calculated for the differences in reduction in melasma severity scores between the experimental and control groups at each time point.

RESULTS

A total of 16 trials were included in the systematic review and data synthesis. The pooled analysis demonstrated that MASI, mMASI, and hemiMASI scores decreased significantly at 4 weeks (MD = 1.85; 95% CI = 1.15-2.54), 8 weeks (MD = 3.28; 95% CI = 2.31-4.24), 12 weeks (MD = 4.73; 95% CI = 2.79-6.50), 16 weeks (MD = 3.18; 95% CI = 1.50-4.85), and 20 weeks (MD = 3.20; 95% CI = 1.95-4.46) after treatment when compared with baseline. The reduction in melasma severity scores of microneedling with TXA group at 4 weeks was more significant than the routine treatment group (SMD = 0.97; 95% CI = 0.09-1.86), while insignificant at 8 weeks (SMD = 1.21; 95% CI = -0.17 to 2.59), 12 weeks (SMD = 0.63; 95% CI = -0.03 to 1.29), 16 weeks (SMD = 0.61; 95% CI = -2.85 to 4.07), or 20 weeks (SMD = 1.04; 95% CI = -1.28 to 3.36).

CONCLUSION

Despite the high heterogeneity across these studies, the current findings indicated that microneedling with topical TXA is an alternative treatment option for melasma treatment; and more well-designed studies are needed to confirm it.