A Randomized Comparative Study of Intralesional Tranexemic Acid and Kligman's Regimen in Indian Patients with Melasma.

CONTEXT: Melasma is an acquired chronic disorder of hyperpigmentation. Tranexamic acid (TXA) has been shown to be effective in reducing the severity of melasma.

AIMS: The aim of this study is to compare the efficacy of intralesional TXA with topical Kligman's regimen in the treatment of facial melasma and to assess their safety profile.

SETTINGS AND DESIGN: A double arm open-labeled randomized controlled trial was conducted at a tertiary care center in western India.

MATERIALS AND METHODS: Sixty-eight cases of facial melasma of either sex and age ≥ 18 years were randomized into two groups. Group A received intradermal injections of TXA 4 mg/mL, whereas group B received topical Kligman's therapy. Patients were evaluated at baseline, 4th, 8th, and 12th week semi-objectively using modified melasma area severity index (mMASI) score, physician's global assessment scale, and patient's global assessment scale.

STATISTICAL ANALYSIS: Data were analyzed using SPSS v16 software. Mann-Whitney U -test, Friedman's analysis of variance test, and Pearson's χ2 test were used. P -value less than 0.05 was considered as statistically significant.

RESULTS: Fifty-nine patients completed the study. The decrease in mean mMASI score was statistically significant at 4th, 8th, and 12th week for both groups. On intergroup comparison, a statistically significant difference was observed between both the groups at 12th week ( P < 0.01), with group B showing better response to therapy but no difference at baseline and at 4th and 8th week. Group A showed no significant side effects, whereas group B showed erythema, burning, and hypopigmentation in nine, six, and three patients, respectively.

CONCLUSION: Kligman's regimen remains the gold standard for melasma but with multiple serious adverse effects. Intralesional TXA is a safe and promising modality in the treatment of melasma. It can be used in non-responding cases and in those who develop side effects of Kligman's regimen.