Efficacy and safety of oral tranexamic acid as an adjuvant in Indian patients with melasma: a prospective, interventional, single‐centre, triple‐blind, randomized, placebo‐control, parallel group study

Abstract Background Melasma is a chronic recalcitrant pigmentary disorder whose treatment frustrates physician and patient alike. Tranexamic acid, a plasmin inhibitor, has demonstrated hypopigmenting properties. Aim To compare safety and efficacy of combination of oral tranexamic acid (TXA) and topical fluocinolone‐based combination cream (FbTC) with that of topical FbTC alone in melasma. Method One hundred and eighty patients patients of facial melasma of either sex attending dermatology OPD were screened. Consenting 130 participants were randomized into two blinded groups with 65 patients in each group. Group A patients received oral tranexamic acid 250 mg and oral ranitidine 150 mg twice daily and applied a triple combination cream containing fluocinolone acetonide 0.01%, tretinoin 0.05% and hydroquinone 2% once daily, and Group B was asked to take placebo tablets (calcium lactate and multivitamin) and apply the cream only for 12 weeks. Response was evaluated using modified melasma area severity index (mMASI) and graded mMASI improvement at 4th, 8th and 12th weeks, and at 24th week for recurrence. Data were analysed using SPSS software. Results Results were analysed in 120 patients who completed the study with 61 and 59 patients in group A and B, respectively. Demographic profile was equally distributed in both the groups. In group A, 13.1% patients showed marked improvement (>75%) in mMASI as compared to group B (1.7%) at 4th week. By 12th week, 65.6% patients had marked improvement in group A in contrast to only 27.1% in group B. At 24th week, group A (65.6%) had sustained improvement as compared to group B (11.9%) despite stopping treatment; all of which were statistically significant. Recurrence observed was 18.03% in group A vs. 64.4% in group B at 24th week. Conclusion Oral tranexamic acid is definitely a boon to the armamentarium of melasma management and should be used as an adjuvant to fluocinolone‐based triple combination cream for a faster, sustained improvement and to prevent recurrence.