Oral tranexamic acid as adjuvant in melasma: A boon or bane!!!

Introduction: Tranexamic acid,antifibrinolytic and a plasmin inhibitor is a new armament in melasma management. Objectives: To compare the safety and efficacy of combination of oral tranexamic acid(TXA) and topical fluocinolone-based combination cream(FbTC) with that of topical FbTC alone among melasma patients. Materials/Methods: In this two arm study,130 melasma patients attending our dermatology clinic were randomised using a computer software generated table into two blinded groups of 65 patients each after valid consent, relevant history and examination. Ethical clearance was obtained.Group A patients received kits containing oral TXA 250 mg bd + topical FbTC while group B was given kit containing oral placebo + FbTC. Patients in both groups were advised to use kits for 12 weeks. Recurrence was evaluated 3 months after stopping therapy at week 24.Standard sunscreen was given in both groups for 24 weeks.Patients were evaluated at baseline, week 4,8,12 and 24 semiobjectively using modified melasma area severity index(mMASI), Visual analogue Scale(VAS) and Patient's Global Assessment(PtGA).Data was analyzed using SPSS software. Results: Results were analyzed in 120 patients who completed the study with 61 and 59 patients in group A and B respectively.Demographic profile with respect to age,gender,Fitzpatrick skin type, pattern,type and duration of melasma, mean mMASI was distributed equally in both groups. Marked improvement(>75%) in mMASI was seen in 8(13.1%),19(31.1%),40(65.6%),40(65.6%) patients in group A as compared to 1(1.7%),8(13.6%),16(27.1%),7(11.9%) patients in group B at end of 4th,8th,12th and 24th weeks respectively which was statistically significant(p<0.01).No major systemic adverse effects were noted in both groups.Recurrence was seen in 11(18.03%) in group A vs 38(64.4%) in group B at 24th week. Conclusion: Oral tranexamic acid could be used as an adjuvant to fluocinolone-based triple combination cream for a faster and sustained improvement in the melasma with low recurrence rate.