COMPARATIVE STUDY OF EFFICACY AND SAFETY OF ORAL TRANEXAMIC ACID WITH TOPICAL TRIPLE COMBINATION VERSUS TRIPLE COMBINATION ALONE IN MELASMA

Objective: Melasma is a chronic acquired hyper melanosis of skin, involving sun exposure areas of the face and neck. Even with various treatment modalities, melasma recurs and long-term treatment is associated with many side effects. Tranexamic acid, the antifibrinolytic agent is a drug of research for melasma, as it inhibits melanogenesis. Hence, the present study compares the efficacy and safety of oral Tranexamic acid (TXA) with topical Triple Combination Cream (TCC) containing fluticasone propionate 0.05%, tretinoin 0.025% and hydroquinone 2% versus topical triple combination alone in the treatment of melasma. Methods: About 120patients who met the inclusion criteria were randomly assigned into two groups of 60 patients each. Group A was treated with TCC at night and group B received oral TXA 500mg once daily morning and TCC at night for 8weeks. All patients were advised to apply sunscreen with SPF 50. The follow-up was done in the 4^th and 8^th week and MASI score (efficacy) and side effects if any, like deranged clotting time, bleeding time and ophthalmology examination (safety) were done. SPSS software was used for statistical analysis and categorical data was analyzed using the chi-square test and the Fischer-exact test. P-value <0.05 was considered significant. Results: Though TCC showed a good response in the 8th week, the TCC+TXA group had a faster, better and more sustained rate of response in 4^th and 8^th weeks with highly significant results with p-values of <0.001 and <0.0001 respectively. Conclusion: TXA is an effective add-on in the treatment of melasma.