A Randomized Controlled Study Comparing the Efficacy of Topical 5% Tranexamic Acid Solution versus 3% Hydroquinone Cream in Melasma

BACKGROUND AND AIMS: Melasma is a common, relapsing, acquired, symmetrical facial hypermelanosis with no universally effective therapy. Hydroquinone (HQ) is considered the gold standard in the treatment of melasma till date. Tranexamic acid (TA) is an upcoming molecule being explored in melasma therapy and has shown optimistic results in preliminary trials. This study aimed to compare the efficacy of topical 5% TA solution with 3% HQ cream in the treatment of melasma in Indian skin. MATERIAL AND METHODS: This was a prospective, randomized, single-blind study of 12 weeks’ duration. Hundred eligible patients randomly divided into two intervention groups were analyzed after screening 346 patients with melasma. Serial photographs, Melasma Area Severity Index (MASI), and adverse effects were documented at monthly intervals. Patient satisfaction score was noted at the end of 12 weeks. A repeated measurement analysis of variance, independent t-test, and χ(2) tests were used for statistical analysis. A P-value of <0.05 was considered to be statistically significant. RESULTS: Our study population consisted of 84 females and 16 males. Mixed melasma had the highest prevalence (63%) followed by epidermal (22%) and dermal types (15%). Percentage reduction of MASI was 27% and 26.7% in the TA and HQ group, respectively, at the end of 12 weeks, and the difference between the two groups was not significant (P > 0.05). However, patient satisfaction score was significantly higher in TA group (P value = 0.03) in view of lesser adverse effects. CONCLUSIONS: Topical 5% TA solution is as effective as 3% HQ cream in melasma with enhanced patient satisfaction.