Comparing Efficacy and Safety of Oral Tranexamic Acid and 4% Topical Hydroquinone Cream in Melasma Treatment: A Randomized Controlled Clinical Trial and Review of Literature

Abstract Introduction. Melasma is a common skin pigmentation disorder affecting a patient’s life psychologically and socially. Topical medications or lasers can have temporary and limited therapeutic effects on melasma. Material and Methods. This study is a prospective clinical trial comparing therapeutic effects of oral Tranexamic acid (TXA) and topical Hydroquinone (HQ) cream. A total number of 69 patients were examined. During the study, 10 patients failed to appear for the follow-up and 59 of them completed the trial. The patients were also divided randomly into two groups. Group A received TXA capsule 250 mg every 12 hours and group B received 4% topical HQ cream day and night. The patients from both groups were treated for 3 months. Melasma Area and Severity Index (MASI) scores were then calculated at the baseline, 4 weeks, and 12 weeks into the treatment and 3 months after the end of intervention. Results . MASI baseline, 4 weeks,12 weeks, and 24 weeks in TXA group were 21.66, 13.69, 9.10, 9.24; respectively. Reduction of MASI between baseline and 4 weeks was statistically significant. Such a decreasing trend in MASI scores between baseline and 12 weeks was also reported as statistically significant (p=0.001). In the HQ group, MASI baseline,4 weeks, 12 weeks, and 24 weeks were 21.46, 13.57, 10.93, 11.20; respectively. Reduction of MASI scores between baseline and 4 weeks was statistically significant. Moreover, a decline in MASI scores was observed between baseline and 12 weeks that was statistically significant (p=0.001). Considering both groups MASI scores were reduced but the difference between two study groups was not statistically significant (p=0.98). Conclusion. The efficacy of TXA and HQ was the same and both could significantly reduce MASI scores.