Randomized, placebo-controlled, double-blind study of oral tranexamic acid in the treatment of moderate to severe melasma

Publication date: Available online 4 October 2017
Source:Journal of the American Academy of Dermatology
Author(s): Eunice Del Rosario, Stephanie Florez- Pollack, Lucio Zapata, Katia Hernandez, Andrea Tovar-Garza, Michelle Rodrigues, Linda S. Hynan, Amit G. Pandya
BackgroundMelasma is a common pigmentary disorder that is often difficult to treat. Tranexamic acid (TA) has emerged as a promising treatment for melasma; however, few controlled studies exist.ObjectiveTo determine the efficacy of oral TA in patients with moderate to severe melasmaMethodsPatients with moderate to severe melasma were treated with 250 mg of TA or placebo capsules twice daily for 3 months and sunscreen followed by 3 months of treatment with sunscreen only. The primary outcome measure was the modified Melasma Area and Severity Index (mMASI) score.Results44 patients were enrolled and 39 completed the study. At 3 months, there was a 49% reduction in mMASI score in the TA group vs. 18% in the control group. Patients with severe melasma improved more than those with moderate melasma. Three months after stopping treatment, there was a 26% reduction in mMASI in the TA group compared to the baseline visit versus a 19% reduction in the placebo arm. No serious adverse events were noted in either group.LimitationsSingle center study enrolling predominantly Hispanic womenConclusionsOral TA appears to be an effective treatment for moderate to severe melasma with minimal side effects.