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

Eunice Del Rosario, Stephanie Florez-Pollack, Lucio Zapata, Katia Hernandez, Andrea Tovar-Garza, Michelle Rodrigues, Linda S. Hynan, Amit G. Pandya

Research output: Contribution to journalArticlepeer-review

35 Scopus citations

Abstract

Background: Melasma 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. Objective: To determine the efficacy of oral TA in patients with moderate-to-severe melasma. Methods: Patients 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. Results: A total of 44 patients were enrolled and 39 completed the study. At 3 months, there was a 49% reduction in mMASI score in the TA group versus 18% in the control group. Patients with severe melasma improved more than those with moderate melasma. Three months after treatment was stopped, there was a 26% reduction in mMASI score in the TA group compared with the baseline visit versus a 19% reduction in the placebo arm. No serious adverse events were noted in either group. Limitations: Single-center study enrolling predominantly Hispanic women. Conclusions: Oral TA appears to be an effective treatment for moderate-to-severe melasma with minimal side effects.

Original languageEnglish (US)
Pages (from-to)363-369
Number of pages7
JournalJournal of the American Academy of Dermatology
Volume78
Issue number2
DOIs
StatePublished - Feb 2018

Keywords

  • Hispanic
  • evidence-based medicine
  • melanin
  • melasma
  • pigmentation
  • randomized controlled trial
  • tranexamic acid

ASJC Scopus subject areas

  • Dermatology

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