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

J Am Acad Dermatol. 2018 Feb;78(2):363-369. doi: 10.1016/j.jaad.2017.09.053. Epub 2017 Oct 4.

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.

Keywords: Hispanic; evidence-based medicine; melanin; melasma; pigmentation; randomized controlled trial; tranexamic acid.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Administration, Oral
  • Adult
  • Antifibrinolytic Agents / administration & dosage
  • Antifibrinolytic Agents / therapeutic use*
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Humans
  • Melanosis / drug therapy*
  • Middle Aged
  • Severity of Illness Index
  • Sunscreening Agents / therapeutic use
  • Tranexamic Acid / administration & dosage
  • Tranexamic Acid / therapeutic use*

Substances

  • Antifibrinolytic Agents
  • Sunscreening Agents
  • Tranexamic Acid