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

Journal of the American Academy of Dermatology Oct 09, 2017

Rosario ED, et al. - This trial substantiated the efficacy of oral tranexamic acid (TA) in patients with moderate to severe melasma. The inference drawn was that oral TA was an effective therapy for moderate to severe melasma with minimal side effects.

Methods

  • As a part of this study individuals with moderate to severe melasma were treated with 250 mg of TA or placebo capsules twice daily for 3 months along with sunscreen treatment, followed by 3 months of treatment with sunscreen only.
  • The modified Melasma Area and Severity Index (mMASI) score served as the primary outcome measure.

Results

  • The enrollment comprised of 44 patients.
  • 39 patients completed the study.
  • 49% reduction was noted in mMASI score in the TA group vs. 18% in the control group, at 3 months.
  • Patients with severe melasma displayed a greater improvement than those with moderate melasma.
  • 26% reduction was illustrated in mMASI in the TA group than the baseline visit versus a 19% reduction in the placebo arm, 3 months after discontinuing the treatment.
  • Neither of the group demonstrated any serious adverse events.

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