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

Department of Dermatology, University of Texas Southwestern Medical Center, Dallas, Texas. Department of Dermatology, St. Vincent's Hospital, Melbourne, Victoria, Australia; The Skin and Cancer Foundation Inc, Melbourne, Victoria, Australia; The Royal Children's Hospital, Melbourne, Victoria, Australia. Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, Texas; Department of Biostatistics, University of Texas Southwestern Medical Center, Dallas, Texas; Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, Texas. Department of Dermatology, University of Texas Southwestern Medical Center, Dallas, Texas. Electronic address: amit.pandya@utsouthwestern.edu.

Journal of the American Academy of Dermatology. 2018;78(2):363-369
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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.
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Language : eng
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine