of patients from a public dermatology clinic in Brazil.
“Our study was one of the few to compare the use of oral TA isolated against a control group using a placebo and to evaluate the results by four different methods,” wrote lead author Mariana Morais Tavares Colferai, MD, of the Universidade de Mogi das Cruzes (Brazil), and her coauthors. The study was published online in the Journal of Cosmetic Dermatology.TA is a plasmin inhibitor, first described as a treatment for melasma in 1979. It is approved in the United States for treating menorrhagia.
In the randomized, double-blind, controlled trial of 47 patients with facial melasma – 37 completed the study – participants were assigned to one of two groups: Group A received 250 mg of tranexamic acid twice daily (n = 20) while group B received a placebo twice daily (n = 17). All patients were advised to use sunscreen. Before treatment and after 12 weeks, the researchers evaluated patients with four methods: the Melasma Area Severity Index (MASI), photographic records, patient evaluation with questionnaire (MELASQoL), and colorimetry assessed via a colorimeter.
Per evaluation of all tests, melasma improved in 50% of patients in group A, compared with 5.9% of patients in group B (P less than .005). Group A saw improvements in the mean MASI score (20.9 at pretreatment vs. 10.8 after treatment, P less than .001), mean MELASQoL value (55.4 vs. 38.2, P less than .001), and colorimetry (55.0 vs. 56.1, with higher values indicating lighter pigmentation, P = .033).
The most common side effects among those who received TA were gastrointestinal effects, such as nausea and diarrhea (5%); changes in menstrual flow (10%); and headache (14%). No serious side effects were reported.
The authors acknowledged several potential limitations in their study, including a lack of intermediate evaluations between pretreatment and 12 weeks. They also noted that the photographs were dichotomously classified as either “yes for improvement” or “no for the lack of improvement or worsening,” which may “limit the accuracy of our results” for that particular method.
The tranexamic acid and placebo for the study was provided by U.SK Dermatology/Brazil. No conflicts of interest were reported.
SOURCE: Colferai MMT et al. J Cosmet Dermatol. 2018 Dec 9. doi: 10.1111/jocd.12830.