Oral tranexamic acid with a triple combination cream versus oral tranexamic acid monotherapy in the treatment of severe melasma.

BACKGROUND: Melasma is an acquired pigmentation disorder with a complex multifactorial etiopathogenesis. Oral tranexamic acid (TA) is a promising drug for its treatment and may enhance outcomes when used in combination. OBJECTIVE: To provide evidence of the efficacy and safety of oral TA as a monotherapy, and in combination with a triple combination cream, for treating melasma in the Hispanic population. METHODS: Forty-four female Hispanic patients with melasma were randomly assigned to receive 325 mg of oral TA every 12 h plus f-TCC (fluocinolone-based triple combination cream) every 24 h (group A) or 325 mg of oral TA every 12 h (group B) for 8 weeks, after which both groups were crossed-over, and treated for an additional 8 weeks. Evaluations of the mMASI score, the melanin index, and the MelasQoL were made at baseline and Weeks 4, 8, 12, and 16. RESULTS: There was a 50.04% and 65.45% improvement in mMASI at Weeks 4 and 8, respectively, in group A, compared to baseline, while for Week 16, an improvement of 76.85% was achieved in group B compared to baseline. Highest scores were consistent with the use of the combined treatment modality in both groups, and were evidenced by the values of the melanin index obtained. There was no significant difference in MelasQoL scores between the 2 groups. No serious side effects were observed. CONCLUSION: The combination of oral TA and f-TCC is more effective than oral TA alone in the treatment of severe melasma in Hispanic patients.

Evaluation of oral tranexamic acid in the treatment of melasma.

BACKGROUND: Melasma is an acquired, chronic, recurrent hypermelanosis that occurs exclusively in areas exposed to the sun. Its treatment can be very challenging. Tranexamic acid (TA) is an inhibitor of plasmin, and it is a synthetic derivative of the amino acid lysine that reversibly blocks binding sites on the plasminogen molecule, inhibiting the plasminogen activator from converting plasminogen to plasmin. AIMS: This study evaluated the efficacy of oral TA in the treatment of melasma in patients from a philanthropic dermatological clinic. PATIENTS/METHODS: This was a monocentric, randomized, double-blind, controlled clinical trial. Patients with facial melasma were randomly divided into the following two groups: A (TA 250 mg orally twice daily) or B (oral placebo twice daily). Evaluations were performed before and after 12 weeks of treatment with photographs, colorimetry, MELASQoL, and MASI. All patients were instructed to use tinted sunscreen (SPF 50). RESULTS: Of the 47 patients selected, 37 completed the study, with 20 in group A and 17 in group B; the patients consisted of one male and 36 females, and the mean age was 43.97 years old. Based on the four methods of evaluation, the melasma in 50% of patients in group A improved versus only 5.9% of patients in group B (P < 0.005). There was an improvement according to all evaluation methods in the treatment group. No patient had severe side effects. CONCLUSIONS: We conclude that tranexamic acid was effective in 50% of patients according to four methods of evaluation when compared to the placebo.