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

Abstract

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. 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. Forty-four female Hispanic patients with melasma were randomly assigned to receive 325mg of oral TA every 12h plus f-TCC (fluocinolone-based triple combination cream) every 24h (group A) or 325mg of oral TA every 12h (group B) for 8weeks, after which both groups were crossed-over, and treated for an additional 8weeks. Evaluations of the mMASI score, the melanin index, and the MelasQoL were made at baseline and Weeks 4, 8, 12, and 16. 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 2groups. No serious side effects were observed. The combination of oral TA and f-TCC is more effective than oral TA alone in the treatment of severe melasma in Hispanic patients.