Oral tranexamic acid with a triple combination cream versus oral tranexamic acid monotherapy in the treatment of severe melasma
Funding information
No funding source
Correction added on 22 June 2022, after first online publication: The word 'melisma' changed to 'Melasma' in the article title.
Abstract
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.
CONFLICT OF INTEREST
The authors have no conflict of interest to declare.
Open Research
DATA AVAILABILITY STATEMENT
The data that support the findings of this study are available from the corresponding author upon reasonable request.
