RESUMO
Background: Melasma is a widespread condition that affects people of many ethnicities and is prevalent in the Middle East. To date, the therapeutic arsenal is still not effective, especially in countries with high ultraviolet light index. New treatment options are needed. Objective: The aim of this pilot study was to assess the efficacy of topical tranexamic acid (TA) 2% combined with vitamin C 2% in the treatment of resistant melasma in the Mediterranean region. Methods: This prospective interventional pilot study included 10 women, aged 18 to 55 years, with resistant melasma. Intervention consisted in application of a topical formulation containing 2% TA and 2% vitamin C, every night for eight weeks. The primary outcome was the Melasma Area and Severity Index (MASI) score measured at baseline and at Weeks 4 and 8. Melasma Quality of Life Scale (MelasQoL) and Physician Global Assessment (PGA) were used at baseline and at Weeks 4 and 8 of treatment, and they were set as the secondary outcomes. Results: The mean MASI score varied from 12.76±3.91 at baseline to 7.00±4.85 at Week 4 (p<0.01) then to 3.39 ± 1 at Week 8 (p=0.03). The mean MelasQoL decreased from 35.2 ± 16.03 at baseline to 28.8 ± 12.96 at Week 4 (p<0.01) then to 24.9±13.96 at Week 8 (p=0.14). The PGA increased between Weeks 4 and 8 passing from 2.2±0.79 to 2.4±1.07. No major side effects were reported. Conclusion: Our pilot study demonstrated the possibility of a topical combination of TA 2% and vitamin C 2 %, which may be a useful therapeutic strategy in the treatment of resistant melasma in the Middle east, a region of the world with high UV index. This combination treatment is a safer alternative to dangerous bleaching treatments that are still being used.
