Authors Sadia Perveen, MD Alexandra Rubin MBS, et. al, compared the efficacy of combination therapy with oral tranexamic acid (TXA) and a fluocinolone-based triple combination cream (TCC) to the TCC cream alone in the treatment of melasma. Their findings, published in the Journal of Drugs in Dermatology (March 2022), showed that combination therapy was more effective.
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The researchers performed a single-center, randomized, controlled trial between June and December 2019 at the Benazir Bhutto hospital in Rawalpindi, Pakistan. Sixty total patients (56 females, 4 males) between the ages of 18 and 45 and of skin types III, IV and V were included. Of the 60 total patients, 30 were randomly assigned to receive a combination of oral TXA 250 mg along with fluocinolone-based TCC (treatment group). The other 30 patients were randomly assigned to receive only fluocinolone-based TCC (control group).
Patients applied the cream topically each night and washed their faces the next morning. They were also instructed to apply broad spectrum sunscreen daily. The severity of patients' melasma was assessed by the Melasma Area and Severity Index (MASI).
The primary endpoint of the study was the reduction in baseline MASI score at 8 weeks. MASI was recorded at baseline, 4-week and 8-week follow ups.
After 4 weeks of treatment, the MASI score decreased by an average of 39.9% in the treatment group compared to an average of 25.7% in the control group. After 8 weeks of treatment, the MASI score decreased by an average of 76.5% in the treatment group compared to an average decrease of 45.9% in the control group. All patients completed the study with no significant adverse effects being reported.
Both the treatment and control groups showed further reductions in MASI scores as treatment duration continued.