A first RCT of oral tranexamic acid for the management of patients with melasma has found twice daily treatment reduces lesional erythema.
A small Melbourne study randomised 17 patients with moderate to severe melasma to either oral tranexamic acid (25mg twice daily) or placebo for 12 weeks. All patients also applied daily SPF 50+ sunscreen for a period of 24 weeks.
The study found that the median erythema index decreased in both the treated and control groups from baseline to the end of treatment at 12 weeks (138 to 96; 128 to 96) but regressed over the following 12 weeks of follow-up.
While the difference in erythema index between the two groups was not significantly different at 12 or 24 weeks, the magnitude of the change from baseline was significantly different over both time periods (47 v 16 at 12 weeks ; 31 v 14 at 24 weeks).
“In 5 out of 7 participants in the tranexamic acid group, there was a noticeable objective change in pigmentations and erythema from baseline to week 12 as seen in clinical photographs,” the study said.
There were no visible improvements in melasma for participants on placebo.
The treatment appeared to be well tolerated with no serious adverse events reported.
“After tranexamic acid treatment was ceased at 12 weeks, further follow-up at 24 weeks demonstrated that the results were not completely maintained though the tranexamic acid group still showed greater reduction of erythema index compared to placebo.”
“The relapsing nature and transient effects of tranexamic acid for melasma have been shown with varying outcomes in other studies.”
The investigators, led by Dr Jennifer Nguyen from the Victorian Melanoma Service at Alfred Health, noted that other studies with topical and injectable tranexamic acid had found no significant change in erythema index.
“Despite our small sample size, we present encouraging early results that oral tranexamic acid alone improves lesional erythema in melasma, which is a key component of melasma pathogenesis,” they concluded.
“However, the effects of oral tranexamic acid on erythema index are not likely to be completely maintained following cessation of therapy. Further larger studies with longer follow-up will be needed to confirm our findings.”
The study was published in the Australasian Journal of Dermatology.