Randomized, double-blind, placebo-controlled split-face trial of the efficacy of tranexamic acid by drug delivery through microneedling in the treatment of melasma.

Background: Melasma is a prevalent skin pigmentation disorder that is difficult to treat. Tranexamic acid (TA) is a potential agent, but there are few studies on its effectiveness under the transdermal route (drug delivery-Dd). One of these Dd pathways is through microneedling, which seems to be effective itself.

Objective: To evaluate the efficacy of tranexamic acid when applied in the form of drug delivery through microneedling in the treatment of facial melasma.

Methods: A randomized controlled double-blind split-face trial with 3 monthly sessions in 20 melasma patients: microneedling was performed in the entire face, and then TA solution was applied to one hemiface and placebo to the other. The effectiveness was measured using Hemi-MASI (Melasma Area and Severity Index), images pixels, and perceptions of experts and patients.

Results: Hemi-MASI regressed 22% in control and 29% in TA side. A good/better improvement was found in 37.5% of the control and 42.5% of TA by the experts and 60% of the patients for both sides. Pixels increased by 5 and 7, respectively. In none of these criteria, there was a significant difference between the sides.

Conclusion: Tranexamic acid in drug delivery through microneedling did not bring additional benefit to the treatment of melisma.