Effects of Masks Containing 0.5% Tranexamic Acid-Loaded Ethosomes on Melasma in the Asian Skin: A Randomized Controlled Clinical Trial

Abstract

Background. Tranexamic acid (TA) has emerged as a promising treatment for melasma without serious adverse effects. Ethosomes have been reported as the carriers for transdermal drug delivery systems to increase the amount of drug permeation through the skin. However, few studies of the local usage of TA-loaded ethosomes exist. Objectives. To evaluate the efficacy of a mask containing 0.5% TA-loaded ethosomes in the treatment of melasma in the Asian skin. Methods. In a double-blind, placebo-controlled, randomized, prospective study, 88 Asian participants with melasma were randomized 1 : 1 to two groups as follows: the TA or control. The TA group was treated with moisturizing masks with 0.5% TA-loaded ethosomes, and the control was treated with moisturizing masks only. Masks were applied once daily for the first two weeks and once every other day for the third and fourth weeks. The primary outcome was measured by the modified melasma area and severity index (mMASI) and a visual analog scale (VAS) for vessels. The secondary outcomes were VAS for skin texture and satisfaction. Results. The reduction of VAS vessel scores at the end of treatment in the TA group was significantly greater than that in the control group $\left(P<0.001\right)$ . The mMASI scores and skin texture scores decreased over time in both groups, but no significant differences were found between the two groups $\left(P>0.05\right)$ . The score of participant satisfaction in the TA group was significantly higher than that in the control group $\left(P<0.01\right)$ . Conclusions. Masks containing TA-loaded ethosomes appear to be an effective treatment for Asian melasma in terms of angiogenesis and skin texture. It improves the pigmentation to some extent but has no significance. This trial is registered with ChiCTR1900024257.