Randomised, controlled, double‐blind study of combination therapy of oral tranexamic acid and topical hydroquinone in the treatment of melasma

Abstract

Background/Objectives: Melasma is a common pigmentary disorder for which oral tranexamic acid has shown some efficacy in previous studies. The aim of this study was to assess the effectiveness of oral tranexamic acid in combination with hydroquinone cream in the treatment of melasma. Methods: Subjects with moderate-to-severe melasma were enrolled. Group A received hydroquinone 4% cream, sunscreen and oral tranexamic acid, while Group B received hydroquinone 4% cream, sunscreen and placebo capsules for 3 months. All subjects had an additional 3-month follow-up visit on sunscreen alone. The primary outcome measure was change in modified Melasma Area and Severity Index (mMASI) score. In addition, the melanin index was measured using a mexameter. Results: Fifty subjects were enrolled, and all completed the study. There was a 55% reduction in mMASI after 3 months from mean 8.96 (SD 2.45) to 4.0 (SD 1.6) in Group A compared to 10.9% from mean 8.53 (SD 2.04) to 7.6 (SD 2.0) in Group B. Three months after oral and topical therapy was discontinued, there was a 42% decrease in mMASI compared to baseline in Group A (mean 5.1 SD 1.7) vs. 4.7% in Group B (mean 8.1 SD 2.0). No serious adverse events were observed. Conclusions: A combination of oral tranexamic acid and topical hydroquinone is more effective than hydroquinone alone in the treatment of melasma.

Comparison of 4% Topical Hydroquinone versus Combination of Oral Tranexamic Acid and 4% Topical Hydroquinone in the Treatment of Epidermal Melasma

“…There was a 42% reduction of mMASI as compared to baseline in Group A vs. 4.7% in Group B after 3 months of treatment. Results of this study was in favor of more effectiveness of combination of oral TXA with topical HQ as compared to topical HQ alone 23 similar to our study.…”

Efficacy and safety of tranexamic acid in the treatment of adult melasma: An updated meta‐analysis of randomized controlled trials

“…Among the 24 studies, 1383 patients were included. Eight studies [14][15][16][17][18][19][20][21] evaluated the efficacy and safety of oral TXA, four studies [22][23][24][25] evaluated the efficacy and safety of intradermal TXA, and twelve studies evaluated the efficacy and safety of topical TXA. 5,[26][27][28][29][30][31][32][33][34][35][36] In the study by Tawfic SO, 30 topical and intradermal TXA administration routes were adopted in the treatment arm; thus, the study was analysed separately.…”

“…We retrieved 86 studies from three databases, among which 24 studies published between 2013 and 2020 were finally eligible for inclusion 5,14–36 (Figure 1). Detailed information on the studies included is presented in Table 1.…”

A Review of Oral Therapies for the Treatment of Skin Hyperpigmentation

“…21 Shihab et al conducted a randomized, controlled, double-blind study of 50 Indonesian females with moderate or severe melasma which showed participants treated with 500 mg/day TXA and 4% hydroquinone cream had a more significant reduction in mMASI at 3 and 6 months than those treated only with 4% hydroquinone. 22 In a prospective, randomized controlled trial conducted in Nepal, 130 melasma patients were treated with 500 mg TXA daily in conjunction with routine topical hydroquinone and sunscreen for 3 months. When compared with those treated solely with routine topical measures, patients who also received oral TXA demonstrated a significantly lower mean MASI score at both 8 and 12 weeks.…”