Clinical evaluation of efficacy and tolerability of cysteamine 5% cream in comparison with tranexamic acid mesotherapy in subjects with melasma: a single-blind, randomized clinical trial study

This study was aimed at evaluating the efficacy of Tranexamic Acid (TA) mesotherapy versus cysteamine 5% cream in the treatment of melasma. This single-blind, randomized clinical trial was conducted among 54 subjects between 2018 and 2019. Cysteamine 5% cream group was instructed to apply the cream on the melasma lesions 30 min before bed for 4 consecutive months. Conversely, 0.05 mL (4 mg/mL) TA mesotherapy was performed by a physician every 4 weeks until 2 months. The severity of melasma was evaluated using both Dermacatch (R) device and the modified Melasma Area Severity Index (mMASI). The most remarkable improvement rate was observed in the TA group at the third visit based on mMASI and Dermacatch (R) values at 47% and 15% in turn. The mMASI scores were substantially improved in both groups at the second visit (cysteamine vs TA 8.48 +/- 2.34 and 7.03 +/- 3.19;P = 0.359) and third visit (cysteamine vs TA 6.32 +/- 2.11 and 5.52 +/- 2.55;P = 0.952) as compared to baseline (cysteamine vs TA: 11.68 +/- 2.70 and 10.43 +/- 2.69). Dermacatch (R) values were significantly declined at the second and third visits (cysteamine vs TA 42.54 +/- 12.84 and 38.75 +/- 9.80,P = 0.365; 40.74 +/- 12.61 and 36.17 +/- 10.3,P = 0.123, respectively) compared with baseline (cysteamine vs TA 45.76 +/- 13.41 and 42.41 +/- 10.48), although the improvement rates between two groups were not significantly different. Findings suggest that none of the cysteamine and TA mesotherapy treatments measured by both mMASI and Dermacatch (R) methods have substantial advantages over the other; however, complications are less in the cysteamine than the TA mesotherapy group.