Efficacy and safety of Politranexamide® liposomal emulsion on facial melasma: A comparative study.

INTRODUCTION

Melasma is a human melanogenesis dysfunction that results in localized, chronic acquired hypermelanosis of the skin difficult to treat.

METHODS

This prospective, randomized, single-blind, study aimed to compare the efficacy and tolerability of a liposomal emulsion based on Politranexamide® (SAMPLE A) with that of a competitor based on acetylglucosamine, ethyl linoleate and phenyl ethyl resorcinol (SAMPLE B) in patients affected by facial melasma on 26 patients. Disease severity was assessed by the Melasma Area Severity Index (MASI) at baseline and after 6 and 12 weeks of therapy. All patients were subjected to photo documentation using DermaView camera and Antera 3D camera.

RESULTS

The mean MASI score at baseline was 10.93 ± 7 in the group A and 9.34 ± 6.29 in the group B, respectively. A significant decrease in MASI score from baseline was noted in both treatment groups as early as 6 weeks of follow-up (p = 0.00096 for SAMPLE A and p = 0.0049 for SAMPLE B) and was confirmed at the end of the treatment (p = 0.0006 for SAMPLE A and p = 0.00039 for SAMPLE B). Intergroup comparison revealed a greater improvement of melasma among patients in group A compared to those in group B that was quite statistically significant at weeks 6 (p = 0.055009) and significant after 12 weeks of follow-up (p = 0.032942). Both treatment groups experienced an improvement in Antera average level of melanin.

CONCLUSION

Our results suggested Politranexamide® to be a useful and safe therapeutic option in treating melasma, more effective than competitor used in this study.