Efficacy of Tranexamic Acid Mesotherapy Using a Novel Device versus Topical Tranexamic Acid in Patients with Melasma: Protocol for a Randomised Clinical Trial

Abstract

Introduction: Melasma is a widely prevalent acquired condition characterised by gray-brown pigmentation with a predilection on the face, affecting the quality of life. Tranexamic Acid (TXA) has been used for managing melasma orally and topically, while mesotherapy is a well known modality in cosmetology. Need for the study: There is a paucity of literature comparing the efficacy of topical and intralesional microinjections of TXA. A novel device (Meso-Ice®) has recently been commercialised for mesotherapy, working on the principle of electroporation technology for drug diffusion, which has not yet been evaluated for managing melasma using TXA. Aim: To compare the efficacy of TXA mesotherapy using the novel device versus topical TXA in patients with melasma. Materials and Methods: This is a randomised clinical trial assessing the comparative efficacy of Group 1: Mesotherapy using the novel device with TXA injection (4 mg/mL) and Group 2: Topical TXA gel (3%) for treating melasma. The severity of melasma will be assessed using the Melasma Area and Severity Index (MASI) at baseline, four weeks, and eight weeks. Oneway Analysis of Variance (ANOVA) will be used to compare intra-group variables, and the paired t-test will be used for inter-group comparison. A p-value of <0.05 will be considered significant.