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. One-way 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.

Keywords

• antifibrinolytic
• hyperpigmentation
• microneedling