Comparative Evaluation of Topical Metformin and Topical Tranexamic Acid in Melasma

Summary

This randomised controlled trial aims to compare the efficacy of topical metformin (30%) and topical tranexamic acid (3%) in the treatment of melasma using reduction in the Melasma Area and Severity Index (MASI) score over 12 weeks. Melasma is a common hyperpigmentation disorder with significant cosmetic and psychological impact, and current treatments often have limitations. Both metformin and tranexamic acid have shown promising depigmenting effects through different mechanisms. A total of 70 patients will be enrolled and randomly divided into two groups. Participants will apply the assigned treatment once daily along with sunscreen and will be assessed at baseline and at 4, 8, and 12 weeks. The primary outcome is MASI score reduction, while secondary outcomes include patient-reported improvement and safety. This study seeks to provide comparative evidence for safer and more effective treatment options for melasma management.

Timeline

Start

2026-07-01

Primary completion

2026-12-01

Completion

2027-07-01

Publications

• Background Al Mohammady A, Kadah AS, Mahran MA, Elsaie ML. Microneedling-assisted delivery of metformin versus tranexamic acid in treating melasma: a randomized controlled study. Eur J Med Res. 2025 Aug 18;30(1):761. doi: 10.1186/s40001-025-03032-1.
• Background Banavase Channakeshavaiah R, Andanooru Chandrappa NK. Topical metformin in the treatment of melasma: A preliminary clinical trial. J Cosmet Dermatol. 2020 May;19(5):1161-1164. doi: 10.1111/jocd.13145. Epub 2019 Sep 10.
• Background Suliman RS, Alhuwayshil J, Almuflehi AA, Al Zaghir AK, Alateqi HA, Mohamedin HE, Mohammed AE, Alghamdi SS. Emerging topical therapies for melasma: a comparative analysis of efficacy and safety. J Dermatolog Treat. 2025 Dec;36(1):2591502. doi: 10.1080/09546634.2025.2591502. Epub 2025 Nov 27.
• Background Jiang J, Akinseye O, Tovar-Garza A, Pandya AG. The effect of melasma on self-esteem: A pilot study. Int J Womens Dermatol. 2017 Dec 8;4(1):38-42. doi: 10.1016/j.ijwd.2017.11.003. eCollection 2018 Mar.

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Indications