Comparative Evaluation of Topical Metformin and Topical Tranexamic Acid in Melasma

Starting soon · Not applicable

Conditions studied: Melasma

In brief

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.

Key facts

Study ID: NCT07495748
Run by: Foundation University Islamabad
People needed: 70
Starts: 2026-07-01
Expected to finish: 2027-07-01
Last updated by the study team: 2026-03-27

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients aged 18-50 years
Clinically diagnosed facial melasma
Both genders
Patients willing to give informed consent

You may not qualify if…

• Pregnant or lactating women
Patients using systemic or topical melasma treatments in the previous 4 weeks
Known hypersensitivity to study medications
Presence of other facial dermatoses
History of photosensitivity disorders

Where it is running

Fauji Foundation Hospital, Rawalpindi — Rawalpindi, Punjab Province, Pakistan

Full record on ClinicalTrials.gov

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