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Comparative Evaluation of Topical Metformin and Topical Tranexamic Acid in Melasma
Sponsor: Foundation University Islamabad
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.
Official title: Comparative Evaluation of Topical Metformin and Topical Tranexamic Acid in Melasma Using MASI Score Reduction: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2026-07-01
Completion Date
2027-07-01
Last Updated
2026-03-27
Healthy Volunteers
No
Conditions
Interventions
topical 3% tranexamic acid solution
nightly topical 3% tranexamic acid solution for 12 weeks with mineral sunscreen
Topical 30% metformin cream
Participants will apply topical 30% metformin once a night for 12 weeks, with concurrent use of mineral sunscreen.
Locations (1)
Fauji Foundation Hospital, Rawalpindi
Rawalpindi, Punjab Province, Pakistan