Comparative Evaluation of Topical Metformin and Topical Tranexamic Acid in Melasma

ConditionMelasma

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-50

SponsorFoundation University Islamabad

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18-50 years

Clinically diagnosed facial melasma

Both genders

Patients willing to give informed consent

Disqualifiers

• 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

Trial design

Design model

Parallel

Treatments tested in this trial

topical 3% tranexamic acid solution
Drug
nightly topical 3% tranexamic acid solution for 12 weeks with mineral sunscreen
Topical 30% metformin cream
Drug
Participants will apply topical 30% metformin once a night for 12 weeks, with concurrent use of mineral sunscreen.

Treatment groups

70 Participants

are divided into 2 treatment groups

Group A: Topical 3% tranexamic acid solutionActive comparator 1 intervention

Group B: topical 30% metfomin creamExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Mean reduction in MASI (MASI) score

Compare the mean reduction in MASI scores from baseline to 12 weeks between topical 30% metformin and 3% tranexamic acid.

Time frame

12 weeks

Secondary outcomes

Patients with adverse effects

Proportion of participants developing adverse effects (erythema, burning, peeling/dryness, or dyspigmentation) during treatment, compared between groups at follow-up visits.

Time frame

12 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Foundation University Islamabad

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: