Comparative Evaluation of Topical Metformin and Topical Tranexamic Acid in Melasma

NCT07495748 | Not Yet Recruiting

• 1 other identifier: FUMCRCT5
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Melasma

Keywords

Melasma; topical metformin; topical tranexamic acid; hyper-pigmentation; MASI

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (1)

• Patients with adverse effects

  12 weeks

Study Arms (2)

Topical 3% tranexamic acid solution

ACTIVE COMPARATOR

nightly tranexamic acid for 12 weeks with mineral sunscreen

Drug: topical 3% tranexamic acid solution

topical 30% metfomin cream

EXPERIMENTAL

Participants will apply topical 30% metformin cream, once nightly on the affected facial area for 12 weeks, with use of mineral sunscreen

Drug: Topical 30% metformin cream

Interventions

topical 3% tranexamic acid solution DRUG

nightly topical 3% tranexamic acid solution for 12 weeks with mineral sunscreen

Topical 3% tranexamic acid solution

Topical 30% metformin cream DRUG

Participants will apply topical 30% metformin once a night for 12 weeks, with concurrent use of mineral sunscreen.

topical 30% metfomin cream

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Foundation University Islamabad: lead

Study Sites (1)

Fauji Foundation Hospital, Rawalpindi

Rawalpindi, Punjab Province, 44000, Pakistan

Location

Related Publications (4)

• 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. PMID: 40826371; PMCID: PMC12359957

  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. PMID: 31502392.

  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. PMID: 41307217

  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. PMID: 29872675; PMCID: PMC5986109.

  BACKGROUND

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Dr. Bad e Harum, FCPS, Fellowship in Derma

CONTACT

+923335090999; harum_bade@yahoo.com

Dr. Arfan ul Bari, FCPS Derma

CONTACT

+923016547007; albariul@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The evaluating dermatologist, assessing MASI scores and photographs, will remain blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Topical 30% metformin cream and topical 3% tranexamic acid solution for 12 weeks

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 27, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)