Recruiting

NCT Number: NCT06845540

Oral Metformin for Treating Melasma in Latin American Women

The goal of this clinical trial is to learn if metformin can treat melasma in Latin American women. The main question it aims to answer is:

- Can metformin help reduce the dark patches of melasma?

Researchers will test two different doses of metformin (500 mg and 1000 mg) to see if either one helps improve melasma.

Participants will:

* Take a metformin pill every day for three months. * Go to the clinic twice: once at the beginning and once at the end of the study. * Get a phone call from the researchers to check how they're doing and ask about any changes or side effects.

Recruiting

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Key information

Conditions

Melasma Hyperpigmentation Melanosis Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Administración de Servicios Médicos (ASEM) Clinicas Externas

San Juan, PR, 00935, Puerto Rico

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Latin American women aged 21 years or older, diagnosed epidermal or mixed melasma

Exclusion criteria

pregnancy, breastfeeding, use of hydroquinone or tretinoin within 2 months before the study, or undergoing laser treatment, peels, microdermabrasion, or microneedling within 2 months of the study. Patients with a history of renal or liver disease, metformin allergy, diabetes, hypoglycemia, or those on medications that could interact with metformin will also be excluded.

Treatment and study plan

metformin

Drug

Participants received oral metformin tablets for the treatment of melasma. The initial dose was 500 mg once daily for four weeks. At week 4, participants who tolerated the medication well increased their dose to 500 mg twice daily for the remaining eight weeks of the study. Participants were instructed to avoid other melasma treatments during the trial and to use sunscreen (SPF 30 or higher) daily.

Primary outcomes

Change in modified Melasma Area and Severity Index (mMASI) score from baseline to week 12

Time frame: Baseline (Week 0) to Week 12

The primary outcome measure will be the change in melasma severity as assessed by the modified Melasma Area and Severity Index (mMASI) score. The mMASI score will be recorded at baseline (week 0) and at the end of the study (week 12). A blinded investigator will evaluate the participants' melasma severity using this validated scoring system, with a lower mMASI score indicating improvement in melasma.

Study contacts

Contact information is provided by the study sponsor or research team.

Camila Cordero

CONTACT

[email protected]

Cristina Brau

CONTACT

[email protected]

787-758-2525 ext. 5500

Sponsors and collaborators

Lead sponsor

University of Puerto Rico

Other

Registry information

Official study title

Oral Metformin in the Treatment of Melasma: a Prospective Trial in Latin American Women

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Feb 25, 2025
Registry last updated: Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting