Oral Metformin for Treating Melasma in Latin American Women

Oral Metformin in the Treatment of Melasma: a Prospective Trial 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.

Study Overview

• Status: Recruiting
• Conditions: Melasma
• Intervention / Treatment: Drug: Metformin

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Cristina Brau; Phone Number: 5500 787-758-2525; Email: cbrau@skinbybrau.com
• Study Contact Backup: Name: Camila Cordero; Email: camila.cordero@upr.edu

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00935
    • Recruiting
    • Administración de Servicios Médicos (ASEM) Clinicas Externas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Metformin; Participants received oral metformin tablets, starting at 500 mg once daily. At week 4, those who tolerated the medication increased to 500 mg twice daily for the remainder of the study.

Drug: Metformin; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in modified Melasma Area and Severity Index (mMASI) score from baseline 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.	Baseline (Week 0) to Week 12

Collaborators and Investigators

• Sponsor: University of Puerto Rico
• Investigators: Principal Investigator: Cristina Brau, University of Puerto Rico

Study record dates

Study Major Dates

• Study Start (Estimated): February 20, 2025
• Primary Completion (Estimated): May 22, 2025
• Study Completion (Estimated): May 30, 2025

Study Registration Dates

• First Submitted: February 19, 2025
• First Submitted That Met QC Criteria: February 19, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 19, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: melasma; metformin
• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hyperpigmentation; Melanosis; Physiological Effects of Drugs; Hypoglycemic Agents; Metformin
• Other Study ID Numbers: 2406248489

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (mMASI scores, Global Melasma Severity Assessment, and reported adverse events) will be shared with researchers upon request. Data will be available after study completion, pending approval from the principal investigator and institutional review board (IRB). Access will be granted through a secure repository or data-sharing agreement.
• IPD Sharing Time Frame: IPD and supporting information will be available starting 6 months after study completion. Data will be accessible for 5 years following publication of the primary study results.
• IPD Sharing Access Criteria: De-identified individual participant data (mMASI scores, Global Melasma Severity Assessment scores, and reported adverse events) will be shared upon reasonable request. Access will be granted to qualified researchers affiliated with academic or healthcare institutions, subject to approval by the principal investigator and a data-sharing agreement. Requests should be submitted via email to the principal investigator, and approved researchers will receive access through a secure repository.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes