Oral Metformin for Treating Melasma in Latin American Women

NCT06845540 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 2406248489
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Melasma

Keywords

melasma; metformin

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Metformin

EXPERIMENTAL

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

Interventions

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.

Metformin

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Puerto Rico: lead

Study Sites (1)

Administración de Servicios Médicos (ASEM) Clinicas Externas

San Juan, PR, 00935, Puerto Rico

RECRUITING

MeSH Terms

Conditions

Melanosis

Interventions

Metformin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Cristina Brau

  University of Puerto Rico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristina Brau

CONTACT

787-758-2525; cbrau@skinbybrau.com

Camila Cordero

CONTACT

camila.cordero@upr.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Associate Professor

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 25, 2025
• Study Start: February 20, 2025
• Primary Completion: May 22, 2025
• Study Completion: May 30, 2025
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• 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.

Locations

PR (1)