Oral Metformin for Treating Melasma in Latin American Women

Phase 1

Recruiting

• Conditions: Melasma
• Interventions: Drug: Metformin

• Registration Number: NCT06845540
• Lead Sponsor: University of Puerto Rico

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-19
• Study First Submitted QC: 2025-02-19
• Last Update Submitted: 2025-02-19
• Study Start: 2025-02-20
• Study First Posted: 2025-02-25
• Last Update Posted: 2025-02-25
• Primary Completion: 2025-05-22
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metformin	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Administración de Servicios Médicos (ASEM) Clinicas Externas; 🇵🇷 San Juan, Puerto Rico