Oral Metformin for Treating Melasma in Latin American Women

University of Puerto Rico (UPR)

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Melasma

Treatments: Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT06845540

2406248489

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Metformin

Experimental group

Description:

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.

Treatment:

Drug: Metformin