Oral Metformin for Treating Melasma in Latin American Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Metformin.
- Who it may be relevant to
- Registry conditions: Melasma. Basic parameters: from 21 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Puerto Rico
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Oral Metformin in the Treatment of Melasma: a Prospective Trial in Latin American Women
Overview
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.
Interventions
- 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.
Primary outcome measures
- Change in modified Melasma Area and Severity Index (mMASI) score from baseline to week 12 [Time frame: Baseline (Week 0) to Week 12]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Puerto Rico · 1 center
- Administración de Servicios Médicos (ASEM) Clinicas Externas — San Juan
Identifiers
NCT: NCT06845540 · 2406248489