NCT06845540 Oral Metformin for Treating Melasma in Latin American Women
| NCT ID | NCT06845540 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University of Puerto Rico |
| Condition | Melasma |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-02-20 |
| Primary Completion | 2025-05-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2025-02-20 with a primary completion date of 2025-05-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Cristina Brau
PRINCIPAL INVESTIGATOR
University of Puerto Rico
Frequently Asked Questions
Who can join the NCT06845540 clinical trial?
This trial is open to female participants only, aged 21 Years or older, studying Melasma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06845540 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06845540 currently recruiting?
Yes, NCT06845540 is actively recruiting participants. Contact the research team at cbrau@skinbybrau.com for enrollment information.
Where is the NCT06845540 trial being conducted?
This trial is being conducted at San Juan, Puerto Rico.
Who is sponsoring the NCT06845540 clinical trial?
NCT06845540 is sponsored by University of Puerto Rico. The principal investigator is Cristina Brau at University of Puerto Rico. The trial plans to enroll 30 participants.