Oral Metformin for Treating Melasma in Latin American Women
NCT ID: NCT06845540
Last Updated: 2025-02-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2025-02-20
2025-05-30
Brief Summary
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\- 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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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.
21 Years
FEMALE
No
Sponsors
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University of Puerto Rico
OTHER
Responsible Party
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Cristina Brau-Javier
MD, Associate Professor
Principal Investigators
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Cristina Brau
Role: PRINCIPAL_INVESTIGATOR
University of Puerto Rico
Locations
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Administración de Servicios Médicos (ASEM) Clinicas Externas
San Juan, PR, Puerto Rico
Countries
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Central Contacts
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Other Identifiers
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2406248489
Identifier Type: -
Identifier Source: org_study_id
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