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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in modified Melasma Area and Severity Index (mMASI) score from baseline 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. | Baseline (Week 0) to Week 12 |
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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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cristina Brau | Contact | 787-758-2525 | 5500 | cbrau@skinbybrau.com |
| Camila Cordero | Contact | camila.cordero@upr.edu |
| Name | Affiliation | Role |
|---|---|---|
| Cristina Brau | University of Puerto Rico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Administración de Servicios Médicos (ASEM) Clinicas Externas | Recruiting | San Juan | PR | 00935 | Puerto Rico |
De-identified individual participant data (mMASI scores, Global Melasma Severity Assessment, and reported adverse events) will be shared with researchers upon request. Data will be available after study completion, pending approval from the principal investigator and institutional review board (IRB). Access will be granted through a secure repository or data-sharing agreement.
IPD and supporting information will be available starting 6 months after study completion. Data will be accessible for 5 years following publication of the primary study results.
De-identified individual participant data (mMASI scores, Global Melasma Severity Assessment scores, and reported adverse events) will be shared upon reasonable request. Access will be granted to qualified researchers affiliated with academic or healthcare institutions, subject to approval by the principal investigator and a data-sharing agreement. Requests should be submitted via email to the principal investigator, and approved researchers will receive access through a secure repository.
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| ID | Term |
|---|---|
| D008548 | Melanosis |
| ID | Term |
|---|---|
| D017495 | Hyperpigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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