MelasmaPhase 1/2NCT06845540
Oral Metformin for Treating Melasma in Latin American Women
A Phase 1/2 study testing Metformin in people with Melasma, run by University of Puerto Rico at 1 site in Puerto Rico.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Melasma
- What is being tested?
- Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePuerto Rico
- Study dates
- 20 Feb 2025to 30 May 2025
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Camila Cordero contact
Puerto Rico1 site, 1 recruiting
- Recruiting
Administración de Servicios Médicos (ASEM) Clinicas Externas
San Juan, PR, 00935
About this study
Official title: Oral Metformin in the Treatment of Melasma: a Prospective Trial in Latin American Women
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Week 0) to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start20 Feb 2025 (estimated)
- Primary completion22 May 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelasmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Puerto Rico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina Brau-Javier, University of Puerto Rico
- Investigators
- Cristina Brau, Principal investigator, University of Puerto Rico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06845540
- Sponsor's protocol ID
- 2406248489
- Status last verified
- Feb 2025
- First submitted
- 19 Feb 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Metformin in the Treatment of Melasma: a Prospective Trial in Latin American Women
- ClinicalTrials.gov ID
- NCT06845540
- Acronym / sponsor ID
- 2406248489
- Conditions
- Melasma
- Keywords
- melasma, metformin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Puerto RicoUniversity, hospital or other
- Study start
- 20 Feb 2025 (estimated)
- Primary completion
- 22 May 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metformin | Experimental | Drug: MetforminParticipants 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminParticipants 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. | Drug | Metformin |
Primary outcome
Change in modified Melasma Area and Severity Index (mMASI) score from baseline to week 12
Time frame: Baseline (Week 0) 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Melasma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Camila Cordero contact
Cristina Brau principal investigator
University of Puerto Rico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Metformin in people with Melasma, run by University of Puerto Rico at 1 site in Puerto Rico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cristina Brau (787-758-2525 ext. 5500, cbrau@skinbybrau.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in modified Melasma Area and Severity Index (mMASI) score from baseline to week 12 (time frame: Baseline (Week 0) to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.