Oral Metformin for Treating Melasma in Latin American Women
ConditionMelasma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age21+
SponsorUniversity of Puerto Rico
About this trial
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
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Metformin
DrugParticipants 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: MetforminExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (Week 0) to Week 12Sponsors and contacts
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Source ClinicalTrials.gov