Melasma
Conditions
Keywords
melasma, metformin
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.
Interventions
DRUGMetformin
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.
Sponsors
University of Puerto Rico
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in modified Melasma Area and Severity Index (mMASI) score from baseline to week 12 | 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. |
Countries
Puerto Rico
Contacts
Primary ContactCristina Brau
Backup ContactCamila Cordero
Outcome results
None listed