Actively Recruiting

Phase 1
Phase 2
Age: 21Years +
FEMALE
ID06845540

Oral Metformin in the Treatment of Melasma: a Prospective Trial in Latin American Women

Led by University of Puerto Rico · Updated on 2025-02-25

30

Participants Needed

1

Research Sites

1 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating if metformin can help reduce the dark patches of melasma in Latin American women. This clinical trial aims to determine whether taking metformin daily for three months improves melasma, by comparing two different doses to see if either dose helps with this skin condition. The study is sponsored by the University of Puerto Rico and focuses on adult women aged 21 years and older. Participants will take oral metformin tablets starting at 500 mg once daily for the first four weeks. If participants tolerate the medication well, their dose will increase to 500 mg twice daily for the remaining eight weeks. During the trial, participants are asked to avoid other melasma treatments and use sunscreen with SPF 30 or higher daily. The study involves two clinic visits: one at the beginning and one at the end of the 12-week period. Throughout the study, researchers will monitor changes in the modified Melasma Area and Severity Index (mMASI) score from the start to week 12 to assess treatment impact. Participants will receive a phone call from the research team to check on their progress and any side effects. The total participation time spans three months, with evaluations at the start and conclusion of the treatment period.

CONDITIONS

Brief Title

Oral Metformin for Treating Melasma in Latin American Women

Who Can Participate

Age: 21Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Latin American women aged 21 years or older
  • Diagnosed with epidermal or mixed melasma
Not Eligible

You will not qualify if you...

  • Currently pregnant or breastfeeding
  • Use of hydroquinone or tretinoin within 2 months before the study
  • Undergoing laser treatment, chemical peels, microdermabrasion, or microneedling within 2 months before the study
  • History of renal or liver disease
  • Allergy to metformin
  • Diagnosis of diabetes or hypoglycemia
  • Taking medications that may interact with metformin

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 12 weeks

Participants receive oral metformin tablets, starting at 500 mg once daily for four weeks. At week 4, those who tolerate the medication increase to 500 mg twice daily for the remaining eight weeks. Participants are instructed to avoid other melasma treatments and to use sunscreen daily.

Trial Site Locations

Total: 1 location

1

Administración de Servicios Médicos (ASEM) Clinicas Externas

San Juan, PR, Puerto Rico, 00935

Actively Recruiting

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Research Team

C

Cristina Brau

C

Camila Cordero

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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