Oral Metformin in the Treatment of Melasma: a Prospective Trial in Latin American Women
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in modified Melasma Area and Severity Index (mMASI) score from baseline to week 12
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Latin American women aged 21 years or older, diagnosed epidermal or mixed melasma
排除标准
- •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.
研究组 & 干预措施
Metformin
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.
干预措施: Metformin (Drug)
结局指标
主要结局
Change in modified Melasma Area and Severity Index (mMASI) score from baseline to week 12
时间窗: 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.
次要结局
未报告次要终点
研究者
Cristina Brau-Javier
MD, Associate Professor
University of Puerto Rico