CTRI/2024/07/070444尚未招募3 期
An interventional study to evaluate the efficacy and safety of topical metformin in the treatment of melasma at a tertiary care center
Anu Sarah Philip1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年7月22日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Percentage of patients with reduction in modified melasma area and severity index
研究概览
简要总结
This is an interventional study to evaluate the efficacy and safety of topical metformin cream once daily in treating 30 patients with melasma for 12 weeks that will be conducted in a single tertiary care centre in India. The primary outcome measure will be percentage of patients with reduction in modified melasma area and severity index score at 12 weeks . The secondary outcomes will be the percentage of patients with reduction in dermoscopy score and increase in patient satisfaction score at 12 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •ADULT MALES OR FEMALES WITH A CLINICAL DIAGNOSIS OF MELASMA.
排除标准
- •Age less than 18 years or more than 80 years.
- •Patients with a history of photosensitivity disorders.
- •Patients on medications known to cause hyperpigmentation or photosensitivity.
- •Patients on immunosuppressants .
- •Patients with facial pigmentation caused by conditions other than melasma.
结局指标
主要结局
Percentage of patients with reduction in modified melasma area and severity index
时间窗: 12 weeks
次要结局
- Percentage of patients with reduction in dermoscopy score(12 weeks)
- Percentage of patients with increase in patient satisfaction scale.(12 weeks)
研究者
Anu Sarah Philip
Bangalore Medical College and Research Institute
研究点 (1)
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