NCT03878433已完成不适用
Oral Superoxide Dismutase (GLISODin) to Decrease Melasma Severity. A Prospective Randomized Placebo-controlled Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Severity of melasma
研究概览
简要总结
Oxidative stress has been reported to play a role in melasma pathophysiology. The objective of the study is to compare oral superoxide dismutase (GLISODin) to placebo, in combination to sunscreen to decrease melasma severity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed melasma in adult patient
- •signed inform consent
排除标准
- •Pregnant women
- •Other pigmentary disorder of the afce
- •Use of depigmentant agent in the month before the inclusion
- •Use of topical steroid, tretinoin, hydroquinone in the month before the inclusion
- •Coeliac disease or allergy to gluten
研究组 & 干预措施
Drug
Active Comparator
Glisodin : 2 capsules of GliSODin, 500mg of GliSODIn per day. Preferably to take in the morning during breakfast
干预措施: Glisodin (Drug)
No Drug
Placebo Comparator
2 capsules of PLacebo, 500mg of Placebo per day. Preferably to take in the morning during breakfastbo
干预措施: placebo (Other)
结局指标
主要结局
Severity of melasma
时间窗: At baseline and at 12 weeks
Change from Baseline of the Modified Melasma Area and Severity Index (mMASI) total score at 12 months. The MASI is 0 à 24 : Front 0.3(D)(A)+ right malar 0.30(D)(A)+ left malar 0.30(D)(A)+ chin 0.1(D)(A)
次要结局
- Satisfaction of the patients: VAS (Visual Analog Scale)(At baseline and at 12 weeks)
- Quality of life of patient: VAS (Visual Analog Scale)(At baseline and at 12 weeks)
研究者
研究点 (1)
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