NCT00991367已完成3 期
Efficacy of CICATRIX (Asian Gotu Kola or Pennywort) in the Treatment of Recent Post-surgical Scars
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Catalysis SL
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Length of the post-surgical scar(s) measured by a millimetric ruler at week 4 (end of the treatment)
研究概览
简要总结
The purpose of the study is to assess the efficacy of CICATRIX (Asian Gotu Kola or Pennywort) usage in the treatment of recent post-surgical scars. The duration of this double-blind placebo controlled phase 3 clinical trial will be 4 weeks. The estimated number of persons to be recruited and randomized for the study is 90.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recent (less than 48 hours) post-surgical wound
排除标准
- •Post-surgical wound with sepsis
- •Usage of steroids within 30 days
- •Malignant neoplastic conditions
- •Alcoholism
- •Handicap and/or psychiatric condition preventing treatment accomplishment.
研究组 & 干预措施
A
Experimental
Cicatrix
干预措施: Cicatrix (Other)
B
Placebo Comparator
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Length of the post-surgical scar(s) measured by a millimetric ruler at week 4 (end of the treatment)
时间窗: 4 weeks
次要结局
- Occurrence of adverse effects at week 4 (end of the treatment)(4 weeks)
- Photographs of lesions at week 4 (end of the treatment)(4 weeks)
研究者
研究点 (1)
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