NCT00993005已完成3 期
Efficacy of CICATRIX (Asian Gotu Kola or Pennywort) in the Treatment of Hypertrophic Scars and Keloids Scars.
适应症
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
- 2
- 主要终点
- Length of the hypertrophic scar(s) and keloids measured by a millimetric ruler at week 12 (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 Hypertrophic scars and keloids. The duration of this double-blind placebo controlled phase 3 clinical trial will be 12 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
- •Hypertrophic wound or keloid with no treatment for more than 1 month.
- •Signed informed consent.
排除标准
- •Usage of steroids within 30 days.
- •Malignant neoplastic conditions.
- •Alcoholism.
- •Handicap and/or psychiatric condition preventing treatment accomplishment.
结局指标
主要结局
Length of the hypertrophic scar(s) and keloids measured by a millimetric ruler at week 12 (end of the treatment)
时间窗: 12 weeks
次要结局
- Occurrence of adverse effects at week 12 (end of the treatment)(12 weeks)
- Photographs of lesions at week 12 (end of the treatment)(12 weeks)
研究者
研究点 (2)
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