NCT01736969Unknown不适用
Microcyn Scar Management HydroGel, K103163 vs. Kelo-cote® Scar Gel for the Management of Hypertrophic or Keloid Scars
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Comparison between groups in Vancouver Scar Scale total score from Baseline to Day 112 (or early termination)
研究概览
简要总结
The purpose of this study is to determine whether a developmental formulation is substantially equivalent to the predicate device in the treatment of hypertrophic and keloid scars.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide informed consent and release health information
- •Ability to follow study instructions and study requirements
- •Have a hypertrophic or keloid scar accessible for treatment and evaluation
- •Negative pregnancy test for women of childbearing potential
- •Agreement to use effective birth control method for study duration
排除标准
- •History of allergy or sensitivity to components
- •History of diabetes
- •History of collagen vascular disorders
- •Anticipated need for surgery or hospitalization during the study
- •Pregnant, nursing, or planning a pregnancy during the study
- •Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to Baseline (Day 0)
结局指标
主要结局
Comparison between groups in Vancouver Scar Scale total score from Baseline to Day 112 (or early termination)
时间窗: 4 weeks, 8 weeks, 12 weeks
Vascularity, height/thickness, pliability, and pigmentation. Scoring from zero to thirteen.
次要结局
- Pain and itch(4 weeks, 8 weeks, 12 weeks)
- Adverse Events(Baseline, Weeks: 2, 4, 8, 12 and early termination)
- Treatment satisfaction(8 weeks, 12 weeks)
研究者
研究点 (2)
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