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
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 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)
研究组 & 干预措施
RD047-023
Experimental
RD-047-023
干预措施: RD047-023 (Device)
Predicate Device
Active Comparator
legally marketed predicate device
干预措施: Predicate Device (Device)
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 (1)
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