Phase 4 Study of Scarclinic™ Thin That Treats Surgical Scars.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change From Baseline in Vancouver Scar Scale Score(VSS) at 3 Months
研究概览
简要总结
Compare the efficacy and safety of Scarclinic™Thin and Scarclinic™ Normal for the treatment of surgical scars.
Participant: 40 Treatment period : 3 months Medical device: Scarclinic™Thin , Scarclinic™ Normal Randomization: Table of random number
详细描述
For evaluating the efficacy
- The investigator check Vancouver Scar Scale at 1 and 3 month after application to evaluate vascularity, pigmentation, elasticity, height, pain and itchiness
- The participant filled out survey included questions regarding convenience in use at 1 and 3 month after application.
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
- None
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
- •Patient who aged more than 18 years and less 55 years
- •Patient who has a surgical scar that is not over 3 months after the surgery
- •Patient who sign informed consent form for the study
排除标准
- •need wound dressing for exudate
- •wound infection
- •general malaise
- •history of mental disorders
- •taking anticancer drugs or antiphlogistics or steroid
结局指标
主要结局
Change From Baseline in Vancouver Scar Scale Score(VSS) at 3 Months
时间窗: Baseline and 3 months
Scar assessment will be performed at the beginning of the treatment, and at the end of the 3 month when the treatment is completed by using the Vancouver scar scale.VSS assesses 6 variables. * vascularity(range from normal(0 point) to purple(3point) * pigmentation(range from normal(0 point) to hyper-pigmentation(3point) * pliability(range from normal(0 point) to contracture(5point) * height (range from flat(0 point) to above 5mm(3point) * pain(range from none(0 point) to Require medication(2point) * itchiness(range from none(0 point) to Require medication(2point) We assess total score that are minimum score is 0 and maximum is 18. The lowest score means the best scar condition.
次要结局
- Satisfaction for Serviceability(the end of the 3 month of the treatment)
研究者
Chan-Yeong Heo
Assistant Professor
Seoul National University Hospital