NCT04687839已完成不适用
Assessment of the Wound Healing Efficacy and Tolerance of the Medical Device RL3010A DP0378 on a Blister Suction Model in Healthy Subjects.
Pierre Fabre Dermo Cosmetique2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2020年7月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Effect of the tested product on the wound healing at D6
研究概览
简要总结
The tested medical device is indicated for the treatment of wounds and small skin injuries. The intention of this study is to evaluate the tolerance and efficacy of the test product by measuring the recovery of the skin barrier after wound produced by suction blister. But also, by validating the accompanying physiological effect of the study product during this recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject with a phototype I, II or III according to the Fitzpatrick scale
- •Subject aged between 18 and 45 years included at selection visit
- •Subject with absence of infectious diseases (HIV and Hepatitis), confirmed by negative blood test results
排除标准
- •History of keloids and hypertrophic scars
- •Subject with removal of axillary lymph nodes
- •Pathology, active skin disease or dermatological condition in progress (psoriasis and/or lichen ruber and/or eczema ...) or presence of dermatological lesions on the inner side of the forearm (solar erythema or dermatosis ...) that may affect the performance of the research or judged incompatible with the realization of the study
- •Subject with severe illness (severe infectious disease (e.g. severe flu)), chronic disease or acute evolutionary pathology likely to influence the study results or considered by the investigator hazardous for the subject or incompatible with the study
- •Knowledge of Acquired Immunodeficiency Syndrome or Infectious (acute) Hepatitis
- •Subject presenting a healing pathology or a pathology with consequences on the healing like the diabetes mellitus (type I and type II)
- •Subject with congenital methemoglobinemia or porphyria
结局指标
主要结局
Effect of the tested product on the wound healing at D6
时间窗: Day6
By measuring the wound surface (measured by macro-photos) on treated area compared to an untreated area
次要结局
- Effect of the tested product on the cutaneous barrier restoration(Day1, Day2, Day4, Day6, Day8(+/-1), Day10(+/-1) and Day13(+/-1))
- Effect of the tested product on healing(Day1, Day2, Day4, Day6, Day8(+/-1), Day10(+/-1) and Day13(+/-1))
- Tolerance of the tested product(Day1, Day2, Day4, Day6, Day8(+/-1), Day10(+/-1) and Day13(+/-1))
研究者
研究点 (2)
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