NCT05193799已完成不适用
Monocentric, Open Study for the Evaluation of the Tolerance of Three Class I Medical Devices Under Dermatological Control.
Groupe Kolmi Hopen2 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2022年1月3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
- 98
- 试验地点
- 2
- 主要终点
- Cutaneous tolerance
研究概览
简要总结
This is a monocentric, open and randomized study. The purpose is to evaluate the cutaneous tolerance of three medical masks (class I medical device) after 3 consecutive days of use on a population with normal or sensitive skin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Subject;
- •Sex: male or female ;
- •Age: more than 18 years ;
- •Phototype: I to IV on the Fitzpatrick scale;
- •For half of the population in each group : subject presenting a sensitive skin on the face confirmed by an interrogatory with the investigator (see Appendix 19.1).
- •Subjects who did not use any new cosmetic product on the face in the past 30 days and who agree not to change them during the study period.
- •Subject having given freely and expressly his/her informed consent;
- •For subjects randomized to group 3: Fit test FFP on M52014-WH
排除标准
- •In terms of population
- •Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship;
- •Subject in a social or sanitary establishment;
- •Subject suspected to be non-compliant according to the investigator's judgment;
- •Subject enrolled in another clinical trial or which exclusion period is not over.
- •Subject majors under curatorship, safeguard of justice, activated future protection mandate or family authorization In terms of associated pathology
- •Subject with a condition or receiving a medication which, in the investigator's judgment, put the subject at undue risk;
- •Subject suffering from a severe or progressive disease.
- •Subject's with too many hairs, bears,(to put above) skin lesions, skin disease or severe acne on the face that could interfere with the tolerance evaluation.
- •Subject' who is allergic to one or several component of the studied devices. Relating to previous or ongoing treatment
- •Subject undergoing a topical treatment on the test area or a systemic treatment:
- •anti-inflammatory medication and/or antihistamines during the 2 weeks prior to screening and during the study;
- •corticosteroids during the 2 weeks and prior to screening and during the study;
- •retinoids and/or immunosuppressors during the 3 months prior to screening and during the study;
- •Subject having started or changed any hormonal treatment during the three previous months.
- •In terms of lifestyle
- •Intensive exposure to sunlight or UV-rays within the previous month and/or foreseen during the study;
- •Subject planning to change her/his life habits during the study;
结局指标
主要结局
Cutaneous tolerance
时间窗: Days 3
Evaluation of the percentage of subjects presenting no relevant clinical or functional signs of cutaneous intolerance after 3 days of use of the three medical devices
次要结局
- Subjective appreciation(3 days)
- Number of Adverse event(3 days)
研究者
研究点 (2)
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