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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational device#1 = Kolmi® Op-AirTM KALM | Experimental |
| |
| Investigational device#2 = Kolmi® Op-Air OneTM | Experimental |
| |
| Investigatonal device#3 = Kolmi® Op Air-Pro® Oxygen | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational devices must be used 8 hours per day | Device | During 3 consecutive days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cutaneous tolerance | 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 | Days 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective appreciation | Analysis of the subject's answer to a subjective evaluation questionnaire | 3 days |
| Number of Adverse event | Collection of cutaneous and systemic Adverse Event |
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Inclusion Criteria:
Exclusion Criteria:
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:
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;
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| Name | Affiliation | Role |
|---|---|---|
| Siham Rharbaoui | Eurofins Dermscan Pharmascan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratoire Eurofins Dermscan Pharmascan | Villeurbanne | 69100 | France |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 18, 2022 | |
| Reset | Jul 14, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 18, 2022 | Jul 14, 2023 |
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| 3 days |