Evaluation of the Tolerance of Three Masks Under Dermatological Control.

Not Applicable

Completed

• Conditions: Healthy Population
• Interventions: Device: Investigational devices must be used 8 hours per day

• Registration Number: NCT05193799
• Lead Sponsor: Groupe Kolmi Hopen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-22
• Study Start: 2022-01-03
• Study First Submitted QC: 2022-01-14
• Study First Posted: 2022-01-18
• Primary Completion: 2022-02-17
• Study Completion: 2022-02-17
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-01
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

1. Healthy Subject;
2. Sex: male or female ;
3. Age: more than 18 years ;
4. Phototype: I to IV on the Fitzpatrick scale;
5. 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).
6. 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.
7. Subject having given freely and expressly his/her informed consent;
8. For subjects randomized to group 3: Fit test FFP on M52014-WH

Exclusion Criteria

In terms of population

1. Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship;

2. Subject in a social or sanitary establishment;

3. Subject suspected to be non-compliant according to the investigator's judgment;

4. Subject enrolled in another clinical trial or which exclusion period is not over.

5. Subject majors under curatorship, safeguard of justice, activated future protection mandate or family authorization In terms of associated pathology

6. Subject with a condition or receiving a medication which, in the investigator's judgment, put the subject at undue risk;

7. Subject suffering from a severe or progressive disease.

8. 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.

9. Subject' who is allergic to one or several component of the studied devices. Relating to previous or ongoing treatment

10. 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;

11. Subject having started or changed any hormonal treatment during the three previous months.

    In terms of lifestyle

12. Intensive exposure to sunlight or UV-rays within the previous month and/or foreseen during the study;

13. Subject planning to change her/his life habits during the study;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Investigational device#1 = Kolmi® Op-AirTM KALM	Investigational devices must be used 8 hours per day	-
Investigational device#2 = Kolmi® Op-Air OneTM	Investigational devices must be used 8 hours per day	-
Investigatonal device#3 = Kolmi® Op Air-Pro® Oxygen	Investigational devices must be used 8 hours per day	-

Primary Outcome Measures

Name	Time	Method
Cutaneous tolerance	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

Secondary Outcome Measures

Name	Time	Method
Subjective appreciation	3 days	Analysis of the subject's answer to a subjective evaluation questionnaire
Number of Adverse event	3 days	Collection of cutaneous and systemic Adverse Event

Trial Locations

Locations (1)

Laboratoire Eurofins Dermscan Pharmascan; 🇫🇷 Villeurbanne, France