Evaluation of the Tolerance of Three Masks Under Dermatological Control.

Groupe Kolmi Hopen

Status: Completed

Conditions: Healthy Population

Treatments: Device: Investigational devices must be used 8 hours per day

Study type: Interventional

Funder types: Industry

Identifiers

NCT05193799

21E2022

Details and patient eligibility

About

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.

Enrollment: 98 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

98 participants in 3 patient groups

Investigational device#1 = Kolmi® Op-AirTM KALM

Experimental group

Treatment:

Device: Investigational devices must be used 8 hours per day

Investigational device#2 = Kolmi® Op-Air OneTM

Experimental group

Treatment:

Device: Investigational devices must be used 8 hours per day

Investigatonal device#3 = Kolmi® Op Air-Pro® Oxygen

Experimental group

Treatment:

Device: Investigational devices must be used 8 hours per day