Evaluation of the Tolerance of Three Masks Under Dermatological Control.

Monocentric, Open Study for the Evaluation of the Tolerance of Three Class I Medical Devices Under Dermatological Control.

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.

Study Overview

• Status: Completed
• Conditions: Healthy Population
• Intervention / Treatment: Device: Investigational devices must be used 8 hours per day

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Villeurbanne, France, 69100
    • Laboratoire Eurofins Dermscan Pharmascan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational device#1 = Kolmi® Op-AirTM KALM	Device: Investigational devices must be used 8 hours per day; During 3 consecutive days
Experimental: Investigational device#2 = Kolmi® Op-Air OneTM	Device: Investigational devices must be used 8 hours per day; During 3 consecutive days
Experimental: Investigatonal device#3 = Kolmi® Op Air-Pro® Oxygen	Device: Investigational devices must be used 8 hours per day; During 3 consecutive days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	3 days

Collaborators and Investigators

• Sponsor: Groupe Kolmi Hopen
• Investigators: Principal Investigator: Siham Rharbaoui, Eurofins Dermscan Pharmascan

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2022
• Primary Completion (Actual): February 17, 2022
• Study Completion (Actual): February 17, 2022

Study Registration Dates

• First Submitted: December 22, 2021
• First Submitted That Met QC Criteria: January 14, 2022
• First Posted (Actual): January 18, 2022

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: March 1, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 21E2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No