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

Groupe Kolmi Hopen1 site in 1 country98 target enrollmentJanuary 3, 2022

ConditionsHealthy Population

Overview

Phase: N/A
Intervention: Not specified
Conditions: Healthy Population
Sponsor: Groupe Kolmi Hopen
Enrollment: 98
Locations: 1
Primary Endpoint: Cutaneous tolerance
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 3, 2022

End Date

February 17, 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Groupe Kolmi Hopen

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

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

Outcomes

Primary Outcomes

Cutaneous tolerance

Time Frame: 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