Status:
COMPLETED
Evaluation of the Tolerance of Three Masks Under Dermatological Control.
Lead Sponsor:
Groupe Kolmi Hopen
Conditions:
Healthy Population
Eligibility:
All Genders
18+ years
Phase:
NA
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 wit...
Eligibility Criteria
Inclusion
- 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
- 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:
- 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;
- 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;
Key Trial Info
Start Date :
January 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 17 2022
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT05193799
Start Date
January 3 2022
End Date
February 17 2022
Last Update
March 2 2022
Active Locations (1)
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1
Laboratoire Eurofins Dermscan Pharmascan
Villeurbanne, France, 69100