Evaluation of the Tolerance of Three Masks Under Dermatological Control.

NCT05193799 | Completed

• 1 other identifier: 21E2022
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Population

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Subjective appreciation

  3 days

• Number of Adverse event

  3 days

Study Arms (3)

Investigational device#1 = Kolmi® Op-AirTM KALM

EXPERIMENTAL

Device: Investigational devices must be used 8 hours per day

Investigational device#2 = Kolmi® Op-Air OneTM

EXPERIMENTAL

Device: Investigational devices must be used 8 hours per day

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

EXPERIMENTAL

Device: Investigational devices must be used 8 hours per day

Interventions

Investigational devices must be used 8 hours per day DEVICE

During 3 consecutive days

Investigational device#1 = Kolmi® Op-AirTM KALM; Investigational device#2 = Kolmi® Op-Air OneTM; Investigatonal device#3 = Kolmi® Op Air-Pro® Oxygen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Groupe Kolmi Hopen: lead

Study Sites (1)

Laboratoire Eurofins Dermscan Pharmascan

Villeurbanne, 69100, France

Location

Study Officials

• Siham Rharbaoui

  Eurofins Dermscan Pharmascan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: January 18, 2022
• Study Start: January 3, 2022
• Primary Completion: February 17, 2022
• Study Completion: February 17, 2022
• Last Updated: March 2, 2022

Record last verified: 2022-03

Locations

FR (1)