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Completed

NCT Number: NCT05193799

Evaluation of the Tolerance of Three Masks 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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laboratoire Eurofins Dermscan Pharmascan

Villeurbanne, 69100, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • 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;

Treatment and study plan

Investigational devices must be used 8 hours per day

Device

During 3 consecutive days

Primary outcomes

  1. 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

Secondary outcomes

  1. Subjective appreciation

    Time frame: 3 days

    Analysis of the subject's answer to a subjective evaluation questionnaire

  2. Number of Adverse event

    Time frame: 3 days

    Collection of cutaneous and systemic Adverse Event

Sponsors and collaborators

Lead sponsor

Groupe Kolmi Hopen

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 18, 2022
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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