Healthy PopulationNCT05193799
Evaluation of the Tolerance of Three Masks Under Dermatological Control.
A study testing Investigational devices must be used 8 hours per day in people with Healthy Population, run by Groupe Kolmi Hopen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Population
- What is being tested?
- Investigational devices must be used 8 hours per day
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jan 2022to 17 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy Population
- Being tested
- Investigational devices must be used 8 hours per day
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational devices must be used 8 hours per dayDevice
During 3 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Investigational device#1 = Kolmi® Op-AirTM KALM | Experimental | Not described Receives: Device: Investigational devices must be used 8 hours per day |
| Investigational device#2 = Kolmi® Op-Air OneTM | Experimental | Not described Receives: Device: Investigational devices must be used 8 hours per day |
| Investigatonal device#3 = Kolmi® Op Air-Pro® Oxygen | Experimental | Not described Receives: Device: Investigational devices must be used 8 hours per day |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Days 3
Secondary outcomes (2)
Subjective appreciation
Analysis of the subject's answer to a subjective evaluation questionnaire
Measured: 3 days
Number of Adverse event
Collection of cutaneous and systemic Adverse Event
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start3 Jan 2022
- Primary completion17 Feb 2022
- Study completion17 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy PopulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Kolmi Hopen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Siham Rharbaoui, Principal investigator, Eurofins Dermscan Pharmascan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05193799
- Sponsor's protocol ID
- 21E2022
- Status last verified
- Mar 2022
- First submitted
- 22 Dec 2021
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocentric, Open Study for the Evaluation of the Tolerance of Three Class I Medical Devices Under Dermatological Control.
- ClinicalTrials.gov ID
- NCT05193799
- Acronym / sponsor ID
- 21E2022
- Conditions
- Healthy Population
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Groupe Kolmi HopenIndustry (pharma, biotech, devices)
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 17 Feb 2022 (actual)
- Study completion
- 17 Feb 2022 (actual)
- First posted
- 18 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational devices must be used 8 hours per dayDuring 3 consecutive days | Device | Investigational device#1 = Kolmi® Op-AirTM KALM, Investigational device#2 = Kolmi® Op-Air OneTM, Investigatonal device#3 = Kolmi® Op Air-Pro® Oxygen |
Primary outcome
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
2 secondary outcomes
Subjective appreciation
Time frame: 3 days
Number of Adverse event
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siham Rharbaoui principal investigator
Eurofins Dermscan Pharmascan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational devices must be used 8 hours per day in people with Healthy Population, run by Groupe Kolmi Hopen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cutaneous tolerance (time frame: Days 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.