Unrecognized ConditionSKUMNCT04995549
SKin Uncertainties Modeling
A study testing Cutiscan® CS 100 in people with Unrecognized Condition, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
The study is based on measurement device and will provide a database of viscoelastic properties of the forearm skin among healthy volunteers. These data will be used to develop a mathematical model representative of the mechanical behavior of the skin. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Unrecognized Condition
- What is being tested?
- Cutiscan® CS 100
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 26 Nov 2021to 22 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers aged 18 to 50 years old
- non-opposition to participating in SKUM study
- Affiliation to french social security
Who cannot join
- Refusal to participate
- Volunteer with any skin disease likely to interfere with the primary outcome
- Legal incapacity or limited legal capacity
- Subject unlikely to cooperate with the study and / or weak cooperation
- Subject without health insurance
- Pregnant woman
- Subject being in the period of exclusion from another study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Construction of a Mechanical Data Base for Mathematically Modeling Uncertainties in Human Skin Tissues
The study is based on measurement device and will provide a database of viscoelastic properties of the forearm skin among healthy volunteers.
These data will be used to develop a mathematical model representative of the mechanical behavior of the skin.
- Conditions
- Unrecognized Condition
- Being tested
- Cutiscan® CS 100
- Keywords
- skin, non lesional, arm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cutiscan® CS 100Device
Repeated measures on healthy volunteers skin (forearm) are performed using Cutiscan® CS 100 device
| Study group | Role | What they receive |
|---|---|---|
| Measures using Cutiscan® CS 100 | Experimental | Not described Receives: Device: Cutiscan® CS 100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height of displacement (mm) of a skin disc.
The displacement will be obtained from repeated measures, on 30 volunteers, on forearm skin, and using Cutiscan® CS100 device. A database of skin viscoelasticity measure will be built from such data.
Measured: Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start26 Nov 2021
- Primary completion19 Jan 2022
- Study completion22 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unrecognized ConditionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brice CHATELAIN, MD, Principal investigator, CHU DE BESANCON
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04995549
- Sponsor's protocol ID
- 2020/527
- Acronym
- SKUM
- Status last verified
- Mar 2023
- First submitted
- 19 May 2021
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of a Mechanical Data Base for Mathematically Modeling Uncertainties in Human Skin Tissues
- ClinicalTrials.gov ID
- NCT04995549
- Acronym / sponsor ID
- SKUM / 2020/527
- Conditions
- Unrecognized Condition
- Keywords
- skin, non lesional, arm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 26 Nov 2021 (actual)
- Primary completion
- 19 Jan 2022 (actual)
- Study completion
- 22 Feb 2022 (actual)
- First posted
- 9 Aug 2021 (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.
The study is based on measurement device and will provide a database of viscoelastic properties of the forearm skin among healthy volunteers.
These data will be used to develop a mathematical model representative of the mechanical behavior of the skin.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Measures using Cutiscan® CS 100 | Experimental | Device: Cutiscan® CS 100 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy volunteers aged 18 to 50 years old
- non-opposition to participating in SKUM study
- Affiliation to french social security
Key exclusion criteria (7 listed)
- Refusal to participate
- Volunteer with any skin disease likely to interfere with the primary outcome
- Legal incapacity or limited legal capacity
- Subject unlikely to cooperate with the study and / or weak cooperation
- Subject without health insurance
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 |
|---|---|---|
| Cutiscan® CS 100Repeated measures on healthy volunteers skin (forearm) are performed using Cutiscan® CS 100 device | Device | Measures using Cutiscan® CS 100 |
Primary outcome
Height of displacement (mm) of a skin disc.
Time frame: Month 1
The displacement will be obtained from repeated measures, on 30 volunteers, on forearm skin, and using Cutiscan® CS100 device. A database of skin viscoelasticity measure will be built from such data.
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 21 Mar 2023.
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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.
Brice CHATELAIN, MD principal investigator
CHU DE BESANCON
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cutiscan® CS 100 in people with Unrecognized Condition, run by Centre Hospitalier Universitaire de Besancon 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 3 inclusion and 7 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 21 Mar 2023. 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?
Height of displacement (mm) of a skin disc. (time frame: Month 1). 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 21 Mar 2023.