Systemic SclerosisNCT03644225
Suction Based Characterization of Healthy and Diseased Skin
A study testing Measurment with Aspirational Medical Device and Measurment with Cutometer MPA 580 in people with Systemic Sclerosis, run by Oliver Distler at 1 site in Switzerland.
Trial summary
The mechanical properties of healthy and SSc-diseased skin will be assessed by suction based measurements. The negative pressure needed to gain a certain tissue elevation, tissue elevation in response to a certain negative pressure as well as the time of retraction of tissue will be recorded and analyzed. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- Measurment with Aspirational Medical Device and Measurment with Cutometer MPA 580
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteSwitzerland
- Study dates
- 11 Jun 2018to 4 Jun 2019
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -Signed Informed Consent
- Healthy volunteers:
- Age ≥18 years old
- SSc-Patients:
- Age ≥18 years old
- Diagnosis of systemic sclerosis according to the ACR/EULAR 2013 criteria
- Skin thickening diagnosed by clinical expert
Who cannot join
- Known or suspected non-compliance, drug or alcohol abuse,
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- Previous enrolment into the current study,
- Participants, who are unable to hold still
- Impaired skin at the regions of measurements
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Rheumatology, University Hospital Zurich
Zurich, 8091
About this study
Official title: Mechanical Characterization of Healthy and Diseased Skin With Suction Based Assessment of Skin Deformability
The mechanical properties of healthy and SSc-diseased skin will be assessed by suction based measurements. The negative pressure needed to gain a certain tissue elevation, tissue elevation in response to a certain negative pressure as well as the time of retraction of tissue will be recorded and analyzed. Mesurments will be done with the new developed Aspiration Device_Nimble and with the CE-certified Cutometer MPA 580.
Read the detailed description
Patients with systemic sclerosis (SSc) show a thickening of the skin due to massive deposition of collagen and temporary edema in the dermis. The clinical palpation method is currently the only diagnosis method. For an objective detection a non-invasive skin elasticity measurement can be performed. The widely used approach is based on local tissue suction. This study aims at an identification and quantification of mechanical and structural properties of human skin. The results will then be compared in age- and gender matched control groups. For evaluation of the skin elasticity measurement the results will be compared to the clinical parametar validated, modified Rodnan skin score (mRSS).
The mechanical properties of healthy and diseased skin will be assessed by suction based measurements. The negative pressure is needed to gain a certain tissue elevation. Tissue elevation in response to a certain negative pressure as well as the time of retraction of tissue will be recorded and analyzed. (The different parameters depend on
- Conditions
- Systemic Sclerosis
- Being tested
- Measurment with Aspirational Medical Device, Measurment with Cutometer MPA 580
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurment with Aspirational Medical DeviceDevice
The mechanical properties of healthy and SSc-diseased skin will be assessed by suction based measurements with a new developed Aspirational Medical Device.
Measurment with Cutometer MPA 580Device
The mechanical properties of healthy and SSc-diseased skin will be assessed by CE-marked Cutometer MPA 580
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control | Other | Healthy controls, who signed an informed consent, age ≥18 years old will be age and sex matched to the SSc patients Receives: Device: Measurment with Aspirational Medical Device; Device: Measurment with Cutometer MPA 580 |
| Systemic sclerosis patients | Other | SSc patients who signed an Informed consent
* Age ≥18 years old
* Diagnosis of systemic sclerosis according to the ACR/EULAR 2013 criteria
* Skin thickening diagnosed by clinical expert Receives: Device: Measurment with Aspirational Medical Device; Device: Measurment with Cutometer MPA 580 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical characterization of healthy and diseased skin using novel aspiration device and comparing it to the already validated Cutometer® MPA 580.
The stiffness (mbar/mm) properties of healthy skin and SSc skin will be measured with the Aspiration Device and the Cutometer MPA 580. For comparison of different locations on the body, back of the hand (left and right) and dorsal forearm (left and right) will be assessed for every participant at one time point (Visite 1).
Measured: one visit, one measurement, one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start11 Jun 2018
- Primary completion4 Jun 2019
- Study completion4 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic SclerosisStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Primary outcome: Mechanical characterization of healthy and diseased skin using novel aspiration device and comparing it to the already validated Cutometer® MPA 580. Comparison of mechanical skin properties of healthy to patients' skin tissue (control vs. examined group). Secondary outcome: Defining predictors of the skin worsening.
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oliver Distler
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Federal Institute of Technology
- Responsible party
- Sponsor-investigator, Oliver Distler, University of Zurich
- Investigators
- Oliver Distler, Prof.Dr.med, Principal investigator, Department of Rheumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03644225
- Sponsor's protocol ID
- Swissmedic:2017-MD_0045
- Other IDs
- 2017-01154, 2017
- Status last verified
- May 2023
- First submitted
- 4 May 2018
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Muller B, Ruby L, Jordan S, Rominger MB, Mazza E, Distler O. Validation of the suction device Nimble for the assessment of skin fibrosis in systemic sclerosis. Arthritis Res Ther. 2020 Jun 3;22(1):128. doi: 10.1186/s13075-020-02214-y.
PubMed 32493508
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Characterization of Healthy and Diseased Skin With Suction Based Assessment of Skin Deformability
- ClinicalTrials.gov ID
- NCT03644225
- Acronym / sponsor ID
- Swissmedic:2017-MD_0045
- Conditions
- Systemic Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Oliver DistlerUniversity, hospital or other
- Collaborators
- Swiss Federal Institute of Technology
- Study start
- 11 Jun 2018 (actual)
- Primary completion
- 4 Jun 2019 (actual)
- Study completion
- 4 Jun 2019 (actual)
- First posted
- 23 Aug 2018 (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 mechanical properties of healthy and SSc-diseased skin will be assessed by suction based measurements. The negative pressure needed to gain a certain tissue elevation, tissue elevation in response to a certain negative pressure as well as the time of retraction of tissue will be recorded and analyzed. Mesurments will be done with the new developed Aspiration Device_Nimble and with the CE-certified Cutometer MPA 580.
Detailed description
Patients with systemic sclerosis (SSc) show a thickening of the skin due to massive deposition of collagen and temporary edema in the dermis. The clinical palpation method is currently the only diagnosis method. For an objective detection a non-invasive skin elasticity measurement can be performed. The widely used approach is based on local tissue suction. This study aims at an identification and quantification of mechanical and structural properties of human skin. The results will then be compared in age- and gender matched control groups. For evaluation of the skin elasticity measurement the results will be compared to the clinical parametar validated, modified Rodnan skin score (mRSS).
The mechanical properties of healthy and diseased skin will be assessed by suction based measurements. The negative pressure is needed to gain a certain tissue elevation. Tissue elevation in response to a certain negative pressure as well as the time of retraction of tissue will be recorded and analyzed. (The different parameters depend on
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Primary outcome: Mechanical characterization of healthy and diseased skin using novel aspiration device and comparing it to the already validated Cutometer® MPA 580. Comparison of mechanical skin properties of healthy to patients' skin tissue (control vs. examined group). Secondary outcome: Defining predictors of the skin worsening.
| Arm | Type | Receives |
|---|---|---|
| Healthy Control | Other | Device: Measurment with Aspirational Medical Device, Device: Measurment with Cutometer MPA 580Healthy controls, who signed an informed consent, age ≥18 years old will be age and sex matched to the SSc patients |
| Systemic sclerosis patients | Other | Device: Measurment with Aspirational Medical Device, Device: Measurment with Cutometer MPA 580SSc patients who signed an Informed consent * Age ≥18 years old * Diagnosis of systemic sclerosis according to the ACR/EULAR 2013 criteria * Skin thickening diagnosed by clinical expert |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- -Signed Informed Consent
- Age ≥18 years old
- Age ≥18 years old
- Diagnosis of systemic sclerosis according to the ACR/EULAR 2013 criteria
- Skin thickening diagnosed by clinical expert
Key exclusion criteria (5 listed)
- Known or suspected non-compliance, drug or alcohol abuse,
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- Previous enrolment into the current study,
- Participants, who are unable to hold still
- Impaired skin at the regions of measurements
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 |
|---|---|---|
| Measurment with Aspirational Medical DeviceThe mechanical properties of healthy and SSc-diseased skin will be assessed by suction based measurements with a new developed Aspirational Medical Device. | Device | Healthy Control, Systemic sclerosis patients |
| Measurment with Cutometer MPA 580The mechanical properties of healthy and SSc-diseased skin will be assessed by CE-marked Cutometer MPA 580 | Device | Healthy Control, Systemic sclerosis patients |
Primary outcome
Mechanical characterization of healthy and diseased skin using novel aspiration device and comparing it to the already validated Cutometer® MPA 580.
Time frame: one visit, one measurement, one year
The stiffness (mbar/mm) properties of healthy skin and SSc skin will be measured with the Aspiration Device and the Cutometer MPA 580. For comparison of different locations on the body, back of the hand (left and right) and dorsal forearm (left and right) will be assessed for every participant at one time point (Visite 1).
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 9 May 2023.
- Derived from this study: PubMed 32493508Muller B, Ruby L, Jordan S, Rominger MB, Mazza E, Distler O. Validation of the suction device Nimble for the assessment of skin fibrosis in systemic sclerosis. Arthritis Res Ther. 2020 Jun 3;22(1):128. doi: 10.1186/s13075-020-02214-y.
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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.
Oliver Distler, Prof.Dr.med principal investigator
Department of Rheumatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurment with Aspirational Medical Device and Measurment with Cutometer MPA 580 in people with Systemic Sclerosis, run by Oliver Distler at 1 site in Switzerland.
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 7 inclusion and 5 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 9 May 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 Switzerland. 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?
Mechanical characterization of healthy and diseased skin using novel aspiration device and comparing it to the already validated Cutometer® MPA 580. (time frame: one visit, one measurement, one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03644225, which also lists 1 linked publication.
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 9 May 2023.