Suction Based Characterization of Healthy and Diseased Skin
Primary Purpose
Systemic Sclerosis
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Measurment with Aspirational Medical Device
Measurment with Cutometer MPA 580
Sponsored by
About this trial
This is an interventional other trial for Systemic Sclerosis
Eligibility Criteria
Inclusion Criteria:
-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
Exclusion Criteria:
- 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
Sites / Locations
- Department of Rheumatology, University Hospital Zurich
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Healthy Control
Systemic sclerosis patients
Arm Description
Healthy controls, who signed an informed consent, age ≥18 years old will be age and sex matched to the SSc patients
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
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT03644225
First Posted
May 4, 2018
Last Updated
May 8, 2023
Sponsor
Oliver Distler
Collaborators
Swiss Federal Institute of Technology
1. Study Identification
Unique Protocol Identification Number
NCT03644225
Brief Title
Suction Based Characterization of Healthy and Diseased Skin
Official Title
Mechanical Characterization of Healthy and Diseased Skin With Suction Based Assessment of Skin Deformability
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 11, 2018 (Actual)
Primary Completion Date
June 4, 2019 (Actual)
Study Completion Date
June 4, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Oliver Distler
Collaborators
Swiss Federal Institute of Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Sclerosis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking Description
No randomisation
Allocation
Non-Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy Control
Arm Type
Other
Arm Description
Healthy controls, who signed an informed consent, age ≥18 years old will be age and sex matched to the SSc patients
Arm Title
Systemic sclerosis patients
Arm Type
Other
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Measurment with Aspirational Medical Device
Intervention Description
The mechanical properties of healthy and SSc-diseased skin will be assessed by suction based measurements with a new developed Aspirational Medical Device.
Intervention Type
Device
Intervention Name(s)
Measurment with Cutometer MPA 580
Intervention Description
The mechanical properties of healthy and SSc-diseased skin will be assessed by CE-marked Cutometer MPA 580
Primary Outcome Measure Information:
Title
Mechanical characterization of healthy and diseased skin using novel aspiration device and comparing it to the already validated Cutometer® MPA 580.
Description
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).
Time Frame
one visit, one measurement, one year
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
-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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Distler, Prof.Dr.med
Organizational Affiliation
Department of Rheumatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Rheumatology, University Hospital Zurich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
32493508
Citation
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.
Results Reference
derived
Learn more about this trial
Suction Based Characterization of Healthy and Diseased Skin
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