Suction Based Characterization of Healthy and Diseased Skin

Study Overview
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Brief Summary
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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
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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

Official Title
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Mechanical Characterization of Healthy and Diseased Skin With Suction Based Assessment of Skin Deformability

Conditions
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Systemic Sclerosis

Intervention / Treatment
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* Device: Measurment with Aspirational Medical Device
* Device: Measurment with Cutometer MPA 580


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy Control<br>Healthy controls, who signed an informed consent, age ≥18 years old will be age and sex matched to the SSc patients | Device: Measurment with Aspirational Medical Device<br>* The mechanical properties of healthy and SSc-diseased skin will be assessed by suction based measurements with a new developed Aspirational Medical Device.<br>Device: Measurment with Cutometer MPA 580<br>* The mechanical properties of healthy and SSc-diseased skin will be assessed by CE-marked Cutometer MPA 580<br>|
| Other: Systemic sclerosis patients<br>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 | Device: Measurment with Aspirational Medical Device<br>* The mechanical properties of healthy and SSc-diseased skin will be assessed by suction based measurements with a new developed Aspirational Medical Device.<br>Device: Measurment with Cutometer MPA 580<br>* The mechanical properties of healthy and SSc-diseased skin will be assessed by CE-marked Cutometer MPA 580<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | one visit, one measurement, one year |