Suction Based Characterization of Healthy and Diseased Skin

Overview

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.

Full Title of Study: “Mechanical Characterization of Healthy and Diseased Skin With Suction Based Assessment of Skin Deformability”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 4, 2019

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

Interventions

  • Device: Measurment with Aspirational Medical Device
    • The mechanical properties of healthy and SSc-diseased skin will be assessed by suction based measurements with a new developed Aspirational Medical Device.
  • Device: Measurment with Cutometer MPA 580
    • The mechanical properties of healthy and SSc-diseased skin will be assessed by CE-marked Cutometer MPA 580

Arms, Groups and Cohorts

  • Other: Healthy Control
    • Healthy controls, who signed an informed consent, age ≥18 years old will be age and sex matched to the SSc patients
  • Other: Systemic sclerosis 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

Clinical Trial Outcome Measures

Primary Measures

  • 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).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Oliver Distler
  • Collaborator
    • Swiss Federal Institute of Technology
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Oliver Distler, Prof.Dr.med.Oliver Distler, Director of the Department of Rhumatology, University Hospital Zurich – University of Zurich
  • Overall Official(s)
    • Oliver Distler, Prof.Dr.med, Principal Investigator, Department of Rheumatology

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.