Suction Based Characterization of Healthy and Diseased Skin

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.

Study Overview

• Status: Completed
• Conditions: Systemic Sclerosis
• Intervention / Treatment: Device: Measurment with Aspirational Medical Device; Device: Measurment with 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 Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zürich, Switzerland, 8091
    • Department of Rheumatology, University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Healthy Control; 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; 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
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	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Oliver Distler
• Collaborators: Swiss Federal Institute of Technology
• Investigators: Principal Investigator: Oliver Distler, Prof.Dr.med, Department of rheumatology

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2018
• Primary Completion (Actual): June 4, 2019
• Study Completion (Actual): June 4, 2019

Study Registration Dates

• First Submitted: May 4, 2018
• First Submitted That Met QC Criteria: August 21, 2018
• First Posted (Actual): August 23, 2018

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Connective Tissue Diseases; Scleroderma, Systemic; Scleroderma, Diffuse
• Other Study ID Numbers: Swissmedic:2017-MD_0045; 2017-01154 (Other Identifier: Ethikkommission)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No