Suction Based Characterization of Healthy and Diseased Skin

Systemic Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03644225
• Other study ID #: Swissmedic:2017-MD_0045
• Secondary ID: 2017-01154
• Status: Completed
• Phase: N/A
• Start date: June 11, 2018
• Est. completion date: June 4, 2019

Study information

• Verified date: May 2023
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Mesurments will be done with the new developed Aspiration Device_Nimble and with the CE-certified Cutometer MPA 580.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: June 4, 2019
• Est. primary completion date: June 4, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Systemic Sclerosis

Intervention

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.
• Measurment with Cutometer MPA 580
The mechanical properties of healthy and SSc-diseased skin will be assessed by CE-marked Cutometer MPA 580

Locations

Country	Name	City	State
Switzerland	Department of Rheumatology, University Hospital Zurich	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
Oliver Distler	Swiss Federal Institute of Technology

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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