Suction Based Characterization of Healthy and Diseased Skin

Not Applicable

Completed

• Conditions: Systemic Sclerosis
• Interventions: Device: Measurment with Aspirational Medical Device; Device: Measurment with Cutometer MPA 580

• Registration Number: NCT03644225
• Lead Sponsor: Oliver Distler

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

Study Timeline

• Study First Submitted: 2018-05-04
• Study Start: 2018-06-11
• Study First Submitted QC: 2018-08-21
• Study First Posted: 2018-08-23
• Primary Completion: 2019-06-04
• Study Completion: 2019-06-04
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Systemic sclerosis patients	Measurment with Cutometer MPA 580	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
Healthy Control	Measurment with Aspirational Medical Device	Healthy controls, who signed an informed consent, age ≥18 years old will be age and sex matched to the SSc patients
Healthy Control	Measurment with Cutometer MPA 580	Healthy controls, who signed an informed consent, age ≥18 years old will be age and sex matched to the SSc patients
Systemic sclerosis patients	Measurment with Aspirational Medical Device	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

Primary Outcome Measures

Name	Time	Method
Mechanical characterization of healthy and diseased skin using novel aspiration device and comparing it to the already validated Cutometer® MPA 580.	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).

Trial Locations

Locations (1)

Department of Rheumatology, University Hospital Zurich; 🇨🇭 Zürich, Switzerland