Clinical trial NCT03644225: Suction Based Characterization of Healthy and Diseased Skin
Official title: Mechanical Characterization of Healthy and Diseased Skin With Suction Based Assessment of Skin Deformability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Sclerosis
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Swiss Federal Institute of Technology
First posted: 2018-08-23
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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

Eligibility criteria: 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

Primary outcomes:
measure: Mechanical characterization of healthy and diseased skin using novel aspiration device and comparing it to the already validated Cutometer® MPA 580.
timeFrame: one visit, one measurement, one year
Secondary outcomes:
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Department of Rheumatology, University Hospital Zurich
Study officials:
affiliation: Department of Rheumatology
name: Oliver Distler, Prof.Dr.med
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.