Suction Based Characterization of Healthy and Diseased Skin

NCT03644225 | Completed DMC

• 2 other identifiers: Swissmedic:2017-MD_00452017-01154
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Healthy Control

OTHER

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; Device: Measurment with Cutometer MPA 580

Systemic sclerosis patients

OTHER

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; Device: Measurment with Cutometer MPA 580

Interventions

Measurment with Aspirational Medical Device DEVICE

The mechanical properties of healthy and SSc-diseased skin will be assessed by suction based measurements with a new developed Aspirational Medical Device.

Healthy Control; Systemic sclerosis patients

Measurment with Cutometer MPA 580 DEVICE

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

Healthy Control; Systemic sclerosis patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oliver Distler: lead
• Swiss Federal Institute of Technology: collaborator

Study Sites (1)

Department of Rheumatology, University Hospital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 32493508 DERIVED

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Oliver Distler, Prof.Dr.med

  Department of Rheumatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No randomisation
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.Dr.med.Oliver Distler, Director of the Department of Rhumatology, University Hospital Zurich

Model Details: 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.

Study Record Dates

• First Submitted: May 4, 2018
• First Posted: August 23, 2018
• Study Start: June 11, 2018
• Primary Completion: June 4, 2019
• Study Completion: June 4, 2019
• Last Updated: May 9, 2023

Record last verified: 2023-05

Locations

CH (1)