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Suction Based Characterization of Healthy and Diseased Skin

Primary Purpose

Systemic Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Measurment with Aspirational Medical Device
Measurment with Cutometer MPA 580
Sponsored by
Oliver Distler
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Systemic Sclerosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Rheumatology, University Hospital Zurich

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Healthy Control

Systemic sclerosis patients

Arm Description

Healthy controls, who signed an informed consent, age ≥18 years old will be age and sex matched to the SSc 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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
May 4, 2018
Last Updated
May 8, 2023
Sponsor
Oliver Distler
Collaborators
Swiss Federal Institute of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT03644225
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 11, 2018 (Actual)
Primary Completion Date
June 4, 2019 (Actual)
Study Completion Date
June 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Oliver Distler
Collaborators
Swiss Federal Institute of Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Sclerosis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Masking Description
No randomisation
Allocation
Non-Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy Control
Arm Type
Other
Arm Description
Healthy controls, who signed an informed consent, age ≥18 years old will be age and sex matched to the SSc patients
Arm Title
Systemic sclerosis patients
Arm Type
Other
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Measurment with Aspirational Medical Device
Intervention Description
The mechanical properties of healthy and SSc-diseased skin will be assessed by suction based measurements with a new developed Aspirational Medical Device.
Intervention Type
Device
Intervention Name(s)
Measurment with Cutometer MPA 580
Intervention Description
The mechanical properties of healthy and SSc-diseased skin will be assessed by CE-marked Cutometer MPA 580
Primary Outcome Measure Information:
Title
Mechanical characterization of healthy and diseased skin using novel aspiration device and comparing it to the already validated Cutometer® MPA 580.
Description
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).
Time Frame
one visit, one measurement, one year

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Distler, Prof.Dr.med
Organizational Affiliation
Department of Rheumatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Rheumatology, University Hospital Zurich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
32493508
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.
Results Reference
derived

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Suction Based Characterization of Healthy and Diseased Skin

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