Skip to main content
OpenTrials
Completed

NCT Number: NCT03644225

Suction Based Characterization of Healthy and Diseased Skin

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Rheumatology, University Hospital Zurich

Zurich, 8091, Switzerland

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Measurment with Cutometer MPA 580

Device

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

Primary outcomes

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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Oliver Distler

Other

Collaborators

  • Swiss Federal Institute of Technology

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 23, 2018
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.