NCT03644225

Suction Based Characterization of Healthy and Diseased Skin

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Oliver Distler · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Conditions

• Systemic Sclerosis

Interventions

Type	Name	Description
DEVICE	Measurment with Aspirational Medical Device	The mechanical properties of healthy and SSc-diseased skin will be assessed by suction based measurements with a new developed Aspirational Medical Device.
DEVICE	Measurment with Cutometer MPA 580	The mechanical properties of healthy and SSc-diseased skin will be assessed by CE-marked Cutometer MPA 580

Timeline

• Start date: 2018-06-11
• Primary completion: 2019-06-04
• Completion: 2019-06-04
• First posted: 2018-08-23
• Last updated: 2023-05-09

Locations

1 site across 1 country: Switzerland