Suction Based Characterization of Healthy and Diseased Skin

Oliver Distler

Status: Completed

Conditions: Systemic Sclerosis

Treatments: Device: Measurment with Cutometer MPA 580; Device: Measurment with Aspirational Medical Device

Study type: Interventional

Funder types: Other

Identifiers

NCT03644225

2017-01154 (Other Identifier)

Swissmedic:2017-MD_0045

Details and patient eligibility

About

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.

Full 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

Enrollment: 67 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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67 participants in 2 patient groups

Healthy Control

Other group

Description:

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

Treatment:

Device: Measurment with Cutometer MPA 580

Device: Measurment with Aspirational Medical Device

Systemic sclerosis patients

Other group

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

Treatment:

Device: Measurment with Cutometer MPA 580

Device: Measurment with Aspirational Medical Device