Detection of Skin Epithelial Barrier in Patients With Allergic Skin Disorders

NCT03581747 | Unknown FDA Device

• 1 other identifier: EB/EIS
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The primary function of epithelial tissues is to form a barrier between the body and the external environment, in order to protect the internal tissues from environmental stresses, by minimizing water loss and preventing the entry of pathogens, pollutants and allergens. Allergic disorders, such as atopic dermatitis, have been associated to an impaired epithelial barrier function. Indeed, defects in the epithelial barriers allow tissue-damaging factors to enter the tissue and thus activate the immune response. This study aims to establish a method to assess the epithelial barrier function in vivo by electrical impedance (EI) spectroscopy, a new technique for the characterisation of epithelial tissue. By this technique, a harmless electrical signal is sent through the skin and the response of the tissue is analysed, which is influenced by several cellular properties, such as shape, orientation and size. In order to validate this technique, skin of mice was treated with some molecules able to destroy the epithelial barrier. The investigators observed that, after damaging the barrier, a decrease of the EI can be detected, consistent with the type and degree of the damage. Based on this result, the investigators believe that this technique is a good candidate as an in vivo method to determine skin barrier defects, which might be used in the future as an early diagnostic tool for the prediction of the risk to develop atopic dermatitis in young subjects, allowing the possibility to apply in time possible preventive measures. In addition, this technique might be suitable for the evaluation of a given therapy during the hospitalisation. To confirm this hypothesis, in the present study patients with atopic dermatitis will be recruited. EI measurements will be performed in both lesional and non-lesional skin and values will be compared in order to detect any difference in the electrical response due to the inflammatory state. In addition, in order to evaluate whether these patients have an appreciable defect in their skin electrical behaviour, the investigators will compare non-lesional and lesional skin of patients with skin of healthy volunteers. Peripheral venous blood and skin biopsies will be collected, in oder to characterise several immune cell populations, to detect specific skin barrier mutations and to measure serum cytokines and immunoglobulins. These and some other parameters and will be analysed in order to identify a possible correlation with the EI.

Conditions

Atopic Dermatitis; Skin Inflammation

Keywords

Atopic dermatis; Epithelial barrier; Electrical impedance spectroscopy; Allergy

Outcome Measures

Primary Outcomes (2)

• Comparison of electrical impedance values between lesional and non-lesional skin in patients with atopic dermatitis

  In patients with atopic dermatitis electrical impedance will be measured. Measurements will be performed in both lesional skin and non-lesional skin and values will be compared in order to detect any difference in skin permeability and electrical response due to the inflammatory state.

  At Day 0 on hospital admission

• Comparison of electrical impedance values in healthy controls and patients with atopic dermatitis

  In order to evaluate whether patients have an appreciable defect in their skin electrical behaviour, we will compare the skin of patients with the skin of healthy volunteers.

  At Day 0 on hospital admission

Secondary Outcomes (4)

• Correlation between electrical impedance measurements and innate and adaptive immune responses

  At Day 0 on hospital admission; at Day 10; at Day 20 on completion of treatment.

• Correlation between electrical impedance measurements and genes associated with epidermal barrier defects

  At Day 0 on hospital admission; at Day 10; at Day 20 on completion of treatment.

• Correlation between electrical impedance measurements and immune biomarkers in serum

  At Day 0 on hospital admission; at Day 10; at Day 20 on completion of treatment.

• Correlation between electrical impedance measurements and the expression profile of relevant proteins at skin tissue level

  At Day 0 on hospital admission; at Day 10; at Day 20 on completion of treatment.

Study Arms (2)

Subjects with atopic dermatitis

Device: Nevisense

Controls

Device: Nevisense

Interventions

Nevisense DEVICE

Measurement of electrical impedance

Controls; Subjects with atopic dermatitis

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients will be recruited from the Hochgebirgsklinik in Davos Wolfgang. Healthy controls will be recruited within the heathy population. All individuals will be sampled for skin, blood and other samples after informal consent.

You may qualify if:

• Age 0 - 85 years
• Diagnosis of atopic dermatitis and/or another disease of the atopic group
• Age 0 - 85 years
• No diagnosis or history of allergic disease

You may not qualify if:

• Unable to give consent or refusal to participate in the study

Sponsors & Collaborators

• Swiss Institute of Allergy and Asthma Research: lead
• CK-CARE (Christine Kühne - Center for Allergy Research and Education): collaborator
• SciBase AB: collaborator

Study Sites (1)

Swiss Institute of Allergy and Asthma Research (SIAF)

Davos Platz, Kanton Graubünden, 7270, Switzerland

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic; Dermatitis; Hypersensitivity

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Immune System Diseases

Central Study Contacts

Arturo O Rinaldi

CONTACT

+41814100842; arturo.rinaldi@siaf.uzh.ch

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2018
• First Posted: July 10, 2018
• Study Start: August 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: September 10, 2018

Record last verified: 2018-07

Locations

CH (1)