Clinical trial NCT03581747: Detection of Skin Epithelial Barrier in Patients With Allergic Skin Disorders
Official title: Assessment of Skin Epithelial Barrier Defects in Patients With Allergic Skin Disorders by Electrical Impedance Spectroscopy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atopic Dermatitis
Skin Inflammation
Keywords: Atopic dermatis
Epithelial barrier
Electrical impedance spectroscopy
Allergy
Lead sponsor: Swiss Institute of Allergy and Asthma Research
Sponsor class: OTHER
Collaborators: name: CK-CARE (Christine Kühne - Center for Allergy Research and Education)
name: SciBase AB
First posted: 2018-07-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: The inclusion criteria for patients in this study are as follows:

1. Age 0 - 85 years
2. Diagnosis of atopic dermatitis and/or another disease of the atopic group
3. The inclusion of patients in this study is independent from the current therapy. During the study all patients will be kept on a therapy that is medically indicated

The inclusion criteria for healthy controls in this study are as follows:

1. Age 0 - 85 years
2. No diagnosis or history of allergic disease
3. The inclusion of patients in this study is independent from the current therapy. During the study all patients will be kept on a therapy that is medically indicated Written consent will be obtained after detailed information of the study was given to the participant.

Exclusion criteria:

Unable to give consent or refusal to participate in the study

Primary outcomes:
measure: Comparison of electrical impedance values between lesional and non-lesional skin in patients with atopic dermatitis
timeFrame: At Day 0 on hospital admission
measure: Comparison of electrical impedance values in healthy controls and patients with atopic dermatitis
timeFrame: At Day 0 on hospital admission
Secondary outcomes:
measure: Correlation between electrical impedance measurements and innate and adaptive immune responses
timeFrame: At Day 0 on hospital admission; at Day 10; at Day 20 on completion of treatment.
measure: Correlation between electrical impedance measurements and genes associated with epidermal barrier defects
timeFrame: At Day 0 on hospital admission; at Day 10; at Day 20 on completion of treatment.
measure: Correlation between electrical impedance measurements and immune biomarkers in serum
timeFrame: At Day 0 on hospital admission; at Day 10; at Day 20 on completion of treatment.
measure: Correlation between electrical impedance measurements and the expression profile of relevant proteins at skin tissue level
timeFrame: At Day 0 on hospital admission; at Day 10; at Day 20 on completion of treatment.
Other outcomes:
Locations:
city: Davos Platz
country: Switzerland
facility: Swiss Institute of Allergy and Asthma Research (SIAF)
state: Grisons
Study officials:
References: