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Trial record 3 of 12 for:    electrical impedance spectroscopy

Detection of Skin Epithelial Barrier in Patients With Allergic Skin Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03581747
Recruitment Status : Unknown
Verified July 2018 by Swiss Institute of Allergy and Asthma Research.
Recruitment status was:  Recruiting
First Posted : July 10, 2018
Last Update Posted : September 10, 2018
Sponsor:
Collaborators:
CK-CARE (Christine Kühne – Center for Allergy Research and Education)
SciBase AB
Information provided by (Responsible Party):
Swiss Institute of Allergy and Asthma Research

Tracking Information
First Submitted Date April 25, 2018
First Posted Date July 10, 2018
Last Update Posted Date September 10, 2018
Actual Study Start Date August 1, 2018
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 9, 2018)
  • Comparison of electrical impedance values between lesional and non-lesional skin in patients with atopic dermatitis [ Time Frame: At Day 0 on hospital admission ]
    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.
  • Comparison of electrical impedance values in healthy controls and patients with atopic dermatitis [ Time Frame: At Day 0 on hospital admission ]
    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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 9, 2018)
  • Correlation between electrical impedance measurements and innate and adaptive immune responses [ Time Frame: At Day 0 on hospital admission; at Day 10; at Day 20 on completion of treatment. ]
    50 ml of peripheral venous blood will be taken in lithium heparin 7 ml tubes and one 7 ml tube without anticoagulant for serum collection. Peripheral blood mononuclear cells (PBMC) will be purified by ficoll density gradient from venous blood and then analysed by multicolor flow cytometry, to characterize T cells, B cells, Natural Killer cells and other immune cell populations. Possible correlations between EI values and these cell subsets will be described.
  • Correlation between electrical impedance measurements and genes associated with epidermal barrier defects [ Time Frame: At Day 0 on hospital admission; at Day 10; at Day 20 on completion of treatment. ]
    From venous blood, DNA will be isolated to detect specific skin barrier mutations, such as filaggrin defects. Possible correlations between EI values and these defects will be identified.
  • Correlation between electrical impedance measurements and immune biomarkers in serum [ Time Frame: At Day 0 on hospital admission; at Day 10; at Day 20 on completion of treatment. ]
    From serum, cytokines and immunoglobulins will be measured, by using protein analysis methods (immunoblotting, ELISA), in order to identify a possible correlation between EI values and specific serum biomarkers.
  • Correlation between electrical impedance measurements and the expression profile of relevant proteins at skin tissue level [ Time Frame: At Day 0 on hospital admission; at Day 10; at Day 20 on completion of treatment. ]
    Skin biopsies will be collected, Real Time Polymerase Chain Reaction (PCR) and immunohistochemistry will be performed to analyse relevant skin molecules, such epidermal barrier proteins and tight junction proteins. Possible correlations between EI values and the expression of these proteins will be described.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Atopic Dermatitis
  • Skin Inflammation
Intervention Device: Nevisense
Measurement of electrical impedance
Study Groups/Cohorts
  • Subjects with atopic dermatitis
    Intervention: Device: Nevisense
  • Controls
    Intervention: Device: Nevisense
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: July 9, 2018)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
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

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT03581747
Other Study ID Numbers EB/EIS
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Swiss Institute of Allergy and Asthma Research
Study Sponsor Swiss Institute of Allergy and Asthma Research
Collaborators
  • CK-CARE (Christine Kühne – Center for Allergy Research and Education)
  • SciBase AB
Investigators Not Provided
PRS Account Swiss Institute of Allergy and Asthma Research
Verification Date July 2018