Atopic DermatitisNCT03581747
Detection of Skin Epithelial Barrier in Patients With Allergic Skin Disorders
An observational study of Atopic Dermatitis and Skin Inflammation, run by Swiss Institute of Allergy and Asthma Research at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis, Skin Inflammation
- What is being tested?
- Nevisense
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Aug 2018to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- Unable to give consent or refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Swiss Institute of Allergy and Asthma Research (SIAF)
Davos Platz, Kanton Graubünden, 7270
Arturo O Rinaldi, MSc
Cezmi A Akdis, Prof., M.D.
About this study
Official title: Assessment of Skin Epithelial Barrier Defects in Patients With Allergic Skin Disorders by Electrical Impedance Spectroscopy
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
- Being tested
- Nevisense
- Keywords
- Atopic dermatis, Epithelial barrier, Electrical impedance spectroscopy, Allergy
- Medical subject headings
- Dermatitis, Atopic, Dermatitis, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NevisenseDevice
Measurement of electrical impedance
| Study group | Role | What they receive |
|---|---|---|
| Subjects with atopic dermatitis | Not described Receives: Device: Nevisense | |
| Controls | Not described Receives: Device: Nevisense |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At Day 0 on hospital admission
Secondary outcomes (4)
Correlation between electrical impedance measurements and innate and adaptive immune responses
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: At Day 0 on hospital admission; at Day 10; at Day 20 on completion of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start1 Aug 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swiss Institute of Allergy and Asthma Research
- Sponsor type
- University, hospital or other
- Collaborators
- CK-CARE (Christine Kühne - Center for Allergy Research and Education), SciBase AB
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03581747
- Sponsor's protocol ID
- EB/EIS
- Status last verified
- Jul 2018
- First submitted
- 25 Apr 2018
- Last updated
- 10 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Skin Epithelial Barrier Defects in Patients With Allergic Skin Disorders by Electrical Impedance Spectroscopy
- ClinicalTrials.gov ID
- NCT03581747
- Acronym / sponsor ID
- EB/EIS
- Conditions
- Atopic Dermatitis, Skin Inflammation
- Keywords
- Atopic dermatis, Epithelial barrier, Electrical impedance spectroscopy, Allergy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Swiss Institute of Allergy and Asthma ResearchUniversity, hospital or other
- Collaborators
- CK-CARE (Christine Kühne - Center for Allergy Research and Education), SciBase AB
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 10 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with atopic dermatitis | – | Device: Nevisense |
| Controls | – | Device: Nevisense |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Unable to give consent or refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NevisenseMeasurement of electrical impedance | Device | Controls, Subjects with atopic dermatitis |
Primary outcome
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.
4 secondary outcomes
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis and Skin Inflammation, run by Swiss Institute of Allergy and Asthma Research at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arturo O Rinaldi (+41814100842, arturo.rinaldi@siaf.uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of electrical impedance values between lesional and non-lesional skin in patients with atopic dermatitis (time frame: At Day 0 on hospital admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2018.