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临床试验/NCT03581747
NCT03581747Unknown不适用

Assessment of Skin Epithelial Barrier Defects in Patients With Allergic Skin Disorders by Electrical Impedance Spectroscopy

Swiss Institute of Allergy and Asthma Research1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2018年8月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,000
试验地点
1
主要终点
Comparison of electrical impedance values in healthy controls and patients with atopic dermatitis

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

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

时间窗: 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.

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

时间窗: 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.

次要结局

  • 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 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.)
  • 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 genes associated with epidermal barrier defects(At Day 0 on hospital admission; at Day 10; at Day 20 on completion of treatment.)

研究者

发起方
Swiss Institute of Allergy and Asthma Research
申办方类型
Other
责任方
Sponsor

研究点 (1)

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