Skin Barrier Assessment

There is an increasing focus on the importance of the skin barrier in the development, characterization, and management of atopic disorders. Barrier defects have been reported in atopic dermatitis (AD), asthma, chronic rhinosinusitis, allergic rhinitis, esophagitis, and colitis. Assessment of barrier function provides insight into these disorders, but the assessment of the skin barrier has to date been limited to research methods that are not suited for clinical use. Atopic dermatitis (AD), also referred to as eczema, is the most common complex chronic inflammatory skin disease. It is well known that an impaired skin barrier is a critical factor in the development of AD/eczema. Skin barrier dysfunction can lead to the development of AD, and poor skin barrier function at birth is predictive of the development of atopic dermatitis.

It has also been shown that AD or impaired skin barrier often precedes food allergy. Reduced skin barrier function allows environmental food allergens to penetrate the skin, leading to systemic allergen sensitization. This disease progression is called “The atopic march” and refers to the natural progression of atopic diseases from AD in infancy to atopic asthma in school age children.

A new disease model, “The epithelial barrier hypothesis” has been presented in an article in the journal Nature Reviews (Akdis et al, “Does the epithelial barrier hypothesis explain the increase in allergy, autoimmunity and other chronic conditions?” Nature Reviews 2021). The research is grounded in the fact that there has been a steep increase in allergic and autoimmune diseases, affecting more than one billion people worldwide. Intact skin and mucosal barriers are crucial for the maintenance of tissue homeostasis as they protect host tissues from infections, environmental toxins, pollutants, and allergens. A defective epithelial barrier has been demonstrated in allergic and autoimmune conditions such as asthma, atopic dermatitis, allergic rhinitis, and many more diseases. The epithelial barrier hypothesis proposes that the increase in epithelial barrier-damaging agents linked to industrialization, urbanization, and modern life is associated with the rise in allergies, autoimmune, and other chronic conditions. The hypothesis is also presented in a video, please follow this link: https://youtu.be/7j3l_EpIS6Q

Skin Barrier Assessments with EIS

Previous work

SciBase’s Nevisense device uses Electrical Impedance Spectroscopy (EIS). The system is FDA-approved for use in cancer detection and now is being brought to a new clinical area, barrier-related disorders. Building on work done within AD by SciBase’s founder, Professor Stig Ollmar, over a decade ago, our current research aims to establish a method to assess the skin barrier function in vivo. This novel method can be used as a diagnostic tool for barrier-related inflammatory disorders of the skin, such as AD (please see section 2 in Publications).

Recent studies

A date study entitled ‘Direct assessment of skin epithelial barrier by electrical impedance spectroscopy’ (See: https://onlinelibrary.wiley.com/doi/10.1111/all.13824), was published in the journal Allergy, European Journal of Allergy and Clinical Immunology, and demonstrates that ‘Electrical Impedance spectroscopy is a rapid and reliable diagnostic tool to detect skin barrier defects.’ The study illustrates the potential for the use of Nevisense in the routine clinical evaluation of the skin barrier and the investigation of barrier-related disorders.

Another study presented in Allergy, titled “Electrical impedance spectroscopy for the characterization of skin barrier in atopic dermatitis” (See: https://onlinelibrary.wiley.com/doi/10.1111/all.14842) shows that Nevisense is a useful tool to detect skin barrier dysfunction in vivo. EIS is valuable for the assessment of AD severity, progression, and therapy efficacy in a clinical setting.

Future vision

The future vision for Nevisense in the barrier indication is to be used as a device that investigates the skin barrier quickly and easily in a routine clinical setting (e.g. to assess treatment responses or to identify skin barrier defective patients). Early detection of skin barrier-defective babies before AD symptoms present is an unmet need. Early AD identification would allow babies to be included in skin barrier protection programs to prevent the development of AD. AD affects more than 10% of the world’s population and 80% of these patients are babies. The breadth of the potential applications is extraordinary – disorders such as eczema, food allergies, and asthma, and even some gastrointestinal disorders involve the barrier.

Hear SciBase CEOs thoughts on the impact of EIS and AI on skin barrier diagnostics

For more information, please see: https://scibase.com/new-study-opens-up-new-applications-for-scibases-product-nevisense/

Products/Solutions

The Nevisense product family, consisting of the device Nevisense and the smaller pen-size device Nevisense Go, bothperform electrical impedance measurements that reflects objective information on cellular structure, cellular orientation, size and other properties of the skin which are not available to any visual method for assessing skin barrier characteristics.

 

Nevisense Go

Nevisense Go is the latest and most advanced tool for measuring the electrical impedance of the skin.

Nevisense Go is a handheld and fully portable device the size of a large pen. It combines the company’s core EIS measurement technology with a new AI-based analysis platform embedded in the device. Each measurement gathers 220 datapoints, from 1 kHz to 1MHz at 10 permutations and 4 depth settings, providing comprehensive analysis of the area being measured.

The result is a flexible tool that will allow easy collection of data and development of new applications.

The first Nevisense Go version is available for skin barrier assessment in research and clinical study applications and does not include a clinical indication (i.e. a non-medical device).

Nevisense Go provides a score after each measurement from an inbuilt AI classifier. It is also possible to download all measurement datapoints for further analysis and development, making Nevisense Go a powerful tool for skin barrier research.

Details:

Nevisense Go	Handheld impedance meter with built in AI analysis
Size	190mm (h), 40mm (w), 25 mm (d), 1,3” (display)
Weight	120 grams
Product safety	IEC 60601-1-2 Electromagnetic compatibility, IEC 62133-2
Connectivity	Wi-Fi & Bluetooth capabilities
Battery	Internal Lithium Polymer 3.7Wh.
Measurement frequencies	11 frequencies logarithmically distributed between 1kHz and 1MHz
Measurement levels	Max measurement current = 10 µA Max measurement voltage = 150 mV

 

Nevisense

Nevisense is a medical device with regulatory approval for detection of skin cancer, but can also be used for barrier research.

The Nevisense system consists of a control unit (1), a probe (2) and disposable electrodes (3). The control unit is used for user interaction through a touch screen and for signal processing of the impedance measurement signals, displaying the electrical impedance measurements on the screen.

Each measurement gathers 700 datapoints, from 1 kHz to 2,5 MHz at 10 permutations and 4 depth settings, providing comprehensive analysis of the area being measured.

It is possible to download all measurement datapoints for further analysis and development, making Nevisense a powerful tool for skin barrier research.

Nevisense
Control unit screen	The control unit has a 12” 800×600 color display with touch screen.
Measurement principle and frequencies	Bioimpedance of the skin is measured micro invasively. Nevisense registers phase and magnitude in four different depths and ten permutations at 35 different frequencies from 1.0 kHz to 2.5 MHz.
Battery	Battery status is indicated on the screen.
Control unit size	150 mm (h) x 400 mm (w) x 300 mm (d)
System weight	Control unit 4 kg, probe unit 100g, battery 420g.
Product safety	The CE-marked products fulfils the quality and safety regulations according to MDR for the clinical indication of skin cancer.
External interfaces	The system is equipped with two USB ports.
Network Connectivity	Nevisense supports connection to local area networks over Ethernet and WiFi.

 

 

Microinvasive electrode

SciBase´s proprietary disposable electrodes enable the electrical signals to reach the depths necessary to gather complete information about the properties of the skin.

The electrode has 5 gold plated bars with 45 microinvasive pins on each bar. The pins function is to penetrate into stratum corneum to warrant adequate electrical contact between the electrode and the underlying skin.

Each of the 5 bars of the electrode can send and receive electrical signals enabling complete coverage of the measurement area at 4 depths and 10 possible permutations over the frequency range of a measurement.

 

Nevisense Dashboard

The dashboard is a web-based visualization and analysis tool. Measurements can be exported from Nevisense or Nevisense Go and imported into the Dashboard.

In the dashboard, it is possible to

• View and compare measurements,
• Review all measurement data points (magnitude and phase shift over the measured frequencies)
• Review calculated parameters, with features associated with bariier function, as well as any AI based analysis.
• perform aggregate comparisons (scatter or boxplots) between selected parameters.
• Export and import the data to/from Excel (where additional datatypes can be added and re-analyzed in the Dashboard