This study will collect skin measurements from people with atopic dermatitis (AD) using the investigational Nevisense Go device. Participants aged 12 to 89 years with a history of AD flares will use the device at home for about 90 days. Participants will complete device measurements, electronic diary entries, and up to five in-person study visits. The study is based on the idea that changes in skin barrier function may occur before an AD flare becomes visible or symptoms begin. Information collected during the study, including device measurements, diary entries, and investigator assessments, will be used to evaluate whether these changes may help estimate the likelihood of an AD flare before visible signs or symptoms occur.
Atopic dermatitis (AD), also called eczema, is a skin condition associated with repeated periods of worsening symptoms known as flares. Researchers believe that changes in skin barrier function may occur before visible skin changes or symptoms develop. The investigational Nevisense Go device uses Electrical Impedance Spectroscopy (EIS), which measures electrical properties of the skin related to skin barrier function. Previous studies using EIS have shown associations between impedance measurements and skin barrier changes in AD. This study will collect EIS measurements from affected and unaffected skin over time to evaluate whether these measurements may help estimate the likelihood of AD flare onset before visible signs or symptoms occur. The study is observational because device measurements will not be used to guide participant treatment or clinical care during study participation.
Study Type
OBSERVATIONAL
Enrollment
450
The NevisenseGo device will collect skin measurements from people with atopic dermatitis (AD) to see if it can effectively predict a flare in disease.
U.S. Dermatology Partners
Phoenix, Arizona, United States
RECRUITINGLas Vegas Dermatology
Las Vegas, Nevada, United States
RECRUITINGStracSkin, PLLC
Portsmouth, New Hampshire, United States
RECRUITINGHarrison Institute for Clinical Research
Missouri City, Texas, United States
RECRUITINGRelationship between skin measurements and subsequent atopic dermatitis flares
Electrical Impedance Spectroscopy (EIS) measurements collected over time to assess their relationship to subsequent participant-reported atopic dermatitis flares occurring before visible signs or symptoms are apparent.
Time frame: Measurements taken over 90 days, 5 days a week
Develop and validate an algorithm using Nevisense Go EIS
To develop and validate an algorithm using Nevisense Go EIS data that can calculate the momentary likelihood of AD flares, before signs or symptoms
Time frame: From enrollment until end of treatment at 90 days.
To assess the relationship between EIS measurements of skin and AD severity through a variety of patient-reported outcome measures, including itch severity and flare frequency.
Time frame: From enrollment until end of study at 90 days
To assess the relationship between EIS measurements of skin and AD severity through a variety of clinician-reported outcome measures
Including Eczema Area and Severity Index (EASI), Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD), and body surface area (BSA).
Time frame: From time of enrollment until end of study at 90 days.
To assess the relationship between EIS measurements of skin and resolution of AD flares.
Time frame: From enrollment until end of study at 90 days
To assess the feasibility of using the Nevisense Go device.
Time frame: Enrollment to Day 90 (end of study)
To assess adherence to using the Nevisense Go device.
Time frame: Enrollment to Day 90 (end of study)
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