Evaluation of a Non-Invasive Device for Early Detection of Atopic Dermatitis Flares

Condition(s) studied

Investigational drug(s) / intervention(s)

Nevisense electrical impedance spectroscopy: The NevisenseGo device will collect skin measurements from people with atopic dermatitis (AD) to see if it can effectively predict a flare in disease.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Relationship between skin measurements and subsequent atopic dermatitis flares — Measurements taken over 90 days, 5 days a week
  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.
• Develop and validate an algorithm using Nevisense Go EIS — From enrollment until end of treatment at 90 days.
  To develop and validate an algorithm using Nevisense Go EIS data that can calculate the momentary likelihood of AD flares, before signs or symptoms

Trial sites (10)