RecruitingNCT07645820

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

Evaluation of a Non-Invasive Device for Early Detection of Flares in Adults and Adolescents With Atopic Dermatitis


Sponsor

Castle Biosciences Incorporated

Enrollment

450 participants

Start Date

May 29, 2026

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 12 YearsMax Age: 89 Years

Inclusion Criteria6

  • Participants may be eligible if they:
  • Are 12 to 89 years old.
  • Have been diagnosed with atopic dermatitis (eczema).
  • Have had at least one atopic dermatitis flare within the past 2 months.
  • Are willing and able to use the Nevisense Go device at home, complete an electronic symptom diary, and attend study visits.
  • If currently using systemic treatment for atopic dermatitis, have been on the same treatment for at least 3 months and do not plan to change treatment during the study.

Exclusion Criteria5

  • Participants may not be eligible if they:
  • Are unwilling or unable to avoid applying creams, lotions, ointments, or soap to measurement areas for 6 hours before measurements.
  • Do not have suitable skin areas for study measurements.
  • Have another skin condition that may affect study assessments.
  • Are pregnant.

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Interventions

DEVICENevisense 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.


Locations(4)

U.S. Dermatology Partners

Phoenix, Arizona, United States

Las Vegas Dermatology

Las Vegas, Nevada, United States

StracSkin, PLLC

Portsmouth, New Hampshire, United States

Harrison Institute for Clinical Research

Missouri City, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07645820


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