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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 12 Years and 89 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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 Criteria

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.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Recruiting Locations

U.S. Dermatology Partners
Phoenix, Arizona 85006

Las Vegas Dermatology
Las Vegas, Nevada 89144

StracSkin, PLLC
Portsmouth, New Hampshire 03801

Harrison Institute for Clinical Research
Missouri City, Texas 77459
Contact:
Harrison Nguyen, MD, MBA, MPH, DTM&H FAAD

More Details

Status
Recruiting
Sponsor
Castle Biosciences Incorporated

Study Contact

Clare Johnson E VP Clinical Research
602-499-0301
cjohnson@castlebiosciences.com

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.