Evaluation of a Non-Invasive Device for Early Detection of Atopic Dermatitis Flares
ConditionAtopic Dermatitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-89
SponsorCastle Biosciences Incorporated
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
The study population includes adolescents and adults aged 12 to 89 years with a documented diagnosis of atopic dermatitis and a recent history of disease flares. The multicenter design is intended to support enrollment of a demographically diverse participant population representative of individuals with atopic dermatitis in the United States.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Nevisense electrical impedance spectroscopy
DeviceThe NevisenseGo device will collect skin measurements from people with atopic dermatitis (AD) to see if it can effectively predict a flare in disease.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Relationship 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 week2
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.Secondary outcomes
1
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 days2
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.3
To assess the relationship between EIS measurements of skin and resolution of AD flares.
Time frame
From enrollment until end of study at 90 days4
To assess the feasibility of using the Nevisense Go device.
Time frame
Enrollment to Day 90 (end of study)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Castle Biosciences Incorporated
Lead sponsor
SciBase AB
Collaborator
Source ClinicalTrials.gov