Atopic Dermatitis
Conditions
Keywords
Electrical Impedance Spectroscopy, EIS, Atopic Dermatitis, Eczema, Flare, Skin barrier function, Flare Prediction, Dermatology, Nevisense Go, Skin Barrier Dysfunction
Brief 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.
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.
Interventions
The NevisenseGo device will collect skin measurements from people with atopic dermatitis (AD) to see if it can effectively predict a flare in disease.
Sponsors
Castle Biosciences Incorporated
SciBase AB
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to 89 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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 | From time of enrollment until end of study at 90 days. | Including Eczema Area and Severity Index (EASI), Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD), and body surface area (BSA). |
| To assess the relationship between EIS measurements of skin and resolution of AD flares. | From enrollment until end of study at 90 days | — |
| To assess the feasibility of using the Nevisense Go device. | Enrollment to Day 90 (end of study) | — |
| To assess adherence to using the Nevisense Go device. | Enrollment to Day 90 (end of study) | — |
Countries
United States
Contacts
CONTACTClare Johnson E VP Clinical Research
Outcome results
None listed