Evaluation of a Non-Invasive Device for Early Detection of Atopic Dermatitis Flares
Recruiting · NCT07645820 · Observational (researchers observe without assigning treatment) · Lead sponsor: Castle Biosciences Incorporated
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
10 locations listed across 9 US states.
- U.S. Dermatology Partners - Phoenix, Arizona, United States
- U.S. Dermatology Partners Rockville - Rockville, Maryland, United States
- Derm Research Institute, PLC - Caledonia, Michigan, United States
- U.S. Dermatology Partners Lee's Summit - Lee's Summit, Missouri, United States
- Advanced Dermatology and Cosmetic Surgery - Henderson - Henderson, Nevada, United States
- Las Vegas Dermatology - Las Vegas, Nevada, United States
- StracSkin, PLLC - Portsmouth, New Hampshire, United States
- Harrison Dermatology - Missouri City, Texas, United States
- Virginia Clinical Research, Inc - Norfolk, Virginia, United States
- West Virginia Research Institute - Morgantown, West Virginia, United States