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Evaluation of a Non-Invasive Device for Early Detection of Atopic Dermatitis Flares (Detect-AD)

10 septembre 2026 mis à jour par: Castle Biosciences Incorporated

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

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

La dermatite atopique

Intervention / Traitement

Dispositif: Nevisense electrical impedance spectroscopy

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

450

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Nom: Clare Johnson E VP Clinical Research
Numéro de téléphone: 602-499-0301
E-mail: cjohnson@castlebiosciences.com

Lieux d'étude

États-Unis
- Arizona
  - Phoenix, Arizona, États-Unis, 85006
    - Recrutement
    - U.S. Dermatology Partners
    - Chercheur principal:
      
      Margaret Kessler, MD
- Maryland
  - Rockville, Maryland, États-Unis, 20850
    - Recrutement
    - U.S. Dermatology Partners Rockville
    - Chercheur principal:
      
      Benjamin Lockshin, MD, FAAD
- Michigan
  - Caledonia, Michigan, États-Unis, 49316
    - Recrutement
    - Derm Research Institute, PLC
    - Chercheur principal:
      
      Kristi Hawley, DO
- Missouri
  - Lee's Summit, Missouri, États-Unis, 64064
    - Recrutement
    - U.S. Dermatology Partners Lee's Summit
    - Chercheur principal:
      
      Mark Fleischman, MD, FAAD
- Nevada
  - Henderson, Nevada, États-Unis, 89052
    - Recrutement
    - Advanced Dermatology and Cosmetic Surgery - Henderson
    - Chercheur principal:
      
      Grace (Kim) Dowty, DO, FAOCD, FAAD
  - Las Vegas, Nevada, États-Unis, 89144
    - Recrutement
    - Las Vegas Dermatology
    - Chercheur principal:
      
      David Cotter, MD, PhD
- New Hampshire
  - Portsmouth, New Hampshire, États-Unis, 03801
    - Recrutement
    - StracSkin, PLLC
    - Chercheur principal:
      
      Abel Jarell, MD, FAAD
- Texas
  - Missouri City, Texas, États-Unis, 77459
    - Recrutement
    - Harrison Dermatology
    - Chercheur principal:
      
      Harrison Nguyen, MD, MBA, MPH, DTM&H FAAD
- Virginia
  - Norfolk, Virginia, États-Unis, 23502
    - Recrutement
    - Virginia Clinical Research, Inc
    - Chercheur principal:
      
      Robert Pariser, MD
- West Virginia
  - Morgantown, West Virginia, États-Unis, 26505
    - Recrutement
    - West Virginia Research Institute
    - Chercheur principal:
      
      Rola Gharib, MD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

Enfant
Adulte
Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Relationship between skin measurements and subsequent atopic dermatitis flares Délai: 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.	Measurements taken over 90 days, 5 days a week
Develop and validate an algorithm using Nevisense Go EIS Délai: 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	From enrollment until end of treatment at 90 days.

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
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. Délai: From enrollment until end of study at 90 days		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 Délai: 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).	From time of enrollment until end of study at 90 days.
To assess the relationship between EIS measurements of skin and resolution of AD flares. Délai: From enrollment until end of study at 90 days		From enrollment until end of study at 90 days
To assess the feasibility of using the Nevisense Go device. Délai: Enrollment to Day 90 (end of study)		Enrollment to Day 90 (end of study)
To assess adherence to using the Nevisense Go device. Délai: Enrollment to Day 90 (end of study)		Enrollment to Day 90 (end of study)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Castle Biosciences Incorporated

Collaborateurs

SciBase AB

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

4 juin 2026

Achèvement primaire (Estimé)

1 avril 2027

Achèvement de l'étude (Estimé)

31 décembre 2027

Dates d'inscription aux études

Première soumission

9 juin 2026

Première soumission répondant aux critères de contrôle qualité