Wearable Skin Sensors to Assess Nocturnal Scratch Behavior
A Single Arm, Prospective Clinical Study Using Novel Wearable Sensors to Assess the Improvement of Nocturnal Scratch Behavior and Sleep Quality in Children With Mild-to-moderate Atopic Dermatitis Treated With Topical Crisaborole
1 other identifier
observational
23
1 country
1
Brief Summary
Pilot study of flexible and wearable sensor to monitor nocturnal scratching behavior
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2018
CompletedFirst Posted
Study publicly available on registry
December 10, 2018
CompletedStudy Start
First participant enrolled
April 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 24, 2022
CompletedOctober 13, 2023
October 1, 2023
2.4 years
September 6, 2018
October 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent agreement of scratching between the experimental sensor and the infrared camera
3 weeks
Secondary Outcomes (4)
Improvement of sleep parameters (time asleep) measured by the experimental sensor during treatment
3 weeks
Improvement of sleep parameters (time until onset of sleep) measured by the experimental sensor
3 weeks
Improvement of sleep parameters (heart rate) measured by the experimental sensor
3 weeks
Improvement of sleep parameters (respiratory rate) measured by the experimental sensor
3 weeks
Study Arms (1)
Crisaborole and wearable sensor
Subjects will apply topical crisaborole twice daily to the affected atopic dermatitis areas for three weeks.
Interventions
Subject to apply topical crisaborole twice daily to the affected atopic dermatitis areas
Eligibility Criteria
Participants with mild to moderate atopic dermatitis
You may qualify if:
- Participants with mild to moderate atopic dermatitis ages 2 years or older. This will be determined by clinical diagnosis of AD according to the Hanifin and Rajka criteria with a baseline Investigators Global Assessment score of mild (2) or moderate (3)
- Systemic therapy use (e.g. oral corticosteroid, cyclosporine, methotrexate, phototherapy) within 28 days of subject enrollment
- Topical corticosteroid use or topical calcineurin inhibitor use within 14 days of subject enrollment
- Willingness and ability to set up an infrared video camera nightly
- Willing to apply topical crisaborole twice daily to affected atopic dermatitis areas of the body
You may not qualify if:
- Active skin or systemic infection
- Inability to operate a smartphone or video camera
- Active atopic dermatitis on he dorsum of the hand or suprasternal notch
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwestern Universitylead
- Pfizercollaborator
Study Sites (1)
Northwestern University
Chicago, Illinois, 60611, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shuai Xu
Northwestern University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 6, 2018
First Posted
December 10, 2018
Study Start
April 18, 2019
Primary Completion
August 30, 2021
Study Completion
August 24, 2022
Last Updated
October 13, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share