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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Northwestern University
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Percent agreement of scratching between the experimental sensor and the infrared camera
Study Overview
Brief Summary
Pilot study of flexible and wearable sensor to monitor nocturnal scratching behavior
Detailed Description
Present an advanced flexible, and wearable sensor intimately coupled to the skin that can measure the full spectrum of relevant physiological parameters associated with atopic dermatitis including scratch count, scratch duration, scratch intensity, heart rate, heart rate variability and respiratory rate.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 2 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Crisaborole and wearable sensor
Subjects will apply topical crisaborole twice daily to the affected atopic dermatitis areas for three weeks.
Intervention: Crisaborole (Drug)
Crisaborole and wearable sensor
Subjects will apply topical crisaborole twice daily to the affected atopic dermatitis areas for three weeks.
Intervention: Scratch sensor (Device)
Outcomes
Primary Outcomes
Percent agreement of scratching between the experimental sensor and the infrared camera
Time Frame: 3 weeks
Secondary Outcomes
- Improvement of sleep parameters (time asleep) measured by the experimental sensor during treatment(3 weeks)
- Improvement of sleep parameters (heart rate) measured by the experimental sensor(3 weeks)
- Improvement of sleep parameters (time until onset of sleep) measured by the experimental sensor(3 weeks)
- Improvement of sleep parameters (respiratory rate) measured by the experimental sensor(3 weeks)
Investigators
Shuai (Steve) Xu
Principal Investigator
Northwestern University