Atopic Dermatitis
Conditions
Keywords
Wearables, Atopic Dermatitis, Scratch sensor
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.
Interventions
DRUGCrisaborole
Subject to apply topical crisaborole twice daily to the affected atopic dermatitis areas
DEVICEScratch sensor
advanced, flexible and wearable skin sensor
Sponsors
Pfizer
Northwestern University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent agreement of scratching between the experimental sensor and the infrared camera | 3 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of sleep parameters (time asleep) measured by the experimental sensor during treatment | 3 weeks | Baseline compared to treatment time points will be compared in units of time (minutes/hours) |
| Improvement of sleep parameters (time until onset of sleep) measured by the experimental sensor | 3 weeks | Baseline compared to treatment time points will be compared in units of time (minutes/hours) |
| Improvement of sleep parameters (heart rate) measured by the experimental sensor | 3 weeks | Baseline compared to treatment time points will be compared in units of beats/min |
| Improvement of sleep parameters (respiratory rate) measured by the experimental sensor | 3 weeks | Baseline compared to treatment time points will be compared in units of breaths/min. |
Countries
United States
Outcome results
None listed