Wearable Skin Sensors to Assess Nocturnal Scratch Behavior

Study Overview
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Brief Summary
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Pilot study of flexible and wearable sensor to monitor nocturnal scratching behavior

Detailed Description
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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.

Official Title
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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

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: Crisaborole
* Device: Scratch sensor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Crisaborole and wearable sensor<br>Subjects will apply topical crisaborole twice daily to the affected atopic dermatitis areas for three weeks. | Drug: Crisaborole<br>* Subject to apply topical crisaborole twice daily to the affected atopic dermatitis areas<br>Device: Scratch sensor<br>* advanced, flexible and wearable skin sensor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent agreement of scratching between the experimental sensor and the infrared camera |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of sleep parameters (time asleep) measured by the experimental sensor during treatment | Baseline compared to treatment time points will be compared in units of time (minutes/hours) | 3 weeks | 
| Improvement of sleep parameters (time until onset of sleep) measured by the experimental sensor | Baseline compared to treatment time points will be compared in units of time (minutes/hours) | 3 weeks | 
| Improvement of sleep parameters (heart rate) measured by the experimental sensor | Baseline compared to treatment time points will be compared in units of beats/min | 3 weeks | 
| Improvement of sleep parameters (respiratory rate) measured by the experimental sensor | Baseline compared to treatment time points will be compared in units of breaths/min. | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wearables, Atopic Dermatitis, Scratch sensor