Wearable Skin Sensors to Assess Nocturnal Scratch Behavior

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: Crisaborole; Device: Scratch sensor

• Registration Number: NCT03770858
• Lead Sponsor: Northwestern University

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 Timeline

• Study First Submitted: 2018-09-06
• Study First Submitted QC: 2018-12-07
• Study First Posted: 2018-12-10
• Study Start: 2019-04-18
• Primary Completion: 2021-08-30
• Study Completion: 2022-08-24
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-12
• Last Update Posted: 2023-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Crisaborole and wearable sensor	Scratch sensor	Subjects will apply topical crisaborole twice daily to the affected atopic dermatitis areas for three weeks.
Crisaborole and wearable sensor	Crisaborole	Subjects will apply topical crisaborole twice daily to the affected atopic dermatitis areas for three weeks.

Primary Outcome Measures

Name	Time	Method
Percent agreement of scratching between the experimental sensor and the infrared camera	3 weeks

Secondary Outcome Measures

Name	Time	Method
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 (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 (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 (respiratory rate) measured by the experimental sensor	3 weeks	Baseline compared to treatment time points will be compared in units of breaths/min.

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States