Wearable Skin Sensors to Assess Nocturnal Scratch Behavior

Northwestern University

Status: Completed

Conditions: Atopic Dermatitis

Treatments: Device: Scratch sensor; Drug: Crisaborole

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03770858

052018SX

Details and patient eligibility

About

Pilot study of flexible and wearable sensor to monitor nocturnal scratching behavior

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 2+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

23 participants in 1 patient group

Crisaborole and wearable sensor

Description:

Subjects will apply topical crisaborole twice daily to the affected atopic dermatitis areas for three weeks.

Treatment:

Device: Scratch sensor

Drug: Crisaborole