Wearable Skin Sensors to Assess Nocturnal Scratch Behavior

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-18

Study Completion Date

2022-08-24

Brief Summary

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

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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.

Conditions

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Atopic Dermatitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Crisaborole and wearable sensor

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

Crisaborole

Intervention Type DRUG

Subject to apply topical crisaborole twice daily to the affected atopic dermatitis areas

Scratch sensor

Intervention Type DEVICE

advanced, flexible and wearable skin sensor

Interventions

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Crisaborole

Subject to apply topical crisaborole twice daily to the affected atopic dermatitis areas

Intervention Type DRUG

Scratch sensor

advanced, flexible and wearable skin sensor

Intervention Type DEVICE

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

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes