Wearable Skin Sensors to Assess Nocturnal Scratch Behavior

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03770858
• Other study ID #: 052018SX
• Status: Completed
• Start date: April 18, 2019
• Est. completion date: August 24, 2022

Study information

• Verified date: October 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: August 24, 2022
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Crisaborole
Subject to apply topical crisaborole twice daily to the affected atopic dermatitis areas

Device:
• Scratch sensor
advanced, flexible and wearable skin sensor

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent agreement of scratching between the experimental sensor and the infrared camera		3 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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