Wearable Skin Sensors to Assess Nocturnal Scratch Behavior

• Sponsor: Northwestern University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03770858
• Collaborator: Pfizer (Industry)
• Enrollment: 15
• Location: 1
• Anticipated Duration (Months): 47
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis	Drug: Crisaborole; Device: Scratch sensor

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 Design

• Study Type: Observational
• Anticipated Enrollment: 15 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Apr 1, 2019
• Anticipated Primary Completion Date: Mar 1, 2023
• Anticipated Study Completion Date: Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Crisaborole and wearable sensor Subjects will apply topical crisaborole twice daily to the affected atopic dermatitis areas for three weeks.	Drug: Crisaborole; Subject to apply topical crisaborole twice daily to the affected atopic dermatitis areas; Device: Scratch sensor; advanced, flexible and wearable skin sensor

Outcome Measures

Primary Outcome Measures

1. Percent agreement of scratching between the experimental sensor and the infrared camera [3 weeks]

Secondary Outcome Measures

1. 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)

2. 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)

3. 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

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University
• Pfizer

Investigators

• Principal Investigator: Shuai Xu, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shuai (Steve) Xu, Principal Investigator, Northwestern University
• ClinicalTrials.gov Identifier: NCT03770858
• Other Study ID Numbers: 052018SX
• First Posted: Dec 10, 2018
• Last Update Posted: Jun 9, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Shuai (Steve) Xu, Principal Investigator, Northwestern University: Wearables; Atopic Dermatitis; Scratch sensor
• Additional relevant MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema

Study Results

No Results Posted as of Jun 9, 2022