Wearable Skin Sensors to Assess Nocturnal Scratch Behavior

October 12, 2023 updated by: Shuai (Steve) Xu, Northwestern University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

23

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Participants with mild to moderate atopic dermatitis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent agreement of scratching between the experimental sensor and the infrared camera
Time Frame: 3 weeks
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of sleep parameters (time asleep) measured by the experimental sensor during treatment
Time Frame: 3 weeks
Baseline compared to treatment time points will be compared in units of time (minutes/hours)
3 weeks
Improvement of sleep parameters (time until onset of sleep) measured by the experimental sensor
Time Frame: 3 weeks
Baseline compared to treatment time points will be compared in units of time (minutes/hours)
3 weeks
Improvement of sleep parameters (heart rate) measured by the experimental sensor
Time Frame: 3 weeks
Baseline compared to treatment time points will be compared in units of beats/min
3 weeks
Improvement of sleep parameters (respiratory rate) measured by the experimental sensor
Time Frame: 3 weeks
Baseline compared to treatment time points will be compared in units of breaths/min.
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

Pfizer

Investigators

  • Principal Investigator: Shuai Xu, Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2019

Primary Completion (Actual)

August 30, 2021

Study Completion (Actual)

August 24, 2022

Study Registration Dates

First Submitted

September 6, 2018

First Submitted That Met QC Criteria

December 7, 2018

First Posted (Actual)

December 10, 2018

Study Record Updates

Last Update Posted (Actual)

October 13, 2023

Last Update Submitted That Met QC Criteria

October 12, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 052018SX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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