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Wearable Skin Sensors to Assess Nocturnal Scratch Behavior

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ClinicalTrials.gov Identifier: NCT03770858
Recruitment Status : Recruiting
First Posted : December 10, 2018
Last Update Posted : May 5, 2020
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Shuai (Steve) Xu, Northwestern University

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

Condition or disease Intervention/treatment
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.

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Study Type : Observational
Estimated 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 : April 1, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Crisaborole

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




Primary Outcome Measures :
  1. Percent agreement of scratching between the experimental sensor and the infrared camera [ Time Frame: 3 weeks ]

Secondary Outcome Measures :
  1. 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)

  2. 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. 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

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants with mild to moderate atopic dermatitis
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03770858


Contacts
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Contact: Dermatology CTU 312-503-5944 NUdermatologyCTU@northwestern.edu

Locations
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United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Dermatology CTU    312-503-5944    DermSensors@northwestern.edu   
Sponsors and Collaborators
Northwestern University
Pfizer
Investigators
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Principal Investigator: Shuai Xu Northwestern University

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Responsible Party: Shuai (Steve) Xu, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT03770858    
Other Study ID Numbers: 052018SX
First Posted: December 10, 2018    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, Northwestern University:
Wearables
Atopic Dermatitis
Scratch sensor
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases