Wearable Skin Sensors to Assess Nocturnal Scratch Behavior

NCT03770858

Last updated date
Study Location
Northwestern University
Chicago, Illinois, 60611, United States
Contact
312-503-5944

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Atopic Dermatitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
2 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title Wearable Skin Sensors to Assess Nocturnal Scratch Behavior
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
Brief Summary Pilot study of flexible and wearable sensor to monitor nocturnal scratching behavior
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants with mild to moderate atopic dermatitis
Condition Atopic Dermatitis
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
Study Groups/Cohorts Crisaborole and wearable sensor
Subjects will apply topical crisaborole twice daily to the affected atopic dermatitis areas for three weeks.
Interventions:
  • Drug: Crisaborole
  • Device: Scratch sensor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 7, 2018)
15
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study:All
Ages 2 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Dermatology CTU312-503-5944[email protected]
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03770858
Other Study ID Numbers 052018SX
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD:No
Responsible Party Shuai (Steve) Xu, Northwestern University
Study Sponsor Northwestern University
Collaborators Pfizer
Investigators
Principal Investigator:Shuai XuNorthwestern University
PRS Account Northwestern University
Verification Date May 2020