<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03770858</url>
  </required_header>
  <id_info>
    <org_study_id>052018SX</org_study_id>
    <nct_id>NCT03770858</nct_id>
  </id_info>
  <brief_title>Wearable Skin Sensors to Assess Nocturnal Scratch Behavior</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Northwestern University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pilot study of flexible and wearable sensor to monitor nocturnal scratching behavior&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Present an advanced flexible, and wearable sensor intimately coupled to the skin that can&#xD;
      measure the full spectrum of relevant physiological parameters associated with atopic&#xD;
      dermatitis including scratch count, scratch duration, scratch intensity, heart rate, heart&#xD;
      rate variability and respiratory rate.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 18, 2019</start_date>
  <completion_date type="Anticipated">March 31, 2023</completion_date>
  <primary_completion_date type="Actual">October 30, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percent agreement of scratching between the experimental sensor and the infrared camera</measure>
    <time_frame>3 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement of sleep parameters (time asleep) measured by the experimental sensor during treatment</measure>
    <time_frame>3 weeks</time_frame>
    <description>Baseline compared to treatment time points will be compared in units of time (minutes/hours)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement of sleep parameters (time until onset of sleep) measured by the experimental sensor</measure>
    <time_frame>3 weeks</time_frame>
    <description>Baseline compared to treatment time points will be compared in units of time (minutes/hours)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement of sleep parameters (heart rate) measured by the experimental sensor</measure>
    <time_frame>3 weeks</time_frame>
    <description>Baseline compared to treatment time points will be compared in units of beats/min</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement of sleep parameters (respiratory rate) measured by the experimental sensor</measure>
    <time_frame>3 weeks</time_frame>
    <description>Baseline compared to treatment time points will be compared in units of breaths/min.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">23</enrollment>
  <condition>Atopic Dermatitis</condition>
  <arm_group>
    <arm_group_label>Crisaborole and wearable sensor</arm_group_label>
    <description>Subjects will apply topical crisaborole twice daily to the affected atopic dermatitis areas for three weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Crisaborole</intervention_name>
    <description>Subject to apply topical crisaborole twice daily to the affected atopic dermatitis areas</description>
    <arm_group_label>Crisaborole and wearable sensor</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Scratch sensor</intervention_name>
    <description>advanced, flexible and wearable skin sensor</description>
    <arm_group_label>Crisaborole and wearable sensor</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants with mild to moderate atopic dermatitis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants with mild to moderate atopic dermatitis ages 2 years or older. This will&#xD;
             be determined by clinical diagnosis of AD according to the Hanifin and Rajka criteria&#xD;
             with a baseline Investigators Global Assessment score of mild (2) or moderate (3)&#xD;
&#xD;
          -  Systemic therapy use (e.g. oral corticosteroid, cyclosporine, methotrexate,&#xD;
             phototherapy) within 28 days of subject enrollment&#xD;
&#xD;
          -  Topical corticosteroid use or topical calcineurin inhibitor use within 14 days of&#xD;
             subject enrollment&#xD;
&#xD;
          -  Willingness and ability to set up an infrared video camera nightly&#xD;
&#xD;
          -  Willing to apply topical crisaborole twice daily to affected atopic dermatitis areas&#xD;
             of the body&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active skin or systemic infection&#xD;
&#xD;
          -  Inability to operate a smartphone or video camera&#xD;
&#xD;
          -  Active atopic dermatitis on he dorsum of the hand or suprasternal notch&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shuai Xu</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>September 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>September 27, 2022</last_update_submitted>
  <last_update_submitted_qc>September 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Shuai (Steve) Xu</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Wearables</keyword>
  <keyword>Atopic Dermatitis</keyword>
  <keyword>Scratch sensor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis, Atopic</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Eczema</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03770858
org study id: 052018SX
nct id: NCT03770858
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Pilot study of flexible and wearable sensor to monitor nocturnal scratching behavior
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.
observational model: Cohort
time perspective: Prospective
measure: Percent agreement of scratching between the experimental sensor and the infrared camera
time frame: 3 weeks
measure: Improvement of sleep parameters (time asleep) measured by the experimental sensor during treatment
time frame: 3 weeks
description: Baseline compared to treatment time points will be compared in units of time (minutes/hours)
measure: Improvement of sleep parameters (time until onset of sleep) measured by the experimental sensor
time frame: 3 weeks
description: Baseline compared to treatment time points will be compared in units of time (minutes/hours)
measure: Improvement of sleep parameters (heart rate) measured by the experimental sensor
time frame: 3 weeks
description: Baseline compared to treatment time points will be compared in units of beats/min
measure: Improvement of sleep parameters (respiratory rate) measured by the experimental sensor
time frame: 3 weeks
description: Baseline compared to treatment time points will be compared in units of breaths/min.
arm group label: Crisaborole and wearable sensor
description: Subjects will apply topical crisaborole twice daily to the affected atopic dermatitis areas for three weeks.
intervention type: Drug
intervention name: Crisaborole
description: Subject to apply topical crisaborole twice daily to the affected atopic dermatitis areas
arm group label: Crisaborole and wearable sensor
intervention type: Device
intervention name: Scratch sensor
description: advanced, flexible and wearable skin sensor
arm group label: Crisaborole and wearable sensor
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Shuai Xu
role: Principal Investigator
affiliation: Northwestern University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Shuai (Steve) Xu
investigator title: Principal Investigator
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
sharing ipd: No