<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/NCT03813472</url>
  </required_header>
  <id_info>
    <org_study_id>SX08152018</org_study_id>
    <nct_id>NCT03813472</nct_id>
  </id_info>
  <brief_title>Hydration Sensor for Atopic Dermatitis</brief_title>
  <official_title>Validation of Skin Hydration Sensor for Atopic Dermatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pilot study of a soft, flexible hydration sensor&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Assessment of accuracy and feasibility of a skin hydration sensor at detecting differences in&#xD;
      skin hydration between skin affected by atopic dermatitis and areas not affected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 25, 2019</start_date>
  <completion_date type="Actual">February 28, 2023</completion_date>
  <primary_completion_date type="Actual">May 12, 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</measure>
    <time_frame>1 hour</time_frame>
    <description>Percent agreement between experimental sensor and commercially available transepidermal water loss meter.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">172</enrollment>
  <condition>Atopic Dermatitis</condition>
  <condition>Healthy Children</condition>
  <arm_group>
    <arm_group_label>Atopic Dermatitis</arm_group_label>
    <description>Evaluate sensor performance for hydration sensing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy aged matched controls</arm_group_label>
    <description>Evaluate sensor performance for hydration sensing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hydration Sensor</intervention_name>
    <description>This device includes a hydration sensor embedded within silicone and applied to the skin with a medical grade adhesive.</description>
    <arm_group_label>Atopic Dermatitis</arm_group_label>
    <arm_group_label>Healthy aged matched controls</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy, aged matched controls or children with prior diagnosis of atopic dermatitis as&#xD;
        confirmed by clinical diagnosis by a board-certified dermatologist&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children &lt;18 years of age&#xD;
&#xD;
          -  Children with new or prior atopic dermatitis diagnosis&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Children who are healthy, aged matched controls&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals who are pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
  </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>May 2023</verification_date>
  <study_first_submitted>January 20, 2019</study_first_submitted>
  <study_first_submitted_qc>January 20, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>May 4, 2023</last_update_submitted>
  <last_update_submitted_qc>May 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</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>
  <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>
  <!-- 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/NCT03813472
org study id: SX08152018
nct id: NCT03813472
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pilot study of a soft, flexible hydration sensor
Assessment of accuracy and feasibility of a skin hydration sensor at detecting differences in
      skin hydration between skin affected by atopic dermatitis and areas not affected.
observational model: Cohort
time perspective: Prospective
measure: Percent Agreement
time frame: 1 hour
description: Percent agreement between experimental sensor and commercially available transepidermal water loss meter.
arm group label: Atopic Dermatitis
description: Evaluate sensor performance for hydration sensing.
arm group label: Healthy aged matched controls
description: Evaluate sensor performance for hydration sensing.
intervention type: Device
intervention name: Hydration Sensor
description: This device includes a hydration sensor embedded within silicone and applied to the skin with a medical grade adhesive.
arm group label: Atopic Dermatitis
arm group label: Healthy aged matched controls
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
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