<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/NCT02224950</url>
  </required_header>
  <id_info>
    <org_study_id>UofMLyocell</org_study_id>
    <nct_id>NCT02224950</nct_id>
  </id_info>
  <brief_title>Study to Examine the Benefits of Fabric Made With Lyocell/Chitosan/Ceramide in the Treatment of Children With Mild to Moderate Eczema</brief_title>
  <official_title>Study to Examine the Benefits of Fabric Made With Lyocell/Chitosan/Ceramide in the Treatment of Children With Mild to Moderate Eczema</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Minnesota</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will primarily focus on evaluating the benefits of using a&#xD;
      lyocell/chitosan/ceramide fabric as a treatment for young children with mild or moderate&#xD;
      eczema. More specifically, the study will focus on the upper limb area in these patients and&#xD;
      will examine whether wearing a sleeve made from a lyocell/chitosan/ceramide fabric can&#xD;
      improve eczema symptoms compared with wearing a cotton sleeve, no sleeve, or the lyocell /&#xD;
      chitosan combination. Patients will be evaluated at 3 intervals over a 3-week period using&#xD;
      the following four variables: an eczema severity index, amount of itching, bacteria levels in&#xD;
      the affected areas of skin, and amount of water loss in the affected areas.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be evaluated using the following four variables: an eczema severity index,&#xD;
      amount/severity of itching, bacteria levels in the affected areas of skin, and amount of&#xD;
      water loss in the affected areas. The eczema severity will be scored using the EASI (upper&#xD;
      limb subscale); itch will be assessed with a Visual Analog Scale for itch; the skin will be&#xD;
      swabbed for bacterial cultures and results are quantified based on microbiology lab standards&#xD;
      to be mild, moderate or heavy growth of the bacteria identified; and transepidermal water&#xD;
      loss (TEWL) will be measured using a tewameter/capacitive moisture sensor.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Withdrawn from IRB before approval&#xD;
  </why_stopped>
  <start_date>November 2014</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Benefit of ceramide embedded fabric</measure>
    <time_frame>3 weeks</time_frame>
    <description>Whether wearing a sleeve made from a lyocell/chitosan/ceramide fabric can improve eczema symptoms compared to wearing a cotton sleeve, no sleeve, or the lyocell / chitosan combination.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bacterial growth</measure>
    <time_frame>3 weeks</time_frame>
    <description>Is bacterial growth affected by the fabric combination?</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Trans-epidermal water loss</measure>
    <time_frame>3 weeks</time_frame>
    <description>Is trans-epidermal water loss affected by the fabric combination?</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Atopic Dermatitis</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Non-medicated Emollient with no Clothing Covering Upper Limb - &quot;Baseline/Control&quot; Cells</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sleeve 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Non-medicated Emollient plus Lyocell/Chitosan Sleeve</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Sleeve</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Non-medicated Emollient plus Cotton Sleeve</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Non-medicated Emollient plus Lyocell/Chitosan Sleeve</intervention_name>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Non-medicated Emollient plus Cotton Sleeve</intervention_name>
    <arm_group_label>Sleeve 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo Sleeve</intervention_name>
    <arm_group_label>Placebo Sleeve</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 3 months to 5 years&#xD;
&#xD;
          -  Mild or moderate atopic dermatitis, as determined by Investigator Global Assessment&#xD;
             Criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-English speaking subjects/families&#xD;
&#xD;
          -  Families unable to complete study requirements&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Months</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kristen Hook, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <last_update_submitted>March 21, 2017</last_update_submitted>
  <last_update_submitted_qc>March 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Atopic dermatitis</keyword>
  <keyword>eczema</keyword>
  <keyword>alternative therapy</keyword>
  <keyword>complementary therapy</keyword>
  <keyword>moisturizer</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emollients</mesh_term>
    <mesh_term>Chitosan</mesh_term>
  </intervention_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/NCT02224950
org study id: UofMLyocell
nct id: NCT02224950
lead sponsor: 
has dmc: No
The study will primarily focus on evaluating the benefits of using a
      lyocell/chitosan/ceramide fabric as a treatment for young children with mild or moderate
      eczema. More specifically, the study will focus on the upper limb area in these patients and
      will examine whether wearing a sleeve made from a lyocell/chitosan/ceramide fabric can
      improve eczema symptoms compared with wearing a cotton sleeve, no sleeve, or the lyocell /
      chitosan combination. Patients will be evaluated at 3 intervals over a 3-week period using
      the following four variables: an eczema severity index, amount of itching, bacteria levels in
      the affected areas of skin, and amount of water loss in the affected areas.
The study will be evaluated using the following four variables: an eczema severity index,
      amount/severity of itching, bacteria levels in the affected areas of skin, and amount of
      water loss in the affected areas. The eczema severity will be scored using the EASI (upper
      limb subscale); itch will be assessed with a Visual Analog Scale for itch; the skin will be
      swabbed for bacterial cultures and results are quantified based on microbiology lab standards
      to be mild, moderate or heavy growth of the bacteria identified; and transepidermal water
      loss (TEWL) will be measured using a tewameter/capacitive moisture sensor.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Benefit of ceramide embedded fabric
time frame: 3 weeks
description: Whether wearing a sleeve made from a lyocell/chitosan/ceramide fabric can improve eczema symptoms compared to wearing a cotton sleeve, no sleeve, or the lyocell / chitosan combination.
measure: Bacterial growth
time frame: 3 weeks
description: Is bacterial growth affected by the fabric combination?
measure: Trans-epidermal water loss
time frame: 3 weeks
description: Is trans-epidermal water loss affected by the fabric combination?
arm group label: Control
arm group type: Placebo Comparator
description: Non-medicated Emollient with no Clothing Covering Upper Limb - "Baseline/Control" Cells
arm group label: Sleeve 2
arm group type: Active Comparator
description: Non-medicated Emollient plus Lyocell/Chitosan Sleeve
arm group label: Placebo Sleeve
arm group type: Placebo Comparator
description: Non-medicated Emollient plus Cotton Sleeve
intervention type: Device
intervention name: Non-medicated Emollient plus Lyocell/Chitosan Sleeve
arm group label: Control
intervention type: Other
intervention name: Non-medicated Emollient plus Cotton Sleeve
arm group label: Sleeve 2
intervention type: Other
intervention name: Placebo Sleeve
arm group label: Placebo Sleeve
criteria: 
gender: All
minimum age: 3 Months
maximum age: 5 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kristen Hook, MD
role: Principal Investigator
affiliation: University of Minnesota
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
mesh term: Emollients
mesh term: Chitosan