<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/NCT04455906</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-P00035467</org_study_id>
    <nct_id>NCT04455906</nct_id>
  </id_info>
  <brief_title>Mechanisms of Increased Disease Severity in AD Patients With the IL-4Ra R576 Polymorphism</brief_title>
  <official_title>Mechanisms of Increased Disease Severity in AD Patients With the IL-4Ra R576 Polymorphism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston Children's Hospital</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>
      This protocol is primarily looking to see if the IL-4Ra R576 polymorphism is associated with&#xD;
      increased clinical, immunological and microbial markers of disease activity in patients with&#xD;
      Atopic dermatitis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For this study, participants ages 6-65 years, who have atopic dermatitis and don't have any&#xD;
      of the exclusion criteria will be invited to participate in the study. There will be a 1 time&#xD;
      visit where questionnaires, blood draw, skin swab and skin biopsies will be performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 30, 2020</start_date>
  <completion_date type="Anticipated">September 15, 2027</completion_date>
  <primary_completion_date type="Anticipated">March 15, 2027</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>atopic dermatitis severity</measure>
    <time_frame>baseline, only 1 time point</time_frame>
    <description>validated assessment EASI score</description>
  </primary_outcome>
  <enrollment type="Anticipated">111</enrollment>
  <condition>Atopic Dermatitis</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood, skin tape, biopsy&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        atopic dermatitis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female participants ≥6 to 65 yrs of age&#xD;
&#xD;
          2. Meet AD Standard Diagnostic Criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Enrollment in another clinical trial&#xD;
&#xD;
          2. Hypersensitivity to an agent used for the skin decolonization protocol&#xD;
&#xD;
          3. Use within 4 weeks of systemic treatment with immunosuppressive/immunomodulating drugs&#xD;
             (corticosteroids, cyclosporine, mycophenolate, JAK inhibitors, azathioprine,&#xD;
             methotrexate)&#xD;
&#xD;
          4. Phototherapy for AD within 4 weeks&#xD;
&#xD;
          5. Treatment with biologics (dupilumab, omalizumab, benralizumab, etc) within sixteen&#xD;
             weeks&#xD;
&#xD;
          6. Use of topical steroids, topical calcineurin inhibitors or crisaborale within 7 days&#xD;
&#xD;
          7. Bleach baths within 7 days of the first Visit&#xD;
&#xD;
          8. Use of oral or topical antibiotics within 21 days of the beginning of the study&#xD;
&#xD;
          9. Asthmatics receiving more than 500 μg per day of inhaled corticosteroids&#xD;
&#xD;
         10. History of (HIV, hepatitis B, hepatitis C, tuberculosis malignancy&#xD;
&#xD;
         11. Skin comorbidities that may interfere with assessments: psoriasis, cutaneous T Cell&#xD;
             lymphoma,,&#xD;
&#xD;
         12. Severe ongoing medical illnesses e.g. cardiovascular, renal disease, autoimmune&#xD;
             disease.&#xD;
&#xD;
         13. Febrile illness at time of visits&#xD;
&#xD;
         14. Suspected immune deficiency or family history of primary immunodeficiency&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Wanda Phipatanakul, MD. MS.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Children's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Amparito Cunningham, MD. MPH.</last_name>
    <phone>857-218-5336</phone>
    <email>asthma@childrens.harvad.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Conor Brockway</last_name>
    <phone>857-218-3819</phone>
    <email>conor.brockway@childrens.harvard.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amparito Cunningham</last_name>
      <phone>857-218-5336</phone>
      <email>asthma@childrens.harvard.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>June 8, 2023</last_update_submitted>
  <last_update_submitted_qc>June 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Children's Hospital</investigator_affiliation>
    <investigator_full_name>Wanda Phipatanakul</investigator_full_name>
    <investigator_title>Professor of Pediatrics, Director Asthma Research Center</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis</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/NCT04455906
org study id: IRB-P00035467
nct id: NCT04455906
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This protocol is primarily looking to see if the IL-4Ra R576 polymorphism is associated with
      increased clinical, immunological and microbial markers of disease activity in patients with
      Atopic dermatitis.
For this study, participants ages 6-65 years, who have atopic dermatitis and don't have any
      of the exclusion criteria will be invited to participate in the study. There will be a 1 time
      visit where questionnaires, blood draw, skin swab and skin biopsies will be performed.
observational model: Cohort
time perspective: Prospective
measure: atopic dermatitis severity
time frame: baseline, only 1 time point
description: validated assessment EASI score
blood, skin tape, biopsy
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 65 Years
last name: Wanda Phipatanakul, MD. MS.
role: Principal Investigator
affiliation: Boston Children's Hospital
last name: Amparito Cunningham, MD. MPH.
phone: 857-218-5336
email: asthma@childrens.harvad.edu
last name: Conor Brockway
phone: 857-218-3819
email: conor.brockway@childrens.harvard.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston Children's Hospital
investigator full name: Wanda Phipatanakul
investigator title: Professor of Pediatrics, Director Asthma Research Center
mesh term: Dermatitis