<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/NCT03832751</url>
  </required_header>
  <id_info>
    <org_study_id>Dermatology 12</org_study_id>
    <nct_id>NCT03832751</nct_id>
  </id_info>
  <brief_title>Human Beta-defensin 1 in Vitiligo</brief_title>
  <official_title>Estimation of Tissue Level of Human Beta-defensin 1 (HBD-1) in Vitiligo Before and After Narrowband UVB Phototherapy: a Case-control Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is a need to know the role of human beta defensin-1 in vitiligo pathogenesis and the&#xD;
      probability of finding newer and effective therapy for vitiligo in the future.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 2019</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tissue levels of human beta-defensin 1 before and after NB-UVB phototherapy</measure>
    <time_frame>6 months to 1 year</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Vitiligo</condition>
  <arm_group>
    <arm_group_label>vitiligo patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tissue levels of human beta-defensin 1 in vitiligo patients before and after NB-UVB phototherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy controls</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Tissue levels of human beta-defensin 1 in healthy controls</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>skin biopsy before and after NB-UVB phototherapy</intervention_name>
    <description>skin biopsy before and after NB-UVB phototherapy to measure tissue human beta-defensin 1</description>
    <arm_group_label>Healthy controls</arm_group_label>
    <arm_group_label>vitiligo patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with non-segmental vitiligo.&#xD;
&#xD;
          -  Both genders.&#xD;
&#xD;
          -  Age more than 18 years old.&#xD;
&#xD;
          -  New cases or cases not receiving any treatment for at least 3 months prior to the&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Universal or segmental vitiligo.&#xD;
&#xD;
          -  Any contraindication to phototherapy treatment.&#xD;
&#xD;
          -  History of autoimmune diseases or other systemic diseases.&#xD;
&#xD;
          -  Any other skin disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>February 5, 2019</last_update_submitted>
  <last_update_submitted_qc>February 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Maha Fathy Elmasry</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>Vitiligo</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/NCT03832751
org study id: Dermatology 12
nct id: NCT03832751
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
There is a need to know the role of human beta defensin-1 in vitiligo pathogenesis and the
      probability of finding newer and effective therapy for vitiligo in the future.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Tissue levels of human beta-defensin 1 before and after NB-UVB phototherapy
time frame: 6 months to 1 year
arm group label: vitiligo patients
arm group type: Experimental
description: Tissue levels of human beta-defensin 1 in vitiligo patients before and after NB-UVB phototherapy
arm group label: Healthy controls
arm group type: Active Comparator
description: Tissue levels of human beta-defensin 1 in healthy controls
intervention type: Other
intervention name: skin biopsy before and after NB-UVB phototherapy
description: skin biopsy before and after NB-UVB phototherapy to measure tissue human beta-defensin 1
arm group label: Healthy controls
arm group label: vitiligo patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Maha Fathy Elmasry
investigator title: principal investigator
mesh term: Vitiligo