xml: <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/NCT05980390</url>
    </required_header>
    <id_info>
      <org_study_id>IL35 in vitiligo</org_study_id>
      <nct_id>NCT05980390</nct_id>
    </id_info>
    <brief_title>IL35 Level in Vitiligo</brief_title>
    <official_title>Assessment of Tissue Levels of IL-35 in Active and Stable Vitiligo</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>
        The aim of this observational study is to evaluate the level of the IL-35 protein in tissue&#xD;
        biopsy from patients with active &amp; stable vitiligo.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 10, 2023</start_date>
    <completion_date type="Anticipated">October 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>level of IL35 in tissue biopsy</measure>
      <time_frame>3 months</time_frame>
    </primary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">84</enrollment>
    <condition>IL35, Vitiligo</condition>
    <arm_group>
      <arm_group_label>Active vitiligo</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Stable vitiligo</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Normal controls</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>IL 35 in tissue biopsy</intervention_name>
      <description>Elisa testing</description>
      <arm_group_label>Active vitiligo</arm_group_label>
      <arm_group_label>Normal controls</arm_group_label>
      <arm_group_label>Stable vitiligo</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with active and stable vitiligo together with normal subjects&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with active and stable vitiligo&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant and lactating women.&#xD;
  &#xD;
            -  Patients with associated autoimmune or other dermatological diseases e.g., Alopecia&#xD;
               areata and lupus erythematous.&#xD;
  &#xD;
            -  Patients already on both topical and systemic treatment at the time of recruitment.&#xD;
  &#xD;
            -  Patients on Immunosuppressive drugs.&#xD;
  &#xD;
            -  Other hypopigmented diseases such as pityriasis alba, tinea versicolor, lichen&#xD;
               sclerosis, post inflammatory hypopigmentation and leprosy as excluded by lack of&#xD;
               accentuation by wood's light examination.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
    </eligibility>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Hagar El Sayed</investigator_full_name>
      <investigator_title>Dr</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>
  
  
text: 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/NCT05980390
  org study id: IL35 in vitiligo
  nct id: NCT05980390
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this observational study is to evaluate the level of the IL-35 protein in tissue
        biopsy from patients with active & stable vitiligo.
  observational model: Case-Control
  time perspective: Cross-Sectional
  measure: level of IL35 in tissue biopsy
  time frame: 3 months
  arm group label: Active vitiligo
  arm group label: Stable vitiligo
  arm group label: Normal controls
  intervention type: Diagnostic Test
  intervention name: IL 35 in tissue biopsy
  description: Elisa testing
  arm group label: Active vitiligo
  arm group label: Normal controls
  arm group label: Stable vitiligo
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Hagar El Sayed
  investigator title: Dr
  mesh term: Vitiligo