<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/NCT03755830</url>
  </required_header>
  <id_info>
    <org_study_id>Dermatology 10</org_study_id>
    <nct_id>NCT03755830</nct_id>
  </id_info>
  <brief_title>Prostaglandin F2-alpha (PGF2α) in Vitiligo</brief_title>
  <official_title>Study of the Cutaneous Expression of Prostaglandin F2-alpha (PGF2α) in Vitiligo Patients: 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>
      study the cutaneous expression of PGF2α in vitiligo patients and compare it with normal&#xD;
      control subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Measurement of tissue levels of PGF2α in vitiligo patients and compare them with healthy&#xD;
      controls.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 2018</start_date>
  <completion_date type="Anticipated">July 2019</completion_date>
  <primary_completion_date type="Anticipated">July 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>Measurement of tissue levels of PGF2α in vitiligo patients and compare them with healthy controls.</measure>
    <time_frame>6 months</time_frame>
    <description>Measurement of tissue levels of PGF2α in vitiligo patients and compare them with healthy controls to study and verify the hypothesis of involvement of PGF2α in the pathogenesis of vitiligo.• Skin biopsy for assessment of tissue levels of the PGF2α will be taken from both lesional and non lesional skin of patients of vitiligo and from normal skin of healthy controls. All skin biopsies are from non-sun exposed sites.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Vitiligo</condition>
  <arm_group>
    <arm_group_label>vitiligo patients</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Two skin biopsies (lesional and non-lesional) will be taken from every patient.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy controls</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A skin biopsy will be taken from each control subject.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Skin biopsy</intervention_name>
    <description>Two skin biopsies (lesional and non-lesional) will be taken from every patient. Also a skin biopsy will be taken from each control subject.</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 sexes.&#xD;
&#xD;
          -  Age &lt; 18 years old.&#xD;
&#xD;
          -  New cases or cases not receiving any medications for at least 3 months ago.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age: Patients &lt; 18 years.&#xD;
&#xD;
          -  Segmental or universal vitiligo.&#xD;
&#xD;
          -  Pregnant and lactating females.&#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>November 2018</verification_date>
  <study_first_submitted>November 25, 2018</study_first_submitted>
  <study_first_submitted_qc>November 25, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>November 25, 2018</last_update_submitted>
  <last_update_submitted_qc>November 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 28, 2018</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/NCT03755830
org study id: Dermatology 10
nct id: NCT03755830
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
study the cutaneous expression of PGF2α in vitiligo patients and compare it with normal
      control subjects.
Measurement of tissue levels of PGF2α in vitiligo patients and compare them with healthy
      controls.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Measurement of tissue levels of PGF2α in vitiligo patients and compare them with healthy controls.
time frame: 6 months
description: Measurement of tissue levels of PGF2α in vitiligo patients and compare them with healthy controls to study and verify the hypothesis of involvement of PGF2α in the pathogenesis of vitiligo.• Skin biopsy for assessment of tissue levels of the PGF2α will be taken from both lesional and non lesional skin of patients of vitiligo and from normal skin of healthy controls. All skin biopsies are from non-sun exposed sites.
arm group label: vitiligo patients
arm group type: Active Comparator
description: Two skin biopsies (lesional and non-lesional) will be taken from every patient.
arm group label: healthy controls
arm group type: Experimental
description: A skin biopsy will be taken from each control subject.
intervention type: Other
intervention name: Skin biopsy
description: Two skin biopsies (lesional and non-lesional) will be taken from every patient. Also a skin biopsy will be taken from each control subject.
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