<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/NCT03249064</url>
  </required_header>
  <id_info>
    <org_study_id>IIBSP-VIT-2015-69</org_study_id>
    <nct_id>NCT03249064</nct_id>
  </id_info>
  <brief_title>Response to Tregs in Innate Immunity Receptor LRP1 (CD91) and Tregs in Periferic Blood Mononuclear Cells in Patients With Non-segmentary Vitiligo</brief_title>
  <official_title>Response to Tregs in Innate Immunity Receptor LRP1 (CD91) and Tregs in Periferic Blood Mononuclear Cells in Patients With Non-segmentary Vitiligo</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</source>
  <oversight_info>
    <has_dmc>Yes</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 study aims to evaluate some differences in the immune system between patients with&#xD;
      vitiligo and patients without the disease.&#xD;
&#xD;
      These differences will be evaluated by the extraction of peripheral blood that will be&#xD;
      analyzed before the treatment and after the treatment that, in the habitual way and at the&#xD;
      discretion of the responsible dermatologist.&#xD;
&#xD;
      Patients agreeing to participate in the study will be subjected to extraction of two tubes&#xD;
      (20 ml) of peripheral blood (baseline) and after 12 weeks (+/- 5 days) of treatment.&#xD;
&#xD;
      Therefore, neither treatment nor follow-up visits will be modified by participation, but will&#xD;
      be the same whether or not participate in the study.&#xD;
&#xD;
      In the case of controls, two peripheral blood tubes (20ml) will be removed in a single&#xD;
      participation.&#xD;
&#xD;
      Patients with vitiligo will also be asked to complete questionnaires to measure stress,&#xD;
      depression and perception of disease (PSS-10, Skindex-29, HADS, Likert) before and after 12&#xD;
      weeks (+/- 5 days) of therapeutic intervention .&#xD;
&#xD;
      This study will include 20 patients with active non-segmental vitiligo and 10 controls&#xD;
      without the disease. The duration of participation in this study will be 12 weeks (+/- 5&#xD;
      days) for patients with vitiligo and a single participation (extraction of 20 ml of&#xD;
      peripheral venous blood) for the controls.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 27, 2015</start_date>
  <completion_date type="Actual">September 13, 2016</completion_date>
  <primary_completion_date type="Actual">September 13, 2016</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Tregs levels</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Tregs levels</measure>
    <time_frame>16 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>LRP1 (CD91) levels</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LRP1 (CD91) levels</measure>
    <time_frame>16 weeks</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">28</enrollment>
  <condition>VITILIGO</condition>
  <arm_group>
    <arm_group_label>Vitiligo untreated patients</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Control. Patients without vitiligo</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>CD 91 levels</intervention_name>
    <arm_group_label>Control. Patients without vitiligo</arm_group_label>
    <arm_group_label>Vitiligo untreated patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Tregs</intervention_name>
    <arm_group_label>Control. Patients without vitiligo</arm_group_label>
    <arm_group_label>Vitiligo untreated patients</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Periferic blood /serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        18 to 65 years-old both sex&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Patient with vitiligo without treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with inmunosupressive disease&#xD;
&#xD;
          -  Patient receiving vitiligo treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital de la Santa Creu i Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>08025</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>August 21, 2017</last_update_submitted>
  <last_update_submitted_qc>August 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>TREGS</keyword>
  <keyword>CD91</keyword>
  <keyword>LRP1</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitiligo</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03249064
org study id: IIBSP-VIT-2015-69
nct id: NCT03249064
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aims to evaluate some differences in the immune system between patients with
      vitiligo and patients without the disease.

      These differences will be evaluated by the extraction of peripheral blood that will be
      analyzed before the treatment and after the treatment that, in the habitual way and at the
      discretion of the responsible dermatologist.

      Patients agreeing to participate in the study will be subjected to extraction of two tubes
      (20 ml) of peripheral blood (baseline) and after 12 weeks (+/- 5 days) of treatment.

      Therefore, neither treatment nor follow-up visits will be modified by participation, but will
      be the same whether or not participate in the study.

      In the case of controls, two peripheral blood tubes (20ml) will be removed in a single
      participation.

      Patients with vitiligo will also be asked to complete questionnaires to measure stress,
      depression and perception of disease (PSS-10, Skindex-29, HADS, Likert) before and after 12
      weeks (+/- 5 days) of therapeutic intervention .

      This study will include 20 patients with active non-segmental vitiligo and 10 controls
      without the disease. The duration of participation in this study will be 12 weeks (+/- 5
      days) for patients with vitiligo and a single participation (extraction of 20 ml of
      peripheral venous blood) for the controls.
observational model: Case-Control
time perspective: Prospective
measure: Tregs levels
time frame: Baseline
measure: Tregs levels
time frame: 16 weeks
measure: LRP1 (CD91) levels
time frame: Baseline
measure: LRP1 (CD91) levels
time frame: 16 weeks
arm group label: Vitiligo untreated patients
arm group label: Control. Patients without vitiligo
intervention type: Diagnostic Test
intervention name: CD 91 levels
arm group label: Control. Patients without vitiligo
arm group label: Vitiligo untreated patients
intervention type: Diagnostic Test
intervention name: Tregs
arm group label: Control. Patients without vitiligo
arm group label: Vitiligo untreated patients
Periferic blood /serum
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Vitiligo
sharing ipd: Undecided