<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/NCT01701648</url>
  </required_header>
  <id_info>
    <org_study_id>LEA/VIT</org_study_id>
    <secondary_id>2009-017757-36</secondary_id>
    <nct_id>NCT01701648</nct_id>
  </id_info>
  <brief_title>Melanocyte Transplantation for Patients With Stable Vitiligo.</brief_title>
  <official_title>Phase I-II, Randomized, Intraindividually Placebo Controlled Clinical Trial, to Evaluate the Efficacy of Autologous Melanocyte Transplantion on Amniotic Membrane as a Substrate for Patients With Stable Vitiligo.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinica Universidad de Navarra, Universidad de Navarra</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Spanish Clinical Research Network - SCReN</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Clinica Universidad de Navarra, Universidad de Navarra</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Vitiligo is an acquired skin disease that significantly impacts the quality of life of&#xD;
      patients. Medical treatment of vitiligo includes the use of melanocyte transplantation but&#xD;
      the results are variable.&#xD;
&#xD;
      This single center, single blind clinical trial comparing another treatment and also no&#xD;
      treatment was designed to assess the efficacy of autologous monocyte transplantation in&#xD;
      monolayers on a substrate of amniotic membrane for the treatment of stable vitiligo. Patients&#xD;
      will receive the two interventions, melanocyte suspension and monolayer on amniotic membrane&#xD;
      and will provide an untreated area as a control.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Main Objective:&#xD;
&#xD;
      The main objective is to assess the efficacy of autologous transplantation of monocytes in&#xD;
      monolayers grown on a biological substrate of amniotic membrane in the treatment of stable&#xD;
      vitiligo. Using a system of digital imaging analysis the percentage of re-pigmentation&#xD;
      obtained will be studied after 3, 6 and 9 months of treatment.&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
      To demonstrate differences in efficacy (as measured by the percentage of re-pigmentation) of&#xD;
      each of the 2 techniques used: pure melanocytes in suspension and amniotic membrane with&#xD;
      melanocytes in monolayers.&#xD;
&#xD;
      To assess how rapidly epithelialization occurs and the cosmetic result in the short and long&#xD;
      term of the areas treated with each of the techniques.&#xD;
&#xD;
      To assess if de-epidermization with CO2 laser may be by itself a stimulus for the reservoir&#xD;
      of melanocytes in the adjacent epidermis or hair follicles or if the re-pigmentation obtained&#xD;
      with this procedure is merely postinflammatory as a result of trauma to the epidermis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2010</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of Autologous Melanocyte Transplantion on Amniotic Membrane as a Substrate for Patients With Stable Vitiligo</measure>
    <time_frame>six months</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Stable Vitiligo</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laser CO2</intervention_name>
    <description>Transplantation of autologous melanocytes using amniotic membrane as a substrate. Transplantation of suspension of autologous melanocytes.</description>
    <arm_group_label>1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  Patients must voluntarily provide informed consent before any of the tests included in&#xD;
             the trial which do not form part of standard treatment can be performed.&#xD;
&#xD;
          -  Mentally stable patients, suffering from piebaldism, vitiligo of metameric&#xD;
             distribution, focal or generalized vitiligo which has remained stable for at least one&#xD;
             year without de-pigmentation or spontaneous re-pigmentation after standard medical&#xD;
             treatment.&#xD;
&#xD;
          -  A minimum hypopigmented area to treat of 100 cm2 (at least 30 cm2 for each of the&#xD;
             therapeutic options).&#xD;
&#xD;
          -  For women of child-bearing age, a negative pregnancy test.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Women who are pregnant or breast-feeding.&#xD;
&#xD;
          -  Positive results in any of the blood tests given&#xD;
&#xD;
          -  Concomitant serious illness.&#xD;
&#xD;
          -  Patients who have received any agent currently the focus of research in the 30 days&#xD;
             prior to their inclusion.&#xD;
&#xD;
          -  Patients currently participating in another clinical trial or receiving any other&#xD;
             agent currently the focus of research.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Clinic of Navarre</name>
      <address>
        <city>Pamplona</city>
        <state>Navarre</state>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>September 2013</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <last_update_submitted>October 11, 2013</last_update_submitted>
  <last_update_submitted_qc>October 11, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 14, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Vitiligo, amniotic membrane, malanocytes, C02 laser.</keyword>
  <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/NCT01701648
org study id: LEA/VIT
secondary id: 2009-017757-36
nct id: NCT01701648
lead sponsor: 
collaborator: 
has dmc: No
Vitiligo is an acquired skin disease that significantly impacts the quality of life of
      patients. Medical treatment of vitiligo includes the use of melanocyte transplantation but
      the results are variable.

      This single center, single blind clinical trial comparing another treatment and also no
      treatment was designed to assess the efficacy of autologous monocyte transplantation in
      monolayers on a substrate of amniotic membrane for the treatment of stable vitiligo. Patients
      will receive the two interventions, melanocyte suspension and monolayer on amniotic membrane
      and will provide an untreated area as a control.
Main Objective:

      The main objective is to assess the efficacy of autologous transplantation of monocytes in
      monolayers grown on a biological substrate of amniotic membrane in the treatment of stable
      vitiligo. Using a system of digital imaging analysis the percentage of re-pigmentation
      obtained will be studied after 3, 6 and 9 months of treatment.

      Secondary Objectives:

      To demonstrate differences in efficacy (as measured by the percentage of re-pigmentation) of
      each of the 2 techniques used: pure melanocytes in suspension and amniotic membrane with
      melanocytes in monolayers.

      To assess how rapidly epithelialization occurs and the cosmetic result in the short and long
      term of the areas treated with each of the techniques.

      To assess if de-epidermization with CO2 laser may be by itself a stimulus for the reservoir
      of melanocytes in the adjacent epidermis or hair follicles or if the re-pigmentation obtained
      with this procedure is merely postinflammatory as a result of trauma to the epidermis.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Efficacy of Autologous Melanocyte Transplantion on Amniotic Membrane as a Substrate for Patients With Stable Vitiligo
time frame: six months
arm group label: 1
arm group type: Active Comparator
intervention type: Other
intervention name: Laser CO2
description: Transplantation of autologous melanocytes using amniotic membrane as a substrate. Transplantation of suspension of autologous melanocytes.
arm group label: 1
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Vitiligo