<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/NCT01732965</url>
  </required_header>
  <id_info>
    <org_study_id>HFHS Vitiligo Phototherapy</org_study_id>
    <nct_id>NCT01732965</nct_id>
  </id_info>
  <brief_title>NB-UVB and PUVA Vitiligo Study</brief_title>
  <official_title>Prospective Open Parallel Right to Left Bilateral Study Comparing Narrowband Ultraviolet B Alone Versus Narrowband Ultraviolet B and Psoralen Plus Ultraviolet A for the Treatment of Vitiligo</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Henry Ford Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Henry Ford Health System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate if the combination of psoralen plus ultraviolet A and narrowband ultraviolet B is&#xD;
      more effective than narrowband ultraviolet B alone in the treatment of vitiligo.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Determine the quantity of repigmentation</measure>
    <time_frame>6 months</time_frame>
    <description>Determination the degree of repigmentation measured by the VASI score (Vitiligo area Scoring Index) after treating with the combination treatments (narrowband ultraviolet B and topical psoralen plus ultraviolet A) and compare it with narrowband ultraviolet B alone.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Determine the quality of repigmentation.</measure>
    <time_frame>Study initiation, 3 months and 6 months.</time_frame>
    <description>Determination of the color of repigmentation, pattern of repigmentation, and the cessation of spread of vitiligo after treating with the combination treatments (narrowband ultraviolet B and topical psoralen plus ultraviolet A) and compare it with narrowband ultraviolet B alone.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Vitiligo</condition>
  <arm_group>
    <arm_group_label>NB-UVB phototherapy</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>NB-UVB alone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>phototherapy and photochemotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NB-UVB and PUVA</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Phototherapy</intervention_name>
    <arm_group_label>NB-UVB phototherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Phototherapy and Photochemotherapy</intervention_name>
    <arm_group_label>phototherapy and photochemotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Vitiligo affecting more than 15% body surface area.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Iltefat Hamzavi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Henry Ford Dermatology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Henry Ford Dermatology</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>November 13, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 26, 2012</study_first_posted>
  <last_update_submitted>February 22, 2017</last_update_submitted>
  <last_update_submitted_qc>February 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Henry Ford Health System</investigator_affiliation>
    <investigator_full_name>Iltefat Hamzavi</investigator_full_name>
    <investigator_title>Senior Staff Physician</investigator_title>
  </responsible_party>
  <keyword>Vitiligo</keyword>
  <keyword>Phototherapy</keyword>
  <keyword>Photochemotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitiligo</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>February 16, 2022</submitted>
    <returned>April 26, 2022</returned>
    <submitted>June 14, 2023</submitted>
  </pending_results>
  <!-- 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/NCT01732965
org study id: HFHS Vitiligo Phototherapy
nct id: NCT01732965
lead sponsor: 
has dmc: No
To evaluate if the combination of psoralen plus ultraviolet A and narrowband ultraviolet B is
      more effective than narrowband ultraviolet B alone in the treatment of vitiligo.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Determine the quantity of repigmentation
time frame: 6 months
description: Determination the degree of repigmentation measured by the VASI score (Vitiligo area Scoring Index) after treating with the combination treatments (narrowband ultraviolet B and topical psoralen plus ultraviolet A) and compare it with narrowband ultraviolet B alone.
measure: Determine the quality of repigmentation.
time frame: Study initiation, 3 months and 6 months.
description: Determination of the color of repigmentation, pattern of repigmentation, and the cessation of spread of vitiligo after treating with the combination treatments (narrowband ultraviolet B and topical psoralen plus ultraviolet A) and compare it with narrowband ultraviolet B alone.
arm group label: NB-UVB phototherapy
arm group type: Placebo Comparator
description: NB-UVB alone
arm group label: phototherapy and photochemotherapy
arm group type: Experimental
description: NB-UVB and PUVA
intervention type: Other
intervention name: Phototherapy
arm group label: NB-UVB phototherapy
intervention type: Other
intervention name: Phototherapy and Photochemotherapy
arm group label: phototherapy and photochemotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Iltefat Hamzavi, MD
role: Principal Investigator
affiliation: Henry Ford Dermatology
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Henry Ford Health System
investigator full name: Iltefat Hamzavi
investigator title: Senior Staff Physician
mesh term: Vitiligo
submitted: February 16, 2022
returned: April 26, 2022
submitted: June 14, 2023