<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/NCT03270241</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00133884</org_study_id>
    <nct_id>NCT03270241</nct_id>
  </id_info>
  <brief_title>Early Molecular Changes in Vitiligo After Narrowband Ultraviolet Therapy</brief_title>
  <official_title>Early Molecular Changes in Vitiligo After Narrowband Ultraviolet Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Vitiligo is a chronic acquired cutaneous disease of pigmentation that affects patients'&#xD;
      quality of life across all degrees of involvement and severity. Phototherapy, such as Narrow&#xD;
      band UVB (NB-UVB), is a clinically indicated treatment for skin lesions. NB-UVB treatment has&#xD;
      been shown to promote repigmentation and normalize cellular behaviors. The investigators&#xD;
      would like to analyze the change in protein expression and histological change in skin from&#xD;
      NB-UVB treatment in participants with Vitiligo.&#xD;
&#xD;
      The investigators are recruiting participants with Vitiligo on the body, arms, and/or legs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a dermatology study of the effects of short-term NB-UVB treatment, standard&#xD;
      phototherapy for Vitiligo patients. In the study, demographics information, three ascending&#xD;
      dose of phototherapy, and small skin biopsies will be required of the participants.&#xD;
&#xD;
      For all enrolled participants, the starting dose of NB-UVB administered will be 250 mJ/cm2,&#xD;
      which is the standard of care for patients with Vitiligo. The dose will be increased by 10%&#xD;
      with each treatment, as long as there are no side effects with treatment such as burning or&#xD;
      redness/ erythema. Small skin biopsies will be collected from normal skin and from affected&#xD;
      skin from vitiligo participants at the baseline visit and 3 days after the conclusion of&#xD;
      treatment; up to a total of 6 biopsies will be collected from each patient. Participants will&#xD;
      be compensated for time and effort.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">March 14, 2023</completion_date>
  <primary_completion_date type="Actual">March 14, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Participants diagnosed with Vitiligo who are enrolled in the study will receive phototherapy (NB-UVB), with the starting dose of 250 mJ/cm2. The dose will be increased by 10% with each treatment. Small skin samples will be collected before and after NB-UVB treatment.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Molecular changes from NB-UVB therapy</measure>
    <time_frame>2 years</time_frame>
    <description>The investigators are assessing the histological and molecular changes of normal and Vitiligo-lesion skin from NB-UVB therapy. The molecular markers (in microgram/ mL) include, but not limited to, KIT receptor, stem cell factor (SCF), tumor necrosis factor-alpha (TNF-alpha), and interleukin-1 (IL-1).</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Vitiligo</condition>
  <condition>Dermatology/Skin - Other</condition>
  <arm_group>
    <arm_group_label>Phototherapy (NB-UVB)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Phototherapy (NB-UVB) will be administered for all enrolled subjects. The starting dosage will be 250 mJ/cm2. The dose will be increased by 10% with each treatment, as long as there are no side effects with treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Phototherapy (NB-UVB) via the 3 Series PC &amp; SP phototherapy cabinet</intervention_name>
    <description>This is an investigator-initiated, single-blinded, ascending dose study of NB-UVB treatment for Vitiligo in adults of 3 treatments for one week. It is designed to measure the molecular changes and re-pigmentation in affected and normal skin of participants with Vitiligo and normal skin in healthy participants.</description>
    <arm_group_label>Phototherapy (NB-UVB)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults 18 years or older with bilateral symmetrical vitiligo lesions, in general good&#xD;
             health as determined by the Principal Investigator by medical history and physical&#xD;
             exam.&#xD;
&#xD;
          -  Able to understand consent procedure&#xD;
&#xD;
          -  Able to comply with protocol activities&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients less than 18 years old&#xD;
&#xD;
          -  Patients not able to understand consent procedure&#xD;
&#xD;
          -  Patients unable to comply with protocol activities&#xD;
&#xD;
          -  Non-English speakers: the study assessments/questionnaires/evaluations are not&#xD;
             scientifically validated in languages other than English.&#xD;
&#xD;
          -  Patients with a photosensitive disorder or on a medication which has been demonstrated&#xD;
             in these patients to cause photosensitivity&#xD;
&#xD;
          -  Patients receiving concomitant phototherapy to test sites&#xD;
&#xD;
          -  Patient receiving topical medication to test sites within 2 weeks of study initiation&#xD;
&#xD;
          -  Patient receiving oral medications for vitiligo within 4 weeks prior to study&#xD;
             initiation&#xD;
&#xD;
          -  Receipt of an investigation agent within the past 4 weeks (or within 5 half lives)&#xD;
             prior to study initiation&#xD;
&#xD;
          -  Pregnant or nursing patients (self-reported)&#xD;
&#xD;
          -  Patient with significant medical history or concurrent illness that the investigator&#xD;
             feels is not safe for study participation, including melanoma&#xD;
&#xD;
          -  Presence or suspicion of bleeding disorder or diathesis which would complicate biopsy.&#xD;
&#xD;
          -  Patients with history of excessive scar or keloid formation in the past 10 years&#xD;
&#xD;
          -  Patients with known allergy to anesthetic used&#xD;
&#xD;
          -  Subjects with a pacemaker, implanted cardioverter-defibrillator, baroreflex activation&#xD;
             device, cochlear implant, implanted bone growth stimulator, robotic limb prosthesis,&#xD;
             subcutaneous GPS tracking device, electrodes implanted in the brain, attached&#xD;
             electrodes in a subject undergoing cardiac defibrillation during the moment of skin&#xD;
             color reading, or other device which may be disrupted by electrical current, UNLESS&#xD;
             subject is kept &quot;1 yard (one arm's length) from the main unit&quot; of the&#xD;
             spectrophotometer at all times, as specified in device approval letter.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Noori Kim, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins Outpatient Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>July 13, 2023</last_update_submitted>
  <last_update_submitted_qc>July 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Vitiligo</keyword>
  <keyword>Dermatology</keyword>
  <keyword>Johns Hopkins</keyword>
  <keyword>Compensation</keyword>
  <keyword>Paid</keyword>
  <keyword>Phototherapy</keyword>
  <keyword>NB-UVB</keyword>
  <keyword>Light treatment</keyword>
  <keyword>Skin</keyword>
  <keyword>Biopsies</keyword>
  <keyword>Money</keyword>
  <keyword>Short-term</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>
    <ipd_description>The investigators are still deciding on what information to release to other researchers.</ipd_description>
  </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/NCT03270241
org study id: IRB00133884
nct id: NCT03270241
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Vitiligo is a chronic acquired cutaneous disease of pigmentation that affects patients'
      quality of life across all degrees of involvement and severity. Phototherapy, such as Narrow
      band UVB (NB-UVB), is a clinically indicated treatment for skin lesions. NB-UVB treatment has
      been shown to promote repigmentation and normalize cellular behaviors. The investigators
      would like to analyze the change in protein expression and histological change in skin from
      NB-UVB treatment in participants with Vitiligo.

      The investigators are recruiting participants with Vitiligo on the body, arms, and/or legs.
This is a dermatology study of the effects of short-term NB-UVB treatment, standard
      phototherapy for Vitiligo patients. In the study, demographics information, three ascending
      dose of phototherapy, and small skin biopsies will be required of the participants.

      For all enrolled participants, the starting dose of NB-UVB administered will be 250 mJ/cm2,
      which is the standard of care for patients with Vitiligo. The dose will be increased by 10%
      with each treatment, as long as there are no side effects with treatment such as burning or
      redness/ erythema. Small skin biopsies will be collected from normal skin and from affected
      skin from vitiligo participants at the baseline visit and 3 days after the conclusion of
      treatment; up to a total of 6 biopsies will be collected from each patient. Participants will
      be compensated for time and effort.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Participants diagnosed with Vitiligo who are enrolled in the study will receive phototherapy (NB-UVB), with the starting dose of 250 mJ/cm2. The dose will be increased by 10% with each treatment. Small skin samples will be collected before and after NB-UVB treatment.
primary purpose: Treatment
masking: None (Open Label)
measure: Molecular changes from NB-UVB therapy
time frame: 2 years
description: The investigators are assessing the histological and molecular changes of normal and Vitiligo-lesion skin from NB-UVB therapy. The molecular markers (in microgram/ mL) include, but not limited to, KIT receptor, stem cell factor (SCF), tumor necrosis factor-alpha (TNF-alpha), and interleukin-1 (IL-1).
arm group label: Phototherapy (NB-UVB)
arm group type: Experimental
description: Phototherapy (NB-UVB) will be administered for all enrolled subjects. The starting dosage will be 250 mJ/cm2. The dose will be increased by 10% with each treatment, as long as there are no side effects with treatment.
intervention type: Device
intervention name: Phototherapy (NB-UVB) via the 3 Series PC & SP phototherapy cabinet
description: This is an investigator-initiated, single-blinded, ascending dose study of NB-UVB treatment for Vitiligo in adults of 3 treatments for one week. It is designed to measure the molecular changes and re-pigmentation in affected and normal skin of participants with Vitiligo and normal skin in healthy participants.
arm group label: Phototherapy (NB-UVB)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Noori Kim, M.D
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Vitiligo
sharing ipd: Undecided
ipd description: The investigators are still deciding on what information to release to other researchers.