<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/NCT02191748</url>
  </required_header>
  <id_info>
    <org_study_id>Pro2013003377</org_study_id>
    <nct_id>NCT02191748</nct_id>
  </id_info>
  <brief_title>Assessing the Efficacy of Needling With or Without Corticosteroids in the Repigmentation of Vitiligo</brief_title>
  <official_title>Assessing the Efficacy of Needling With or Without Corticosteroids in the Repigmentation of Vitiligo</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rutgers, The State University of New Jersey</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rutgers, The State University of New Jersey</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Vitiligo is an autoimmune cutaneous disorder that destroys melanocytes leading to depigmented&#xD;
      areas of skin. In the United States, vitiligo affects 1% of patients, causing not only&#xD;
      changes in the color of skin, but also significant cosmetic concerns and quality of life&#xD;
      issues. Current treatment modalities, which include topical corticosteroids, intralesional&#xD;
      corticosteroids, phototherapy, and systemic immunosuppression, are variably effective in&#xD;
      inducing repigmentation. Unfortunately, some cases of vitiligo are refractory to treatment.&#xD;
      There is a need for new, effective modalities to treat patients with otherwise refractory&#xD;
      vitiligo.&#xD;
&#xD;
      Needling is an office based procedure that theoretically transposes healthy, pigmented skin&#xD;
      cells to depigmented areas using a needle in vitiligo patients. Two preliminary studies of&#xD;
      needling as a novel treatment for vitiligo had promising results but were limited by small&#xD;
      sample size and subjective results.&#xD;
&#xD;
      The proposed randomized control trial (RCT) will further investigate the use of needling to&#xD;
      treat vitiligo. It differs from the previous studies in that it seeks to identify the cause&#xD;
      of clinical benefit by comparing needling alone to needling with corticosteroid, examines a&#xD;
      larger number of patients, and quantifies improvement using confocal microscopy. Confocal&#xD;
      microscopy (CFM) allows non-invasive visualization of the skin on a cellular level and has&#xD;
      been used in the past to diagnose cutaneous pigmentary conditions. This study would be the&#xD;
      first RCT of needling in vitiligo to use an objective measure to quantify results, thus has&#xD;
      the potential to establish needling as a novel, effective treatment for vitiligo and to&#xD;
      evaluate the utility of CFM for monitoring response to treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Principal investigator made the decision to close study and not submit a renewal. Lack of fixed&#xD;
    research personnel to carry out the study effectively.&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">January 2018</completion_date>
  <primary_completion_date type="Anticipated">January 2018</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Repigmentation of vitiligo patch using confocal microscopy</measure>
    <time_frame>baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Repigmentation of vitiligo patch using confocal microscopy</measure>
    <time_frame>week 4 post treatment (only if repigmentation become first apparent at this time point)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Repigmentation of vitiligo patch using confocal microscopy</measure>
    <time_frame>week 8 post treatment (only if repigmentation become first apparent at this time point</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Repigmentation of vitiligo patch using confocal microscopy</measure>
    <time_frame>week 12 post treatment (only if repigmentation become first apparent at this time point</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Repigmentation of vitiligo patch using confocal microscopy</measure>
    <time_frame>week 16 post treatment (only if repigmentation become first apparent at this time point</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Repigmentation of vitiligo patch using confocal microscopy</measure>
    <time_frame>week 20 post treatment (only if repigmentation become first apparent at this time point</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Repigmentation of vitiligo patch using confocal microscopy</measure>
    <time_frame>week 24 post treatment (only if repigmentation become first apparent at this time point</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Repigmentation of vitiligo patch using confocal microscopy</measure>
    <time_frame>week 28 post treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Photography measure to assess repigmentation</measure>
    <time_frame>baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wood's lamp to assess repigmentation</measure>
    <time_frame>baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Photography measure to assess repigmentation</measure>
    <time_frame>week 4 post treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Photography measure to assess repigmentation</measure>
    <time_frame>week 8 post treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Photography measure to assess repigmentation</measure>
    <time_frame>week 12 post treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Photography measure to assess repigmentation</measure>
    <time_frame>week 16 post treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Photography measure to assess repigmentation</measure>
    <time_frame>week 20 post treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Photography measure to assess repigmentation</measure>
    <time_frame>week 24 post treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Photography measure to assess repigmentation</measure>
    <time_frame>week 28 post treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wood's lamp to assess repigmentation</measure>
    <time_frame>week 4 post treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wood's lamp to assess repigmentation</measure>
    <time_frame>week 8 post treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wood's lamp to assess repigmentation</measure>
    <time_frame>week 12 post treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wood's lamp to assess repigmentation</measure>
    <time_frame>week 16 post treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wood's lamp to assess repigmentation</measure>
    <time_frame>week 20 post treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wood's lamp to assess repigmentation</measure>
    <time_frame>week 24 post treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wood's lamp to assess repigmentation</measure>
    <time_frame>week 28 post treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Vitiligo</condition>
  <arm_group>
    <arm_group_label>Needling</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Needling is a procedure in which a needle is inserted into normally pigmented skin on the rim of a vitiligo patch and then is pushed into the center of the patch, theoretically moving healthy, pigmented skin cells into the vitiligo patch. Saline, which doesn't affect repigmentation in vitiligo, will be injected into the patch at multiple sites spaced approximately 1 cm apart with 0.1-0.2 cc of saline injected at each site.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Needling and Triamcinolone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>During the process of needling, the needle will be attached to a syringe filled with a steroid, which is then injected into the patch, enabling delivery of the steroid directly to the affected area. Triamcinolone (concentration: 2.5 mg/cc) will be injected into the patch at multiple sites spaced approximately 1 cm apart with 0.1-0.2 cc of triamcinolone injected at each site.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No treatment will be done to these vitiligo patches as a control.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Needling</intervention_name>
    <description>Needling is a procedure in which a needle is inserted into normally pigmented skin on the rim of a vitiligo patch and then is pushed into the center of the patch, theoretically moving healthy, pigmented skin cells into the vitiligo patch.</description>
    <arm_group_label>Needling</arm_group_label>
    <arm_group_label>Needling and Triamcinolone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Triamcinolone</intervention_name>
    <description>During the process of needling, the needle will be attached to a syringe filled with a steroid, which is then injected into the patch, enabling delivery of the steroid directly to the affected area</description>
    <arm_group_label>Needling and Triamcinolone</arm_group_label>
    <other_name>Kenalog</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Patients with 3 or more localized patches of stable vitiligo&#xD;
&#xD;
          -  2. No prior treatment or had failed previous vitiligo treatments&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Unstable vitiligo&#xD;
&#xD;
          -  2. Allergic to triamcinolone&#xD;
&#xD;
          -  3. Systemic treatments&#xD;
&#xD;
          -  4. Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Babar Rao, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>RWJUH Dermatology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>RWJUH Dermatology office</name>
      <address>
        <city>Somerset</city>
        <state>New Jersey</state>
        <zip>08873</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>June 3, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>July 21, 2017</last_update_submitted>
  <last_update_submitted_qc>July 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitiligo</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Triamcinolone</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>March 14, 2019</submitted>
    <returned>April 4, 2019</returned>
    <submitted>June 24, 2019</submitted>
    <returned>July 16, 2019</returned>
    <submitted>January 21, 2021</submitted>
    <returned>February 10, 2021</returned>
    <submitted>February 11, 2021</submitted>
    <returned>March 3, 2021</returned>
    <submitted>April 12, 2021</submitted>
    <returned>May 5, 2021</returned>
  </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/NCT02191748
org study id: Pro2013003377
nct id: NCT02191748
lead sponsor: 
has dmc: No
Vitiligo is an autoimmune cutaneous disorder that destroys melanocytes leading to depigmented
      areas of skin. In the United States, vitiligo affects 1% of patients, causing not only
      changes in the color of skin, but also significant cosmetic concerns and quality of life
      issues. Current treatment modalities, which include topical corticosteroids, intralesional
      corticosteroids, phototherapy, and systemic immunosuppression, are variably effective in
      inducing repigmentation. Unfortunately, some cases of vitiligo are refractory to treatment.
      There is a need for new, effective modalities to treat patients with otherwise refractory
      vitiligo.

      Needling is an office based procedure that theoretically transposes healthy, pigmented skin
      cells to depigmented areas using a needle in vitiligo patients. Two preliminary studies of
      needling as a novel treatment for vitiligo had promising results but were limited by small
      sample size and subjective results.

      The proposed randomized control trial (RCT) will further investigate the use of needling to
      treat vitiligo. It differs from the previous studies in that it seeks to identify the cause
      of clinical benefit by comparing needling alone to needling with corticosteroid, examines a
      larger number of patients, and quantifies improvement using confocal microscopy. Confocal
      microscopy (CFM) allows non-invasive visualization of the skin on a cellular level and has
      been used in the past to diagnose cutaneous pigmentary conditions. This study would be the
      first RCT of needling in vitiligo to use an objective measure to quantify results, thus has
      the potential to establish needling as a novel, effective treatment for vitiligo and to
      evaluate the utility of CFM for monitoring response to treatment.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Repigmentation of vitiligo patch using confocal microscopy
time frame: baseline
measure: Repigmentation of vitiligo patch using confocal microscopy
time frame: week 4 post treatment (only if repigmentation become first apparent at this time point)
measure: Repigmentation of vitiligo patch using confocal microscopy
time frame: week 8 post treatment (only if repigmentation become first apparent at this time point
measure: Repigmentation of vitiligo patch using confocal microscopy
time frame: week 12 post treatment (only if repigmentation become first apparent at this time point
measure: Repigmentation of vitiligo patch using confocal microscopy
time frame: week 16 post treatment (only if repigmentation become first apparent at this time point
measure: Repigmentation of vitiligo patch using confocal microscopy
time frame: week 20 post treatment (only if repigmentation become first apparent at this time point
measure: Repigmentation of vitiligo patch using confocal microscopy
time frame: week 24 post treatment (only if repigmentation become first apparent at this time point
measure: Repigmentation of vitiligo patch using confocal microscopy
time frame: week 28 post treatment
measure: Photography measure to assess repigmentation
time frame: baseline
measure: Wood's lamp to assess repigmentation
time frame: baseline
measure: Photography measure to assess repigmentation
time frame: week 4 post treatment
measure: Photography measure to assess repigmentation
time frame: week 8 post treatment
measure: Photography measure to assess repigmentation
time frame: week 12 post treatment
measure: Photography measure to assess repigmentation
time frame: week 16 post treatment
measure: Photography measure to assess repigmentation
time frame: week 20 post treatment
measure: Photography measure to assess repigmentation
time frame: week 24 post treatment
measure: Photography measure to assess repigmentation
time frame: week 28 post treatment
measure: Wood's lamp to assess repigmentation
time frame: week 4 post treatment
measure: Wood's lamp to assess repigmentation
time frame: week 8 post treatment
measure: Wood's lamp to assess repigmentation
time frame: week 12 post treatment
measure: Wood's lamp to assess repigmentation
time frame: week 16 post treatment
measure: Wood's lamp to assess repigmentation
time frame: week 20 post treatment
measure: Wood's lamp to assess repigmentation
time frame: week 24 post treatment
measure: Wood's lamp to assess repigmentation
time frame: week 28 post treatment
arm group label: Needling
arm group type: Active Comparator
description: Needling is a procedure in which a needle is inserted into normally pigmented skin on the rim of a vitiligo patch and then is pushed into the center of the patch, theoretically moving healthy, pigmented skin cells into the vitiligo patch. Saline, which doesn't affect repigmentation in vitiligo, will be injected into the patch at multiple sites spaced approximately 1 cm apart with 0.1-0.2 cc of saline injected at each site.
arm group label: Needling and Triamcinolone
arm group type: Experimental
description: During the process of needling, the needle will be attached to a syringe filled with a steroid, which is then injected into the patch, enabling delivery of the steroid directly to the affected area. Triamcinolone (concentration: 2.5 mg/cc) will be injected into the patch at multiple sites spaced approximately 1 cm apart with 0.1-0.2 cc of triamcinolone injected at each site.
arm group label: No treatment
arm group type: No Intervention
description: No treatment will be done to these vitiligo patches as a control.
intervention type: Procedure
intervention name: Needling
description: Needling is a procedure in which a needle is inserted into normally pigmented skin on the rim of a vitiligo patch and then is pushed into the center of the patch, theoretically moving healthy, pigmented skin cells into the vitiligo patch.
arm group label: Needling
arm group label: Needling and Triamcinolone
intervention type: Drug
intervention name: Triamcinolone
description: During the process of needling, the needle will be attached to a syringe filled with a steroid, which is then injected into the patch, enabling delivery of the steroid directly to the affected area
arm group label: Needling and Triamcinolone
other name: Kenalog
criteria: 
gender: All
minimum age: 18 Years
maximum age: 89 Years
healthy volunteers: No
last name: Babar Rao, MD
role: Principal Investigator
affiliation: RWJUH Dermatology
facility: 
country: United States
responsible party type: Sponsor
mesh term: Vitiligo
mesh term: Triamcinolone
submitted: March 14, 2019
returned: April 4, 2019
submitted: June 24, 2019
returned: July 16, 2019
submitted: January 21, 2021
returned: February 10, 2021
submitted: February 11, 2021
returned: March 3, 2021
submitted: April 12, 2021
returned: May 5, 2021