xml: <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/NCT06035614</url>
    </required_header>
    <id_info>
      <org_study_id>000001112022</org_study_id>
      <nct_id>NCT06035614</nct_id>
    </id_info>
    <brief_title>Efficacy and Safety of 308-nm Excimer Lamp Combined With Tacrolimus vs Tacrolimus as Monotherapy in Treating Vitiligo on Children</brief_title>
    <official_title>Efficacy and Safety of 308-nm Excimer Lamp Combined With Tacrolimus vs Tacrolimus as Monotherapy in Treating Vitiligo on Children</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Clarteis</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Clarteis</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Vitiligo is a auto immune that impact 2% of the global population, regardless from the&#xD;
        phototype. Even though it affects patients in a physical way through loss of pigmentation, it&#xD;
        is also impacting them on a mental/emotional way.11-12 Current treatments offer a symptomatic&#xD;
        solution to patients, however the response rate can be low and results can be slow.&#xD;
  &#xD;
        Pediatric patients in vitiligo deserves special care as frequently (50%), the disease onset&#xD;
        is before 20 years of age and, in 25% of the cases, it starts before the age of 10 years.13&#xD;
        Also, the current treatments for children are limited since it can involve pain and&#xD;
        claustrophobia. The combination therapy of the study could offer a painless and easy&#xD;
        treatment to follow.&#xD;
  &#xD;
        If the combination of those two therapies can fasten and improve the response rate, this&#xD;
        could be a good option to treat this condition not only in children, but also for adults&#xD;
        patients.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">October 1, 2022</start_date>
    <completion_date type="Actual">July 1, 2023</completion_date>
    <primary_completion_date type="Actual">May 1, 2023</primary_completion_date>
    <phase>N/A</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>repigmentation rate</measure>
      <time_frame>1,2,3 and 4 months</time_frame>
      <description>Baseline, photos will be taken and the exact sites involved will be recorded. The clinical improvement measured by the percentage of repigmentation will be assessed and compared between the two mentioned groups at 1,2, 3 and 4 months.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">50</enrollment>
    <condition>Vitiligo</condition>
    <condition>Pediatric ALL</condition>
    <condition>Dermatologic Disease</condition>
    <condition>Autoimmune Diseases</condition>
    <arm_group>
      <arm_group_label>Tacrolimus + excimer light (group A)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>group A, will be treated by Tacrolimus 0.1% ointment twice daily and excimer light 308nm twice weekly (exciplex®)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Tacrolimus (group B)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>group B will start on Tacrolimus 0.1% ointment twice daily alone</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>exciplex</intervention_name>
      <description>exciplex, excimer lamp 308nm produced by clarteis</description>
      <arm_group_label>Tacrolimus + excimer light (group A)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Tacrolimus ointment</intervention_name>
      <description>tacrolimus monohydrate ointment 0.1% TACRUS</description>
      <arm_group_label>Tacrolimus (group B)</arm_group_label>
      <arm_group_label>Tacrolimus + excimer light (group A)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  vitiligo and surface area involved of less than10% who are being followed in the&#xD;
               outpatient dermatology clinics of King Abdullah University Hospital (KAUH)&#xD;
  &#xD;
            -  6 weeks wash out period from previous treatments will be employed to eliminate any&#xD;
               effect from such treatments&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Skin dermatoses with Kobner phenomenon&#xD;
  &#xD;
            -  Lupus erythematous&#xD;
  &#xD;
            -  Pacemakers&#xD;
  &#xD;
            -  Hyper-photosensitivity&#xD;
  &#xD;
            -  Melanoma and non-melanoma skin cancers&#xD;
  &#xD;
            -  Drugs with photosensitizer side effect&#xD;
  &#xD;
            -  Radiotherapy&#xD;
  &#xD;
            -  Pregnancy (by principle, nno study available)&#xD;
  &#xD;
            -  Diseases that are contagious by contact&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>4 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>King Abdullah University Hospital</name>
        <address>
          <city>Ar Ramthā</city>
          <zip>21410</zip>
          <country>Jordan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Jordan</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>October 24, 2022</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>vitiligo</keyword>
    <keyword>excimer</keyword>
    <keyword>308nm</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vitiligo</mesh_term>
      <mesh_term>Skin Diseases</mesh_term>
      <mesh_term>Autoimmune Diseases</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tacrolimus</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06035614
  org study id: 000001112022
  nct id: NCT06035614
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Vitiligo is a auto immune that impact 2% of the global population, regardless from the
        phototype. Even though it affects patients in a physical way through loss of pigmentation, it
        is also impacting them on a mental/emotional way.11-12 Current treatments offer a symptomatic
        solution to patients, however the response rate can be low and results can be slow.
  
        Pediatric patients in vitiligo deserves special care as frequently (50%), the disease onset
        is before 20 years of age and, in 25% of the cases, it starts before the age of 10 years.13
        Also, the current treatments for children are limited since it can involve pain and
        claustrophobia. The combination therapy of the study could offer a painless and easy
        treatment to follow.
  
        If the combination of those two therapies can fasten and improve the response rate, this
        could be a good option to treat this condition not only in children, but also for adults
        patients.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: repigmentation rate
  time frame: 1,2,3 and 4 months
  description: Baseline, photos will be taken and the exact sites involved will be recorded. The clinical improvement measured by the percentage of repigmentation will be assessed and compared between the two mentioned groups at 1,2, 3 and 4 months.
  arm group label: Tacrolimus + excimer light (group A)
  arm group type: Active Comparator
  description: group A, will be treated by Tacrolimus 0.1% ointment twice daily and excimer light 308nm twice weekly (exciplex®)
  arm group label: Tacrolimus (group B)
  arm group type: Active Comparator
  description: group B will start on Tacrolimus 0.1% ointment twice daily alone
  intervention type: Device
  intervention name: exciplex
  description: exciplex, excimer lamp 308nm produced by clarteis
  arm group label: Tacrolimus + excimer light (group A)
  intervention type: Drug
  intervention name: Tacrolimus ointment
  description: tacrolimus monohydrate ointment 0.1% TACRUS
  arm group label: Tacrolimus (group B)
  arm group label: Tacrolimus + excimer light (group A)
  criteria: 
  gender: All
  minimum age: 4 Years
  maximum age: 18 Years
  healthy volunteers: No
  facility: 
  country: Jordan
  responsible party type: Sponsor
  mesh term: Vitiligo
  mesh term: Skin Diseases
  mesh term: Autoimmune Diseases
  mesh term: Tacrolimus
  sharing ipd: No