<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/NCT04440371</url>
  </required_header>
  <id_info>
    <org_study_id>21/104/2017</org_study_id>
    <nct_id>NCT04440371</nct_id>
  </id_info>
  <brief_title>Phototherapy Combination With Topicals in Vitiligo</brief_title>
  <acronym>NBUVB</acronym>
  <official_title>Comparison of the Efficacy of Tacrolimus 0.1% Ointment vs Calcipotriol/Betamethasone in Combination With NBUVB in Treatment of Vitiligo</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jordan University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jordan University of Science and Technology</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>
      Patients will be included in a randomized controlled clinical trial, will enroll only adult&#xD;
      vitiligo patients with surface area of at least 10% who are being followed in the outpatient&#xD;
      dermatology clinics of King Abdullah University Hospital (KAUH) and are planned to start on&#xD;
      phototherapy Narrow Band Ultraviolet light B (NBUVB), regardless if they have previous&#xD;
      treatment for their disease, one month wash off period will be given for patients who are&#xD;
      already on phototherapy or other treatments for vitiligo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients to be included in this randomized controlled study are adults with generalized&#xD;
      vitiligo of surface area of at least 10% who are being followed in the outpatient dermatology&#xD;
      clinics of King Abdullah University Hospital (KAUH) and are planned to start on phototherapy&#xD;
      Narrow Band Ultraviolet light B (NB-UVB), regardless if they have previous treatment for&#xD;
      their disease, one month wash off period will be given for patients who are already on&#xD;
      phototherapy or other treatments for vitiligo. In our going study, adult patients will be&#xD;
      enrolled into 2 groups ( around 20 patients per each) in which NBUVB will be given 2-3&#xD;
      sessions per week in combination with one of the following randomly; one group will start on&#xD;
      Tacrolimus 0.1% ointment twice daily, a second group will start on calcipotriol &amp;&#xD;
      betamethasone containing cream once daily, photos will be taken and the exact sites involved&#xD;
      will be detected, efficacy of treatment will be assessed according to repigmentation&#xD;
      percentages of vitiligo areas from baseline at 3 and 6 months. The improvement at 6 months&#xD;
      compared to baseline will be classified into 5 groups according to the percentage of&#xD;
      repigmentation as follow; excellent (76%-100%); moderate (51%-75%); mild (26%-50%); minimal&#xD;
      (1%-25%); or no response.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 21, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 30, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>efficacy of treatment</measure>
    <time_frame>Baseline: measurement of vitiligo BSA with photographs of vitiligo areas. lab investigations done at this stage</time_frame>
    <description>The area of vitiligo will be measured using body surface area (BSA) at baseline. the difference in BSA will represent the improvement from baseline. Patient palm will be used for estimation of BSA at each visit (Each one plam is equivalent to 1% of BSA). Photographs will be taken .</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy of treatment</measure>
    <time_frame>3 months post treatment</time_frame>
    <description>The area of vitiligo will be measured using body surface area (BSA) at 3 months. the difference in BSA will represent the improvement from baseline. Patient palm will be used for estimation of BSA at each visit (Each one plam is equivalent to 1% of BSA). Photographs will be taken.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy of treatment</measure>
    <time_frame>6 months post treatment</time_frame>
    <description>The area of vitiligo will be measured using body surface area (BSA). the difference in BSA will represent the improvement from baseline. Patient palm will be used for estimation of BSA at each visit (Each one plam is equivalent to 1% of BSA). Photographs will be taken.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Vitiligo, Generalized</condition>
  <arm_group>
    <arm_group_label>Tacrolimus</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Phototherapy NBUVB will be given 3 times per week and Tacrolimus 0.1% ointment will be applied twice a day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>calcipotriol / betamethasone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Phototherapy NBUVB will be given 3 times per week and calcipotriol &amp; betamethasone containing cream will be applied once a day</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Tacrolimus 0.1% ointment twice daily plus NBUVB 3 times weekly</intervention_name>
    <description>Tacrolimus ointment plus phototherapy NBUVB (Tacrolimus arm)</description>
    <arm_group_label>Tacrolimus</arm_group_label>
    <arm_group_label>calcipotriol / betamethasone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Calcipotriol/Betamethasone ointment plus NBUVB</intervention_name>
    <description>Calcipotriol/Betamethasone ointment once daily plus NBUVB 3 times weekly</description>
    <arm_group_label>Tacrolimus</arm_group_label>
    <arm_group_label>calcipotriol / betamethasone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Adult patients ( ≥ 18 years).&#xD;
&#xD;
          -  Diagnosed with vitiligo clinically and by using wood's light&#xD;
&#xD;
          -  Generalized type vitiligo and BSA ≥ 10%&#xD;
&#xD;
          -  Planned by his physician to start on phototherapy&#xD;
&#xD;
          -  Wash off period for patients on treatment of one month duration.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Children less than 18 year old&#xD;
&#xD;
          -  Localized type vitiligo or BSA less than 10%&#xD;
&#xD;
          -  Unable to do phototherapy&#xD;
&#xD;
          -  Pregnant women with vitiligo&#xD;
&#xD;
          -  Previously failed to response to phototherapy&#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>Diala Alshiyab, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jordan University of Science and Technology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Diala Alshiyab</name>
      <address>
        <city>Irbid</city>
        <country>Jordan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Jordan</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>September 10, 2022</last_update_submitted>
  <last_update_submitted_qc>September 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2022</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>Betamethasone</mesh_term>
    <mesh_term>Calcipotriene</mesh_term>
    <mesh_term>Tacrolimus</mesh_term>
  </intervention_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/NCT04440371
org study id: 21/104/2017
nct id: NCT04440371
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Patients will be included in a randomized controlled clinical trial, will enroll only adult
      vitiligo patients with surface area of at least 10% who are being followed in the outpatient
      dermatology clinics of King Abdullah University Hospital (KAUH) and are planned to start on
      phototherapy Narrow Band Ultraviolet light B (NBUVB), regardless if they have previous
      treatment for their disease, one month wash off period will be given for patients who are
      already on phototherapy or other treatments for vitiligo.
Patients to be included in this randomized controlled study are adults with generalized
      vitiligo of surface area of at least 10% who are being followed in the outpatient dermatology
      clinics of King Abdullah University Hospital (KAUH) and are planned to start on phototherapy
      Narrow Band Ultraviolet light B (NB-UVB), regardless if they have previous treatment for
      their disease, one month wash off period will be given for patients who are already on
      phototherapy or other treatments for vitiligo. In our going study, adult patients will be
      enrolled into 2 groups ( around 20 patients per each) in which NBUVB will be given 2-3
      sessions per week in combination with one of the following randomly; one group will start on
      Tacrolimus 0.1% ointment twice daily, a second group will start on calcipotriol &
      betamethasone containing cream once daily, photos will be taken and the exact sites involved
      will be detected, efficacy of treatment will be assessed according to repigmentation
      percentages of vitiligo areas from baseline at 3 and 6 months. The improvement at 6 months
      compared to baseline will be classified into 5 groups according to the percentage of
      repigmentation as follow; excellent (76%-100%); moderate (51%-75%); mild (26%-50%); minimal
      (1%-25%); or no response.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: efficacy of treatment
time frame: Baseline: measurement of vitiligo BSA with photographs of vitiligo areas. lab investigations done at this stage
description: The area of vitiligo will be measured using body surface area (BSA) at baseline. the difference in BSA will represent the improvement from baseline. Patient palm will be used for estimation of BSA at each visit (Each one plam is equivalent to 1% of BSA). Photographs will be taken .
measure: Efficacy of treatment
time frame: 3 months post treatment
description: The area of vitiligo will be measured using body surface area (BSA) at 3 months. the difference in BSA will represent the improvement from baseline. Patient palm will be used for estimation of BSA at each visit (Each one plam is equivalent to 1% of BSA). Photographs will be taken.
measure: Efficacy of treatment
time frame: 6 months post treatment
description: The area of vitiligo will be measured using body surface area (BSA). the difference in BSA will represent the improvement from baseline. Patient palm will be used for estimation of BSA at each visit (Each one plam is equivalent to 1% of BSA). Photographs will be taken.
arm group label: Tacrolimus
arm group type: Active Comparator
description: Phototherapy NBUVB will be given 3 times per week and Tacrolimus 0.1% ointment will be applied twice a day
arm group label: calcipotriol / betamethasone
arm group type: Active Comparator
description: Phototherapy NBUVB will be given 3 times per week and calcipotriol & betamethasone containing cream will be applied once a day
intervention type: Combination Product
intervention name: Tacrolimus 0.1% ointment twice daily plus NBUVB 3 times weekly
description: Tacrolimus ointment plus phototherapy NBUVB (Tacrolimus arm)
arm group label: Tacrolimus
arm group label: calcipotriol / betamethasone
intervention type: Combination Product
intervention name: Calcipotriol/Betamethasone ointment plus NBUVB
description: Calcipotriol/Betamethasone ointment once daily plus NBUVB 3 times weekly
arm group label: Tacrolimus
arm group label: calcipotriol / betamethasone
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Diala Alshiyab, MD
role: Principal Investigator
affiliation: Jordan University of Science and Technology
facility: 
country: Jordan
responsible party type: Sponsor
mesh term: Vitiligo
mesh term: Betamethasone
mesh term: Calcipotriene
mesh term: Tacrolimus