<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/NCT03247400</url>
  </required_header>
  <id_info>
    <org_study_id>NCU 631</org_study_id>
    <nct_id>NCT03247400</nct_id>
  </id_info>
  <brief_title>The Evaluation of Vitiligous Lesions Repigmentation After the Administration of Atorvastatin Calcium Salt and Simvastatin-acid Sodium Salt in Patients With Active Vitiligo</brief_title>
  <acronym>EVRAAS</acronym>
  <official_title>The Evaluation of Vitiligous Lesions Repigmentation After the Administration of Atorvastatin Calcium Salt and Simvastatin-acid Sodium Salt in Patients With Active Vitiligo (EVRAAS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nicolaus Copernicus University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nicolaus Copernicus University</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate the influence of simvastatin and atorvastatin on&#xD;
      vitiligous lesions in patients with non-segmental vitiligo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      According to available data, statins act through several immunological pathways, potentially&#xD;
      reversing undesirable phenomena underlying autoimmune vitiligo pathogenesis. A study has been&#xD;
      designed as a single-center, randomized, double-blind, placebo-controlled pilot study with&#xD;
      the enrollment of at least 20 active non-segmental vitiligo patients presenting with&#xD;
      vitiligous lesions on both upper and lower limbs. Clinical effects of ointments containing 1%&#xD;
      simvastatin-acid sodium salt or 1% atorvastatin calcium salt applied on a preselected limb&#xD;
      will be assessed in comparison with vehicle ointment applied on the opposite limb. All study&#xD;
      participants will undergo clinical evaluation using Body Surface Area (BSA) and Vitiligo Area&#xD;
      Scoring Index (VASI) scales at baseline, week 4, week 8 and week 12 time points. Precise&#xD;
      assessment of skin lesions will be performed using photographic documentation obtained during&#xD;
      each study visit and processed with NIS-Elements software.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2016</start_date>
  <completion_date type="Actual">April 30, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>evaluation of repigmentation of vitiligous lesions achieved after the administration of 1% simvastatin-acid sodium salt or 1% atorvastatin calcium salt ointments compared to vehicle ointments after a 12-week study period.</measure>
    <time_frame>12 weeks</time_frame>
    <description>change from baseline in repigmentation on BSA and VASI scale at 12 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of participants with treatment-related adverse events as assessed by CTCAE v4.0</measure>
    <time_frame>12 weeks</time_frame>
    <description>number of adverse events and serious adverse events associated with treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>percentage of patients who achieved particular response rate as follows none 0%; poor 1-25%; moderate 26-50%; good 51-75%; excellent &gt;75% in each arm assessed as a relative reduction in lesional skin area</measure>
    <time_frame>12 weeks</time_frame>
    <description>number of: poor 1-25%; moderate 26-50%; good 51-75%; excellent &gt;75% responders in each arm assessed as a relative reduction in lesional skin area (in sqare centimeters)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>percentage of patients who achieved particular response rate as follows none 0%; poor 1-25%; moderate 26-50%; good 51-75%; excellent &gt;75% in each arm assessed as a relative reduction in BSA scale</measure>
    <time_frame>12 weeks</time_frame>
    <description>number of: poor 1-25%; moderate 26-50%; good 51-75%; excellent &gt;75% responders in each arm assessed as a relative reduction in BSA scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>percentage of patients who achieved particular response rate as follows none 0%; poor 1-25%; moderate 26-50%; good 51-75%; excellent &gt;75% in each arm assessed as a relative reduction in VASI scale</measure>
    <time_frame>12 weeks</time_frame>
    <description>number of: poor 1-25%; moderate 26-50%; good 51-75%; excellent &gt;75% responders in each arm assessed as a relative reduction in VASI scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>comparison of simvastatin and atorvastatin efficacy between study participants</measure>
    <time_frame>12 weeks</time_frame>
    <description>comparison of BSA and VASI scale change between simvastatin and atorvastatin arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the association between disease duration and repigmentation rate in study arms</measure>
    <time_frame>12 weeks</time_frame>
    <description>the association between disease duration and repigmentation rate in study arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the association between estimated daily ointment use (grams per square centimeter skin) and repigmentation rate</measure>
    <time_frame>12 weeks</time_frame>
    <description>the association between estimated daily ointment use (grams per square centimeter skin) and repigmentation rate</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Non-segmental Vitiligo</condition>
  <arm_group>
    <arm_group_label>1% simvastatin-acid sodium salt ointment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>1% simvastatin-acid sodium salt ointment applied onto a predefined limb compared with placebo ointment applied onto an opposite limb</description>
  </arm_group>
  <arm_group>
    <arm_group_label>1% atorvastatin calcium salt ointment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>1% atorvastatin calcium salt ointment applied onto a predefined limb compared with placebo ointment applied onto an opposite limb</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle ointment</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo ointment applied onto limbs opposite to treated with active substances</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>1% simvastatin-acid sodium salt ointment</intervention_name>
    <description>1% simvastatin-acid sodium salt ointment applied onto a predefined limb</description>
    <arm_group_label>1% simvastatin-acid sodium salt ointment</arm_group_label>
    <arm_group_label>Vehicle ointment</arm_group_label>
    <other_name>simvastatin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>1% atorvastatin calcium salt ointment</intervention_name>
    <description>1% atorvastatin calcium salt ointment applied onto a predefined limb</description>
    <arm_group_label>1% atorvastatin calcium salt ointment</arm_group_label>
    <arm_group_label>Vehicle ointment</arm_group_label>
    <other_name>atorvastatin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. patients of Clinic of Dermatology, Sexually Transmitted Diseases and&#xD;
             Immunodermatology, Nicolaus Copernicus University, Collegium Medicum in Bydgoszcz&#xD;
&#xD;
          2. provision of an informed consent form prior to any study procedures&#xD;
&#xD;
          3. diagnosis of non-segmental acrofacial vitiligo with upper and lower limbs involvement&#xD;
&#xD;
          4. active vitiligo, defined as appearance of new areas of depigmentation or progression&#xD;
             of existing areas of depigmentation within 3 months preceding screening&#xD;
&#xD;
          5. male or non-pregnant female patients aged 18 to 80 years&#xD;
&#xD;
          6. confirmed valid health insurance&#xD;
&#xD;
        all inclusion criteria must be met&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. pregnancy or breast-feeding&#xD;
&#xD;
          2. diagnosis of segmental, mixed, unclassified or undefined vitiligo&#xD;
&#xD;
          3. hypersensitivity to simvastatin or atorvastatin&#xD;
&#xD;
          4. any statins use within 8 weeks preceding eligibility screening&#xD;
&#xD;
          5. systemic immunosuppressive/immunomodulating i.e. cyclosporine A, corticosteroids&#xD;
             within 4 weeks preceding eligibility screening or azathioprine, methotrexate,&#xD;
             mycophenolate mofetil, Janus kinase - JAK within 8 weeks preceding eligibility&#xD;
             screening&#xD;
&#xD;
          6. phototherapy due to vitiligo or any other medical conditions within the 4-week period&#xD;
             preceding eligibility screening&#xD;
&#xD;
          7. any topical or systemic additional vitiligo treatment (e.g. antioxidants, ginkgo&#xD;
             biloba, dermo-cosmetics) within 4 weeks preceding screening&#xD;
&#xD;
          8. surgical treatment of vitiligous lesions within past 4 weeks&#xD;
&#xD;
          9. hypersensitivity to statins&#xD;
&#xD;
         10. decompensated autoimmune or internal diseases&#xD;
&#xD;
         11. alcohol or drug abuse&#xD;
&#xD;
         12. skin malignancies (currently or history of skin malignancy within 5 years preceding&#xD;
             screening)&#xD;
&#xD;
         13. presence of skin characteristics that may interfere with study assessments&#xD;
&#xD;
         14. patients currently participating in any other clinical study&#xD;
&#xD;
         15. uncooperative patients&#xD;
&#xD;
        none of the above can be met&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rafal Czajkowski, Prof NCU</last_name>
    <role>Principal Investigator</role>
    <affiliation>Head of Chair and Clinic of Dermatology, Sexually Transmitted Diseases and Immunodermatology, Nicolaus Copernicus University in Torun, Ludwik Rydygier Medical College in Bydgoszcz</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinic of Dermatology, Sexually Transmitted Diseases and Immunodermatology, Nicolaus Copernicus University, Faculty of Medicine in Bydgoszcz</name>
      <address>
        <city>Bydgoszcz</city>
        <state>Cuiavian-Pomeranian</state>
        <zip>85094</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>August 5, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>September 21, 2020</last_update_submitted>
  <last_update_submitted_qc>September 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nicolaus Copernicus University</investigator_affiliation>
    <investigator_full_name>Rafal Czajkowski</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </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>Atorvastatin</mesh_term>
    <mesh_term>Simvastatin</mesh_term>
    <mesh_term>Calcium</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03247400
org study id: NCU 631
nct id: NCT03247400
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate the influence of simvastatin and atorvastatin on
      vitiligous lesions in patients with non-segmental vitiligo.
According to available data, statins act through several immunological pathways, potentially
      reversing undesirable phenomena underlying autoimmune vitiligo pathogenesis. A study has been
      designed as a single-center, randomized, double-blind, placebo-controlled pilot study with
      the enrollment of at least 20 active non-segmental vitiligo patients presenting with
      vitiligous lesions on both upper and lower limbs. Clinical effects of ointments containing 1%
      simvastatin-acid sodium salt or 1% atorvastatin calcium salt applied on a preselected limb
      will be assessed in comparison with vehicle ointment applied on the opposite limb. All study
      participants will undergo clinical evaluation using Body Surface Area (BSA) and Vitiligo Area
      Scoring Index (VASI) scales at baseline, week 4, week 8 and week 12 time points. Precise
      assessment of skin lesions will be performed using photographic documentation obtained during
      each study visit and processed with NIS-Elements software.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: evaluation of repigmentation of vitiligous lesions achieved after the administration of 1% simvastatin-acid sodium salt or 1% atorvastatin calcium salt ointments compared to vehicle ointments after a 12-week study period.
time frame: 12 weeks
description: change from baseline in repigmentation on BSA and VASI scale at 12 weeks
measure: number of participants with treatment-related adverse events as assessed by CTCAE v4.0
time frame: 12 weeks
description: number of adverse events and serious adverse events associated with treatment
measure: percentage of patients who achieved particular response rate as follows none 0%; poor 1-25%; moderate 26-50%; good 51-75%; excellent >75% in each arm assessed as a relative reduction in lesional skin area
time frame: 12 weeks
description: number of: poor 1-25%; moderate 26-50%; good 51-75%; excellent >75% responders in each arm assessed as a relative reduction in lesional skin area (in sqare centimeters)
measure: percentage of patients who achieved particular response rate as follows none 0%; poor 1-25%; moderate 26-50%; good 51-75%; excellent >75% in each arm assessed as a relative reduction in BSA scale
time frame: 12 weeks
description: number of: poor 1-25%; moderate 26-50%; good 51-75%; excellent >75% responders in each arm assessed as a relative reduction in BSA scale
measure: percentage of patients who achieved particular response rate as follows none 0%; poor 1-25%; moderate 26-50%; good 51-75%; excellent >75% in each arm assessed as a relative reduction in VASI scale
time frame: 12 weeks
description: number of: poor 1-25%; moderate 26-50%; good 51-75%; excellent >75% responders in each arm assessed as a relative reduction in VASI scale
measure: comparison of simvastatin and atorvastatin efficacy between study participants
time frame: 12 weeks
description: comparison of BSA and VASI scale change between simvastatin and atorvastatin arms
measure: the association between disease duration and repigmentation rate in study arms
time frame: 12 weeks
description: the association between disease duration and repigmentation rate in study arms
measure: the association between estimated daily ointment use (grams per square centimeter skin) and repigmentation rate
time frame: 12 weeks
description: the association between estimated daily ointment use (grams per square centimeter skin) and repigmentation rate
arm group label: 1% simvastatin-acid sodium salt ointment
arm group type: Active Comparator
description: 1% simvastatin-acid sodium salt ointment applied onto a predefined limb compared with placebo ointment applied onto an opposite limb
arm group label: 1% atorvastatin calcium salt ointment
arm group type: Active Comparator
description: 1% atorvastatin calcium salt ointment applied onto a predefined limb compared with placebo ointment applied onto an opposite limb
arm group label: Vehicle ointment
arm group type: Placebo Comparator
description: Placebo ointment applied onto limbs opposite to treated with active substances
intervention type: Drug
intervention name: 1% simvastatin-acid sodium salt ointment
description: 1% simvastatin-acid sodium salt ointment applied onto a predefined limb
arm group label: 1% simvastatin-acid sodium salt ointment
arm group label: Vehicle ointment
other name: simvastatin
intervention type: Drug
intervention name: 1% atorvastatin calcium salt ointment
description: 1% atorvastatin calcium salt ointment applied onto a predefined limb
arm group label: 1% atorvastatin calcium salt ointment
arm group label: Vehicle ointment
other name: atorvastatin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Rafal Czajkowski, Prof NCU
role: Principal Investigator
affiliation: Head of Chair and Clinic of Dermatology, Sexually Transmitted Diseases and Immunodermatology, Nicolaus Copernicus University in Torun, Ludwik Rydygier Medical College in Bydgoszcz
facility: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Nicolaus Copernicus University
investigator full name: Rafal Czajkowski
investigator title: Clinical Professor
mesh term: Vitiligo
mesh term: Atorvastatin
mesh term: Simvastatin
mesh term: Calcium
sharing ipd: No