<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/NCT02968446</url>
  </required_header>
  <id_info>
    <org_study_id>09-16-36C</org_study_id>
    <secondary_id>U01AR064144-01</secondary_id>
    <secondary_id>CASE3416</secondary_id>
    <nct_id>NCT02968446</nct_id>
  </id_info>
  <brief_title>Effect of Vitamin D After Application With Valchlor</brief_title>
  <official_title>The Effect of Oral Vitamin D (Cholecalciferol) Supplementation After Topical Application With Valchlor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospitals Cleveland Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospitals Cleveland Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</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>
      The purpose of this research study is to evaluate the effects of an oral Vitamin D on the&#xD;
      body's immune system.&#xD;
&#xD;
      An interest has been growing because studies have shown that Vitamin D may reduce&#xD;
      inflammation and harmful effects in the body, however, the best dose for Vitamin D is still&#xD;
      unknown.&#xD;
&#xD;
      Inflammation is the body's physical response to infection, injury, or long term disease.&#xD;
      Pain, redness, heat, and sometimes loss of function are all signs of inflammation in the&#xD;
      body. This study will look at product use, testing skin irritation in healthy volunteers and&#xD;
      seeing how Vitamin D may help stop or reduce inflammation and skin irritation, which could&#xD;
      one day help doctors prescribe Vitamin D to patients with long term disease to relieve their&#xD;
      symptoms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary Endpoint To determine the effect of a topical application of Valchlor on human&#xD;
      subjects at the clinically approved dose.&#xD;
&#xD;
      Secondary Endpoint To establish the efficacy of cholecalciferol (vitamin D3) in reducing skin&#xD;
      irritation 48 hours after topical application of Valchlor.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 17, 2016</start_date>
  <completion_date type="Actual">October 1, 2018</completion_date>
  <primary_completion_date type="Actual">October 1, 2018</primary_completion_date>
  <phase>Early Phase 1</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>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in skin erythema</measure>
    <time_frame>Up to 1 week after mechloroethamine exposure</time_frame>
    <description>Skin erythema (redness) will be quantified using a CR300 chromameter. The difference in erythema between exposed and non-exposed skin will be calculated after valchlor exposure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in skin thickness</measure>
    <time_frame>Up to 1 week after mechloroethamine exposure</time_frame>
    <description>Skin thickness, an acute measure of edema, was quantified using a Mitutoyo 9mm dial caliper. Thickness measurements will be repeated in triplicate and the mean was used for all calculations. The difference in thickness between exposed and non-exposed skin will be calculated after valchlor exposure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in TNF-alpha expression</measure>
    <time_frame>Up to 120 hours after mechloroethamine exposure</time_frame>
    <description>A 6 mm punch biopsy specimen will be obtained from the valchlor exposure site 48hr after exposure. RNA will be extracted from fresh frozen punch biopsies using the RNeasy Lipid Mini Kit, and tissue mRNA expression of TNF-α will be quantified</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in iNOS expression</measure>
    <time_frame>Up to 120 hours after mechloroethamine exposure</time_frame>
    <description>A 6 mm punch biopsy specimen will be obtained from the valchlor exposure site 48hr after exposure. RNA will be extracted from fresh frozen punch biopsies using the RNeasy Lipid Mini Kit, and tissue mRNA expression of iNOS will be quantified</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Skin Irritation</condition>
  <arm_group>
    <arm_group_label>Group 1: 4 placebo - 0 Vitamin D with Valchlor</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will be given 4 placebo capsules and 0 cholecalciferol (Vitamin D) capsules after being treated with Valchlor.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2: 0 placebo - 4 Vitamin D with mechloroethamine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be given 0 placebo capsules and 4 cholecalciferol capsules to total 200,000 IU of cholecalciferol (Vitamin D) after being treated with Valchlor.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>4 placebo</intervention_name>
    <description>subjects will take orally 4 pills without any active ingredients which are of the same size, shape and color as the study pills</description>
    <arm_group_label>Group 1: 4 placebo - 0 Vitamin D with Valchlor</arm_group_label>
    <other_name>placebo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>4 Vitamin D</intervention_name>
    <description>subjects will take orally four pills for a single dose of 200,000 IU of Vitamin D (cholecalciferol)</description>
    <arm_group_label>Group 2: 0 placebo - 4 Vitamin D with mechloroethamine</arm_group_label>
    <other_name>cholecalciferol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Valchlor</intervention_name>
    <description>Twice during the study, subjects will be given 0.016% Valchlor at 3 locations (for a total of 6 locations) in the inner arm using Finn ChambersTM</description>
    <arm_group_label>Group 1: 4 placebo - 0 Vitamin D with Valchlor</arm_group_label>
    <arm_group_label>Group 2: 0 placebo - 4 Vitamin D with mechloroethamine</arm_group_label>
    <other_name>Mechlorethamine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must be in general good health&#xD;
&#xD;
          -  Fitzpatrick Skin Type I-VI&#xD;
&#xD;
          -  Able to list all current medications and medical conditions&#xD;
&#xD;
          -  Capable of giving informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who are pregnant, nursing, or who may become pregnant in the next 3 months&#xD;
&#xD;
          -  Participants taking illegal drugs&#xD;
&#xD;
          -  Currently taking ketoconazole, colestipol, cholestyramine, phenobarbitol, phenytoin,&#xD;
             or mineral oil&#xD;
&#xD;
          -  Currently consuming 800IU or more of vitamin D a day&#xD;
&#xD;
          -  Subjects whose BMI are &gt; 40&#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>Kurt Lu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospitals</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>December 6, 2021</last_update_submitted>
  <last_update_submitted_qc>December 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospitals Cleveland Medical Center</investigator_affiliation>
    <investigator_full_name>Kurt Lu</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Valchlor</keyword>
  <keyword>Vitamin D</keyword>
  <keyword>Healthy Volunteer</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</mesh_term>
    <mesh_term>Cholecalciferol</mesh_term>
    <mesh_term>Mechlorethamine</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/NCT02968446
org study id: 09-16-36C
secondary id: U01AR064144-01
secondary id: CASE3416
nct id: NCT02968446
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The purpose of this research study is to evaluate the effects of an oral Vitamin D on the
      body's immune system.

      An interest has been growing because studies have shown that Vitamin D may reduce
      inflammation and harmful effects in the body, however, the best dose for Vitamin D is still
      unknown.

      Inflammation is the body's physical response to infection, injury, or long term disease.
      Pain, redness, heat, and sometimes loss of function are all signs of inflammation in the
      body. This study will look at product use, testing skin irritation in healthy volunteers and
      seeing how Vitamin D may help stop or reduce inflammation and skin irritation, which could
      one day help doctors prescribe Vitamin D to patients with long term disease to relieve their
      symptoms.
Primary Endpoint To determine the effect of a topical application of Valchlor on human
      subjects at the clinically approved dose.

      Secondary Endpoint To establish the efficacy of cholecalciferol (vitamin D3) in reducing skin
      irritation 48 hours after topical application of Valchlor.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: Change in skin erythema
time frame: Up to 1 week after mechloroethamine exposure
description: Skin erythema (redness) will be quantified using a CR300 chromameter. The difference in erythema between exposed and non-exposed skin will be calculated after valchlor exposure
measure: Change in skin thickness
time frame: Up to 1 week after mechloroethamine exposure
description: Skin thickness, an acute measure of edema, was quantified using a Mitutoyo 9mm dial caliper. Thickness measurements will be repeated in triplicate and the mean was used for all calculations. The difference in thickness between exposed and non-exposed skin will be calculated after valchlor exposure.
measure: Change in TNF-alpha expression
time frame: Up to 120 hours after mechloroethamine exposure
description: A 6 mm punch biopsy specimen will be obtained from the valchlor exposure site 48hr after exposure. RNA will be extracted from fresh frozen punch biopsies using the RNeasy Lipid Mini Kit, and tissue mRNA expression of TNF-α will be quantified
measure: Change in iNOS expression
time frame: Up to 120 hours after mechloroethamine exposure
description: A 6 mm punch biopsy specimen will be obtained from the valchlor exposure site 48hr after exposure. RNA will be extracted from fresh frozen punch biopsies using the RNeasy Lipid Mini Kit, and tissue mRNA expression of iNOS will be quantified
arm group label: Group 1: 4 placebo - 0 Vitamin D with Valchlor
arm group type: Placebo Comparator
description: Participants will be given 4 placebo capsules and 0 cholecalciferol (Vitamin D) capsules after being treated with Valchlor.
arm group label: Group 2: 0 placebo - 4 Vitamin D with mechloroethamine
arm group type: Experimental
description: Participants will be given 0 placebo capsules and 4 cholecalciferol capsules to total 200,000 IU of cholecalciferol (Vitamin D) after being treated with Valchlor.
intervention type: Dietary Supplement
intervention name: 4 placebo
description: subjects will take orally 4 pills without any active ingredients which are of the same size, shape and color as the study pills
arm group label: Group 1: 4 placebo - 0 Vitamin D with Valchlor
other name: placebo
intervention type: Dietary Supplement
intervention name: 4 Vitamin D
description: subjects will take orally four pills for a single dose of 200,000 IU of Vitamin D (cholecalciferol)
arm group label: Group 2: 0 placebo - 4 Vitamin D with mechloroethamine
other name: cholecalciferol
intervention type: Drug
intervention name: Valchlor
description: Twice during the study, subjects will be given 0.016% Valchlor at 3 locations (for a total of 6 locations) in the inner arm using Finn ChambersTM
arm group label: Group 1: 4 placebo - 0 Vitamin D with Valchlor
arm group label: Group 2: 0 placebo - 4 Vitamin D with mechloroethamine
other name: Mechlorethamine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kurt Lu, MD
role: Principal Investigator
affiliation: Northwestern University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University Hospitals Cleveland Medical Center
investigator full name: Kurt Lu
investigator title: Assistant Professor
mesh term: Vitamin D
mesh term: Cholecalciferol
mesh term: Mechlorethamine