<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/NCT04438330</url>
  </required_header>
  <id_info>
    <org_study_id>H-19080328</org_study_id>
    <nct_id>NCT04438330</nct_id>
  </id_info>
  <brief_title>The Immunological Profile of Nickel Dermatitis</brief_title>
  <official_title>The Immunological Profile of Nickel Dermatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Allergy Research Center, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Copenhagen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Allergy Research Center, Denmark</source>
  <oversight_info>
    <has_dmc>Yes</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>
      A dose-response study on the immune phenotype of allergic nickel dermatitis on a previously&#xD;
      exposed skin area.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Clinically controlled study comprising 15 people with known nickel allergy and 15 healthy&#xD;
      persons as control group. At the Department of Allergy and Dermatology, Gentofte Hospital,&#xD;
      test participants will be exposed to nickel sulfate in a patch test on their back, which will&#xD;
      create an eczema reaction in people with nickel allergy and induce skin resident T-cells. The&#xD;
      resident T-cells will enhance further exposure. The eczema is healed over 3-4 weeks, after&#xD;
      which the same areas are again exposed to nickel sulfate at different concentrations in a&#xD;
      patch test. Skin biopsies of the exposed areas are taken and the immune phenotype is analyzed&#xD;
      trough Nanostring RNA technologies of around 600 immunerelated genes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2021</start_date>
  <completion_date type="Actual">June 1, 2022</completion_date>
  <primary_completion_date type="Actual">June 1, 2022</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>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>mRNA Nanostring screening</measure>
    <time_frame>1 month</time_frame>
    <description>Screening of 600 immune-related genes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Protein verification</measure>
    <time_frame>2 month</time_frame>
    <description>verification of differentially regulated mRNA at a protein level.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Allergic response</measure>
    <time_frame>1 day</time_frame>
    <description>Clinical evaluation of allergic response to a dose-range</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Nickel; Eczema</condition>
  <condition>Nickel Sensitivity</condition>
  <condition>Allergy</condition>
  <condition>Inflammatory Response</condition>
  <arm_group>
    <arm_group_label>Nickel allergic individuals</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nickel sulfate hexahydrate in petrolatum. Exposed in a patch test dose-range with a max concentration of 5% nickel sulfate hexahydrate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-nickel allergic individuals</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nickel sulfate hexahydrate in petrolatum. Exposed in a patch test dose-range with a max concentration of 5% nickel sulfate hexahydrate</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nickel sulfate hexahydrate</intervention_name>
    <description>Patch test</description>
    <arm_group_label>Nickel allergic individuals</arm_group_label>
    <arm_group_label>non-nickel allergic individuals</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        inclusion criteria&#xD;
&#xD;
          -  Must be able to understand the written and oral participant information in Danish.&#xD;
&#xD;
          -  Previously proven nick allergy by patch testing within the last 5 years, for the&#xD;
             nickel allergic test participants.&#xD;
&#xD;
        exclusion criteria&#xD;
&#xD;
          -  Pregnancy and / or breastfeeding.&#xD;
&#xD;
          -  Systemic immunomodulatory treatments within the last 14 days.&#xD;
&#xD;
          -  Local treatments of selected skin areas, such as applying hormone cream within the&#xD;
             last two weeks or applying cream / lotion within 24 hours up to sample collection.&#xD;
&#xD;
          -  Allergy to local anesthesia.&#xD;
&#xD;
          -  Exposed to solar or sunlight on the back within 21 days.&#xD;
&#xD;
          -  History of inflammatory skin diseases, asthma, Diabetes Mellitus, hives or arthritis&#xD;
             (exclusion criteria only for participation in the healthy control group).&#xD;
&#xD;
          -  Participation in another scientific experiment within the last 4 weeks. risks,&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeanne D Johansen, Proff.</last_name>
    <role>Study Director</role>
    <affiliation>National Allergy Research Center, Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Allergy Research Center</name>
      <address>
        <city>Hellerup</city>
        <state>Danmark</state>
        <zip>2900</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>January 3, 2023</last_update_submitted>
  <last_update_submitted_qc>January 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Patch test</keyword>
  <keyword>metal allergy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nickel</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/NCT04438330
org study id: H-19080328
nct id: NCT04438330
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A dose-response study on the immune phenotype of allergic nickel dermatitis on a previously
      exposed skin area.
Clinically controlled study comprising 15 people with known nickel allergy and 15 healthy
      persons as control group. At the Department of Allergy and Dermatology, Gentofte Hospital,
      test participants will be exposed to nickel sulfate in a patch test on their back, which will
      create an eczema reaction in people with nickel allergy and induce skin resident T-cells. The
      resident T-cells will enhance further exposure. The eczema is healed over 3-4 weeks, after
      which the same areas are again exposed to nickel sulfate at different concentrations in a
      patch test. Skin biopsies of the exposed areas are taken and the immune phenotype is analyzed
      trough Nanostring RNA technologies of around 600 immunerelated genes.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: mRNA Nanostring screening
time frame: 1 month
description: Screening of 600 immune-related genes
measure: Protein verification
time frame: 2 month
description: verification of differentially regulated mRNA at a protein level.
measure: Allergic response
time frame: 1 day
description: Clinical evaluation of allergic response to a dose-range
arm group label: Nickel allergic individuals
arm group type: Experimental
description: Nickel sulfate hexahydrate in petrolatum. Exposed in a patch test dose-range with a max concentration of 5% nickel sulfate hexahydrate
arm group label: non-nickel allergic individuals
arm group type: Active Comparator
description: Nickel sulfate hexahydrate in petrolatum. Exposed in a patch test dose-range with a max concentration of 5% nickel sulfate hexahydrate
intervention type: Other
intervention name: Nickel sulfate hexahydrate
description: Patch test
arm group label: Nickel allergic individuals
arm group label: non-nickel allergic individuals
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jeanne D Johansen, Proff.
role: Study Director
affiliation: National Allergy Research Center, Denmark
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Dermatitis
mesh term: Nickel
sharing ipd: No