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/NCT06042309</url>
    </required_header>
    <id_info>
      <org_study_id>H-22058515</org_study_id>
      <nct_id>NCT06042309</nct_id>
    </id_info>
    <brief_title>Contact Allergy to Rubber Accelerators - a Clinical Study</brief_title>
    <official_title>Improving the Diagnosis and Prevention of Contact Allergy to Rubber Accelerators</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Allergy Research Center, Denmark</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Allergy Research Center, Denmark</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>
        This study will investigate what concentrations of the most common thiurams and carbamates&#xD;
        that elicit allergic contact dermatitis under patch test and what concentrations of the&#xD;
        rubber accelerators that elicit allergic contact dermatitis by repeated exposures under&#xD;
        simulated use conditions. Further, it will investigate whether a damaged skin barrier as&#xD;
        caused by wet work increase the severity of the allergic contact dermatitis.&#xD;
  &#xD;
        The participants will be assigned to either the SLS (sodium lauryl sulfate)-group or non&#xD;
        SLS-group. For the participants of the SLS-group, one volar forearm will be randomized to be&#xD;
        pre-irritated with a soap i.e. detergent: sodium lauryl sulfate (SLS) for 24 hours to&#xD;
        simulate wet work. The participants of the non SLS-group will not be pre-irritated with SLS.&#xD;
  &#xD;
        Following this, the participants' volar forearms will be exposed to thiurams or carbamates&#xD;
        and a control solution every night for 7 nights to simulate the repeated exposure to rubber&#xD;
        gloves with accelerators. The skin reactions will be read cf. current international&#xD;
        guidelines and further quantified using laser Doppler flowmetry.&#xD;
  &#xD;
        During the study, all participants will be patch tested on the upper back with rubber&#xD;
        accelerators to investigate their current degree of sensitization and the dose-response&#xD;
        relationships.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 1, 2024</start_date>
    <completion_date type="Anticipated">March 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2024</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>
      <intervention_model_description>The participants are assigned to either the SLS-group or NON-SLS-group.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <masking_description>The forearm randomized to SLS and the order in which the different concentrations of thiurams and carbamates and the control solution are applied to the skin, will be blinded for the reader of the skin reactions and the latter also for the participant.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Reading of skin reactions</measure>
      <time_frame>Day 0, Day 1 (only participants' arms in the SLS-group), Day 2 and Day 3 or Day 4, and Day 7, and Day 8. Further, eventually, if any reactions occur up to Day 16.</time_frame>
      <description>Development of dermatitis by reading of skin reactions based on international dermatitis scoring guidelines.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Skin blood flow</measure>
      <time_frame>Day 0, Day 1 (only participants' arms in the SLS-group), Day 2 and Day 3 or Day 4, and Day 7, and Day 8. Further, eventually, if any reactions occur up to Day 16.</time_frame>
      <description>Changes in blood flow on the arms using laser doppler flowmetry</description>
    </primary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Contact Allergy</condition>
    <arm_group>
      <arm_group_label>NON-SLS, Allergic participants</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants allergic to thiurams or carbamates assigned to the NON-SLS group.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>NON-SLS, Control participants</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants not allergic to thiurams or carbamates assigned to the NON-SLS group.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>SLS, Allergic participants</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants allergic to thiurams or carbamates assigned to the SLS group.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>SLS, Control participants</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants not allergic to thiurams or carbamates assigned to the SLS group.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Rubber accelerators and control chamber/solution for NON-SLS group</intervention_name>
      <description>Repeated exposure to rubber accelerators and control chamber/solution on arms. Three different concentrations of rubber accelerators and one control chamber/solution will be applied on the arms.</description>
      <arm_group_label>NON-SLS, Allergic participants</arm_group_label>
      <arm_group_label>NON-SLS, Control participants</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>SLS</intervention_name>
      <description>Exposure to SLS on a randomized arm</description>
      <arm_group_label>SLS, Allergic participants</arm_group_label>
      <arm_group_label>SLS, Control participants</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Rubber accelerators and control chamber/solution for SLS group</intervention_name>
      <description>Repeated exposure to rubber accelerators and control chamber/solution on arms. Two different concentrations of rubber accelerators and one control chamber/solution will be applied on both arms.</description>
      <arm_group_label>SLS, Allergic participants</arm_group_label>
      <arm_group_label>SLS, Control participants</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Patch test on back</intervention_name>
      <description>Patch test on the back with thiurams or carbamates in different concentrations and a control chamber/solution</description>
      <arm_group_label>NON-SLS, Allergic participants</arm_group_label>
      <arm_group_label>NON-SLS, Control participants</arm_group_label>
      <arm_group_label>SLS, Allergic participants</arm_group_label>
      <arm_group_label>SLS, Control participants</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Allergic participants&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adults ≥18 years old&#xD;
  &#xD;
            -  Sensitized to thiurams, carbamates or both.&#xD;
  &#xD;
            -  Received written and oral information about the study.&#xD;
  &#xD;
            -  Signed written consent form&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Dermatitis on back or arms&#xD;
  &#xD;
            -  Tattoos or significant scar tissue on exposure areas&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Breast feeding&#xD;
  &#xD;
            -  Recently given birth&#xD;
  &#xD;
            -  Treatment with systemic immunomodulators within the last 4 weeks&#xD;
  &#xD;
            -  Treatment with local immunomodulators on arms or back within the last 4 weeks&#xD;
  &#xD;
            -  Excessive ultraviolet light on arms or back within the last 4 weeks&#xD;
  &#xD;
          Healthy Controls:&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            -  adults ≥18 years old&#xD;
  &#xD;
            -  Received written and oral information about the study.&#xD;
  &#xD;
            -  Signed written consent form&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Sensitized to thiurams, carbamates or both.&#xD;
  &#xD;
            -  Occupational or domestical use of rubber gloves.&#xD;
  &#xD;
            -  History of atopic dermatitis or contact dermatitis&#xD;
  &#xD;
            -  Dermatitis on back or arms&#xD;
  &#xD;
            -  Tattoos or significant scar tissue on exposure areas&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Breast feeding&#xD;
  &#xD;
            -  Recently given birth&#xD;
  &#xD;
            -  Treatment with systemic immunomodulators within the last 4 weeks&#xD;
  &#xD;
            -  Treatment with local immunomodulators on arms or back within the last 4 weeks&#xD;
  &#xD;
            -  Excessive ultraviolet light on arms or back within the last 4 weeks&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Christoffer Kursawe Larsen, MD</last_name>
      <phone>+4538673940</phone>
      <email>christoffer.kursawe.larsen.01@regionh.dk</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 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 18, 2023</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>Dermatitis, Allergic Contact</mesh_term>
      <mesh_term>Hypersensitivity</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pharmaceutical Solutions</mesh_term>
    </intervention_browse>
    <!-- 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/NCT06042309
  org study id: H-22058515
  nct id: NCT06042309
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study will investigate what concentrations of the most common thiurams and carbamates
        that elicit allergic contact dermatitis under patch test and what concentrations of the
        rubber accelerators that elicit allergic contact dermatitis by repeated exposures under
        simulated use conditions. Further, it will investigate whether a damaged skin barrier as
        caused by wet work increase the severity of the allergic contact dermatitis.
  
        The participants will be assigned to either the SLS (sodium lauryl sulfate)-group or non
        SLS-group. For the participants of the SLS-group, one volar forearm will be randomized to be
        pre-irritated with a soap i.e. detergent: sodium lauryl sulfate (SLS) for 24 hours to
        simulate wet work. The participants of the non SLS-group will not be pre-irritated with SLS.
  
        Following this, the participants' volar forearms will be exposed to thiurams or carbamates
        and a control solution every night for 7 nights to simulate the repeated exposure to rubber
        gloves with accelerators. The skin reactions will be read cf. current international
        guidelines and further quantified using laser Doppler flowmetry.
  
        During the study, all participants will be patch tested on the upper back with rubber
        accelerators to investigate their current degree of sensitization and the dose-response
        relationships.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: The participants are assigned to either the SLS-group or NON-SLS-group.
  primary purpose: Prevention
  masking: Double (Participant, Outcomes Assessor)
  masking description: The forearm randomized to SLS and the order in which the different concentrations of thiurams and carbamates and the control solution are applied to the skin, will be blinded for the reader of the skin reactions and the latter also for the participant.
  measure: Reading of skin reactions
  time frame: Day 0, Day 1 (only participants' arms in the SLS-group), Day 2 and Day 3 or Day 4, and Day 7, and Day 8. Further, eventually, if any reactions occur up to Day 16.
  description: Development of dermatitis by reading of skin reactions based on international dermatitis scoring guidelines.
  measure: Skin blood flow
  time frame: Day 0, Day 1 (only participants' arms in the SLS-group), Day 2 and Day 3 or Day 4, and Day 7, and Day 8. Further, eventually, if any reactions occur up to Day 16.
  description: Changes in blood flow on the arms using laser doppler flowmetry
  arm group label: NON-SLS, Allergic participants
  arm group type: Experimental
  description: Participants allergic to thiurams or carbamates assigned to the NON-SLS group.
  arm group label: NON-SLS, Control participants
  arm group type: Experimental
  description: Participants not allergic to thiurams or carbamates assigned to the NON-SLS group.
  arm group label: SLS, Allergic participants
  arm group type: Experimental
  description: Participants allergic to thiurams or carbamates assigned to the SLS group.
  arm group label: SLS, Control participants
  arm group type: Experimental
  description: Participants not allergic to thiurams or carbamates assigned to the SLS group.
  intervention type: Other
  intervention name: Rubber accelerators and control chamber/solution for NON-SLS group
  description: Repeated exposure to rubber accelerators and control chamber/solution on arms. Three different concentrations of rubber accelerators and one control chamber/solution will be applied on the arms.
  arm group label: NON-SLS, Allergic participants
  arm group label: NON-SLS, Control participants
  intervention type: Other
  intervention name: SLS
  description: Exposure to SLS on a randomized arm
  arm group label: SLS, Allergic participants
  arm group label: SLS, Control participants
  intervention type: Other
  intervention name: Rubber accelerators and control chamber/solution for SLS group
  description: Repeated exposure to rubber accelerators and control chamber/solution on arms. Two different concentrations of rubber accelerators and one control chamber/solution will be applied on both arms.
  arm group label: SLS, Allergic participants
  arm group label: SLS, Control participants
  intervention type: Other
  intervention name: Patch test on back
  description: Patch test on the back with thiurams or carbamates in different concentrations and a control chamber/solution
  arm group label: NON-SLS, Allergic participants
  arm group label: NON-SLS, Control participants
  arm group label: SLS, Allergic participants
  arm group label: SLS, Control participants
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Christoffer Kursawe Larsen, MD
  phone: +4538673940
  email: christoffer.kursawe.larsen.01@regionh.dk
  responsible party type: Sponsor
  mesh term: Dermatitis, Allergic Contact
  mesh term: Hypersensitivity
  mesh term: Pharmaceutical Solutions