<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/NCT04438135</url>
  </required_header>
  <id_info>
    <org_study_id>H-20009217</org_study_id>
    <nct_id>NCT04438135</nct_id>
  </id_info>
  <brief_title>Children With Aluminium Contact Allergy: Cutaneous Exposure Study</brief_title>
  <official_title>Children With Aluminium Contact Allergy: Cutaneous Exposure Study</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aluminium is used in many different cosmetic products, including make-up, deodorants and&#xD;
      sunscreen. The purpose of this study is to investigate whether these everyday skin products&#xD;
      with small amounts of aluminium can cause skin reactions in children diagnosed with contact&#xD;
      allergy to aluminium.&#xD;
&#xD;
      The study is conducted as a Repeated Open Application Test study (ROAT), a method originally&#xD;
      developed to clarify the clinical relevance of questionable and positive patch samples, by&#xD;
      imitating everyday use of a skin product.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is conducted as a Repeated Open Application Test study (ROAT), a method originally&#xD;
      developed to clarify the clinical relevance of questionable and positive patch samples, by&#xD;
      imitating everyday use of a skin product.&#xD;
&#xD;
      The skin products will consist of ordinary sunscreens with and without aluminium, with colour&#xD;
      code red and blue, respectively (masked for both investigator and participants). At the&#xD;
      beginning of the trial, the study participants will be given the two creams. On the lower&#xD;
      back of the children, two areas each 10 cm2 are marked with red and blue, respectively. In&#xD;
      each area, sunscreen corresponding to the generally recommended amounts must be applied twice&#xD;
      a day.&#xD;
&#xD;
      The children should be seen on day 0 for interviews and objective examination. They must then&#xD;
      be seen again on day 7 and day 14. On day 14 of the ROAT, a patch test is made to validate&#xD;
      the results of the ROAT study. The study is scheduled to last for a maximum of 21 days with&#xD;
      4-5 consultations per child. If there is a skin reaction in connection with the ROAT study&#xD;
      before the 14 days have elapsed, the study will end and a patch test will be performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 10, 2020</start_date>
  <completion_date type="Actual">April 7, 2022</completion_date>
  <primary_completion_date type="Actual">April 7, 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>
    <intervention_model_description>Repeated Open Application test</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>positive test</measure>
    <time_frame>two weeks</time_frame>
    <description>After two weeks of daily application, both test sites on all children will be evaluated and scored according to ROAT guidelines. The ROAT will be considered positive at a score of 5 points or more. Photographs will be taken of all reactions (positive and negative) for documentation.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Contact Dermatitis</condition>
  <condition>Contact Allergy</condition>
  <condition>Aluminum Allergy</condition>
  <arm_group>
    <arm_group_label>active test</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo test</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Repeated open application test</intervention_name>
    <description>parallel application of two different types of lotion with and without aluminium.</description>
    <arm_group_label>active test</arm_group_label>
    <arm_group_label>placebo test</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children with contact allergies to aluminium, demonstrated by patch tests at the Skin&#xD;
             and Allergy Department, Gentofte Hospital and thus registered in the Clinical Database&#xD;
             for Contact Allergy.&#xD;
&#xD;
          -  Activity (itching) of the granulom within the last six months&#xD;
&#xD;
          -  Written consent obtained from all custodians.&#xD;
&#xD;
          -  Self-assessed worsening of skin symptoms after contact with aluminium-containing&#xD;
             sunscreens.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Treatment with systemic steroid preparations within 1 week.&#xD;
&#xD;
          -  Treatment with topical steroid preparations at or near the test area within 1 week.&#xD;
&#xD;
          -  Treatment with systemic immune suppression.&#xD;
&#xD;
          -  Treatment with antibiotics within 1 week.&#xD;
&#xD;
          -  If the children become ill during the study, they should contact the project manager&#xD;
             who will clinically assess the child and evaluate whether the child can continue to&#xD;
             participate in the study or should be excluded due to the possibility of&#xD;
             misinterpretation of any rash.&#xD;
&#xD;
          -  Active eczema or other skin symptoms on the tested area&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeanne Duus Johansen, Prof.</last_name>
    <role>Study Director</role>
    <affiliation>National Allergy Research Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Allergy Research Centre</name>
      <address>
        <city>Hellerup</city>
        <zip>2900</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>June 2020</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>April 7, 2022</last_update_submitted>
  <last_update_submitted_qc>April 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>vaccination granuloma</keyword>
  <keyword>aluminium contact allergy</keyword>
  <keyword>children</keyword>
  <keyword>contact dermatitis</keyword>
  <keyword>repeated open application test</keyword>
  <keyword>patch test</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Dermatitis, Contact</mesh_term>
    <mesh_term>Dermatitis, Allergic Contact</mesh_term>
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_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/NCT04438135
org study id: H-20009217
nct id: NCT04438135
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Aluminium is used in many different cosmetic products, including make-up, deodorants and
      sunscreen. The purpose of this study is to investigate whether these everyday skin products
      with small amounts of aluminium can cause skin reactions in children diagnosed with contact
      allergy to aluminium.

      The study is conducted as a Repeated Open Application Test study (ROAT), a method originally
      developed to clarify the clinical relevance of questionable and positive patch samples, by
      imitating everyday use of a skin product.
The study is conducted as a Repeated Open Application Test study (ROAT), a method originally
      developed to clarify the clinical relevance of questionable and positive patch samples, by
      imitating everyday use of a skin product.

      The skin products will consist of ordinary sunscreens with and without aluminium, with colour
      code red and blue, respectively (masked for both investigator and participants). At the
      beginning of the trial, the study participants will be given the two creams. On the lower
      back of the children, two areas each 10 cm2 are marked with red and blue, respectively. In
      each area, sunscreen corresponding to the generally recommended amounts must be applied twice
      a day.

      The children should be seen on day 0 for interviews and objective examination. They must then
      be seen again on day 7 and day 14. On day 14 of the ROAT, a patch test is made to validate
      the results of the ROAT study. The study is scheduled to last for a maximum of 21 days with
      4-5 consultations per child. If there is a skin reaction in connection with the ROAT study
      before the 14 days have elapsed, the study will end and a patch test will be performed.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Repeated Open Application test
primary purpose: Other
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: positive test
time frame: two weeks
description: After two weeks of daily application, both test sites on all children will be evaluated and scored according to ROAT guidelines. The ROAT will be considered positive at a score of 5 points or more. Photographs will be taken of all reactions (positive and negative) for documentation.
arm group label: active test
arm group type: Active Comparator
arm group label: placebo test
arm group type: Placebo Comparator
intervention type: Other
intervention name: Repeated open application test
description: parallel application of two different types of lotion with and without aluminium.
arm group label: active test
arm group label: placebo test
criteria: 
gender: All
minimum age: 2 Years
maximum age: 10 Years
healthy volunteers: No
last name: Jeanne Duus Johansen, Prof.
role: Study Director
affiliation: National Allergy Research Centre
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Dermatitis
mesh term: Dermatitis, Contact
mesh term: Dermatitis, Allergic Contact
mesh term: Hypersensitivity
sharing ipd: No