<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/NCT03024671</url>
  </required_header>
  <id_info>
    <org_study_id>KEK-BE 2016-01686</org_study_id>
    <nct_id>NCT03024671</nct_id>
  </id_info>
  <brief_title>Epicutaneous Testing of Cosmetics for Skin Compatibility</brief_title>
  <official_title>Epicutaneous Testing of Cosmetic Products to Determine Skin Compatibility</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Insel Gruppe AG, University Hospital Bern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mibelle AG</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Insel Gruppe AG, University Hospital Bern</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>
      The dermatological testing of cosmetic products which are new on the market, or existing&#xD;
      products with novel formulations is common and a useful procedure, yet necessary to alleviate&#xD;
      common irritants and contact allergic reactions. Cosmetic products contain a range of&#xD;
      substances that may be considered as potential irritants or contact allergens. In order to&#xD;
      estimate that risk, cosmetics are tested by applying patch tests.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The dermatological testing of cosmetic products which are new on the market, or existing&#xD;
      products with novel formulations is common and a useful procedure, yet necessary to alleviate&#xD;
      common irritants and contact allergic reactions. Cosmetic products contain a range of&#xD;
      substances that may be considered as potential irritants or contact allergens. In order to&#xD;
      estimate that risk, cosmetics are tested by applying patch tests, as with allergic reactions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 10, 2017</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with positive patch test reactions to cosmetics</measure>
    <time_frame>4 weeks</time_frame>
    <description>Inflammation of Skin at test patch location</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Dermatitis</condition>
  <arm_group>
    <arm_group_label>patch test</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with patch test of cosmetics</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patch test application</intervention_name>
    <description>test patch with cosmetic product will be applied to the back</description>
    <arm_group_label>patch test</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women older than 18 years old&#xD;
&#xD;
          -  Persons undergoing a diagnostic patch test for reason of a skin disease&#xD;
&#xD;
          -  Signed written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute skin inflammation and eczema on the back&#xD;
&#xD;
          -  Systemic corticosteroid and immunosuppressive therapy as well as UV exposure of the&#xD;
             back within the last 4 weeks&#xD;
&#xD;
          -  Topical corticosteroids used on the back within the last two weeks&#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>Dagmar Simon, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dept. of Dermatology, Inselspital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dagmar Simon, MD</last_name>
    <phone>+41 31 632 2278</phone>
    <email>dagmar.simon@insel.ch</email>
  </overall_contact>
  <location>
    <facility>
      <name>Inselspital Bern</name>
      <address>
        <city>Bern</city>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dagmar Simon, MD</last_name>
      <phone>+41 31 632 2278</phone>
      <email>dagmar.simon@insel.ch</email>
    </contact>
    <contact_backup>
      <last_name>Mark Wienand</last_name>
      <email>studynurse.derma@insel.ch</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>February 20, 2023</last_update_submitted>
  <last_update_submitted_qc>February 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 22, 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</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>single centered study</ipd_description>
  </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/NCT03024671
org study id: KEK-BE 2016-01686
nct id: NCT03024671
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The dermatological testing of cosmetic products which are new on the market, or existing
      products with novel formulations is common and a useful procedure, yet necessary to alleviate
      common irritants and contact allergic reactions. Cosmetic products contain a range of
      substances that may be considered as potential irritants or contact allergens. In order to
      estimate that risk, cosmetics are tested by applying patch tests.
The dermatological testing of cosmetic products which are new on the market, or existing
      products with novel formulations is common and a useful procedure, yet necessary to alleviate
      common irritants and contact allergic reactions. Cosmetic products contain a range of
      substances that may be considered as potential irritants or contact allergens. In order to
      estimate that risk, cosmetics are tested by applying patch tests, as with allergic reactions.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Number of patients with positive patch test reactions to cosmetics
time frame: 4 weeks
description: Inflammation of Skin at test patch location
arm group label: patch test
arm group type: Experimental
description: Patients with patch test of cosmetics
intervention type: Other
intervention name: Patch test application
description: test patch with cosmetic product will be applied to the back
arm group label: patch test
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dagmar Simon, MD
role: Principal Investigator
affiliation: Dept. of Dermatology, Inselspital
last name: Dagmar Simon, MD
phone: +41 31 632 2278
email: dagmar.simon@insel.ch
facility: 
status: Recruiting
contact: 
contact backup: 
country: Switzerland
responsible party type: Sponsor
mesh term: Dermatitis
sharing ipd: No
ipd description: single centered study