<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/NCT03007498</url>
  </required_header>
  <id_info>
    <org_study_id>Kley Hertz 005</org_study_id>
    <nct_id>NCT03007498</nct_id>
  </id_info>
  <brief_title>Dermatological Evaluation of Topical Compatibility, Primary Skin Irritability, Accumulated Skin Irritability, and Dermal Sensitisation</brief_title>
  <acronym>DERM EV TOPIC</acronym>
  <official_title>Dermatological Evaluation of Topical Compatibility, Primary Skin Irritability, Accumulated Skin Irritability, and Dermal Sensitisation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kley Hertz S/A</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kley Hertz S/A</source>
  <brief_summary>
    <textblock>
      Check the safety under normal conditions of use through the verification of emergence signs&#xD;
      of irritability and sensitisation of the genital mucosa.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <primary_completion_date type="Anticipated">February 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of adverse effects in maximized conditions</measure>
    <time_frame>60 days</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">55</enrollment>
  <condition>Skin Irritability</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with age from 18 to 70 years old, with skin color varying between clear caucasian&#xD;
        to dark.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18 to 70 years old;&#xD;
&#xD;
          -  Skin types: I (light caucasian), II (caucasian), III (light dark) and IV (dark)&#xD;
&#xD;
          -  intact skin where the product will be applied&#xD;
&#xD;
          -  Agreement to comply with the test procedures and attend the clinic in the days and&#xD;
             ixed times for medical assessments and application and reading of dressings&#xD;
&#xD;
          -  Signature of informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy and lactation&#xD;
&#xD;
          -  Use of anti-inflammatory and immunosuppressive drugs from 30 days up to three months&#xD;
             prior to selection;&#xD;
&#xD;
          -  Diseases that cause immune suppression;&#xD;
&#xD;
          -  Personal history of atopy;&#xD;
&#xD;
          -  History of sensitisation and irritability to topical products;&#xD;
&#xD;
          -  Active cutaneous pathologies (local and / or scattered) that may interfere in the&#xD;
             study results;&#xD;
&#xD;
          -  Use of new drugs and/or cosmetics during the experiment;&#xD;
&#xD;
          -  Skin reactivity;&#xD;
&#xD;
          -  Previous participation in a study with the same product under test;&#xD;
&#xD;
          -  Volunteers who have congenital or acquired known immunodeficiency;&#xD;
&#xD;
          -  Relevant medical history or current evidence of alcohol or other drugs abuse;&#xD;
&#xD;
          -  Known historical or suspected intolerance to any ingredient of the product under study&#xD;
             (product under test or comparator);&#xD;
&#xD;
          -  Sponsor's employees involved in the study, or close family member of an employee&#xD;
             involved in the study;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>December 29, 2016</last_update_submitted>
  <last_update_submitted_qc>December 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03007498
org study id: Kley Hertz 005
nct id: NCT03007498
lead sponsor: 
Check the safety under normal conditions of use through the verification of emergence signs
      of irritability and sensitisation of the genital mucosa.
time perspective: Prospective
measure: Evaluation of adverse effects in maximized conditions
time frame: 60 days
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor