<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/NCT03015103</url>
  </required_header>
  <id_info>
    <org_study_id>Kley Hertz 006</org_study_id>
    <nct_id>NCT03015103</nct_id>
  </id_info>
  <brief_title>Safety Dermatological Assessment of Topical Use Product Through Dressings Predictive Studies for Evaluation of Photoirritation and Dermal Photosensitivity</brief_title>
  <acronym>SAF DER ASSESS</acronym>
  <official_title>Safety Dermatological Assessment of Topical Use Product Through Dressings Predictive Studies for Evaluation of Photoirritation and Dermal Photosensitivity</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>
      The purpose of this study is to prove the product tested does not cause photoirritation or&#xD;
      photosensitization reactions when exposed to sun light.&#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>
  <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>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Photoirritation as measured through the use of dressings containing tested product and placebo</measure>
    <time_frame>5 days</time_frame>
    <description>The photoirritation will be measured with the use of four dressings that will be applied in the volunteer (3 dresssings containing different placebos and 1 containing the product). After some hours, the region is evaluated and radiated with UVA. That procedure occurs during the period of five days.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Photosensitization as measured through the use of dressings containing tested product and placebo</measure>
    <time_frame>32 days</time_frame>
    <description>The photosensitization will be measured with the use of four dressings that will be applied in the volunteer (3 dresssings containing different placebos and 1 containing the product). After some hours, the region is evaluated and radiated with UVA. That procedure occurs during the period of 32 days.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">28</enrollment>
  <condition>Skin Irritability</condition>
  <condition>Skin Sensitisation</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This study is designed as a single group assignment, because the 4 dressings (3 placebos and 1 containing the product) will be applied in all volunteers. This means that the region in which the tested product will be applied will be compared with the other placebo regions in the same volunteer.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intimate Lubrificant Gel</intervention_name>
    <description>All the volunteers will receive the application of four dressings (3 placebos and 1 containing the tested product). After a certain period of time, photoirritation and photosensitization will be measured through the evaluation of tested region.</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18 to 70 years old;&#xD;
&#xD;
          -  Skin types: I (light caucasian) or III (light brown);&#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;
             fixed 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 from 30 days up to three months prior&#xD;
             to selection;&#xD;
&#xD;
          -  Diseases that cause immune suppression;&#xD;
&#xD;
          -  Use of photosensitizing drugs;&#xD;
&#xD;
          -  History or photodermatoses activities;&#xD;
&#xD;
          -  Personal or family history of photoinduced skin cancer;&#xD;
&#xD;
          -  Presence of precursor lesions of skin cancer, such as melanocytic nevi and actinic&#xD;
             keratoses;&#xD;
&#xD;
          -  Intense sun exposure in the experiment area Use of new drugs and/or cosmetics during&#xD;
             the experiment;&#xD;
&#xD;
          -  Previous participation in a study with the same product under test;&#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>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>January 5, 2017</last_update_submitted>
  <last_update_submitted_qc>January 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 9, 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/NCT03015103
org study id: Kley Hertz 006
nct id: NCT03015103
lead sponsor: 
The purpose of this study is to prove the product tested does not cause photoirritation or
      photosensitization reactions when exposed to sun light.
allocation: N/A
intervention model: Single Group Assignment
masking: Single (Participant)
measure: Photoirritation as measured through the use of dressings containing tested product and placebo
time frame: 5 days
description: The photoirritation will be measured with the use of four dressings that will be applied in the volunteer (3 dresssings containing different placebos and 1 containing the product). After some hours, the region is evaluated and radiated with UVA. That procedure occurs during the period of five days.
measure: Photosensitization as measured through the use of dressings containing tested product and placebo
time frame: 32 days
description: The photosensitization will be measured with the use of four dressings that will be applied in the volunteer (3 dresssings containing different placebos and 1 containing the product). After some hours, the region is evaluated and radiated with UVA. That procedure occurs during the period of 32 days.
arm group label: Experimental group
arm group type: Experimental
description: This study is designed as a single group assignment, because the 4 dressings (3 placebos and 1 containing the product) will be applied in all volunteers. This means that the region in which the tested product will be applied will be compared with the other placebo regions in the same volunteer.
intervention type: Device
intervention name: Intimate Lubrificant Gel
description: All the volunteers will receive the application of four dressings (3 placebos and 1 containing the tested product). After a certain period of time, photoirritation and photosensitization will be measured through the evaluation of tested region.
arm group label: Experimental group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor