<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/NCT03012347</url>
  </required_header>
  <id_info>
    <org_study_id>19208</org_study_id>
    <nct_id>NCT03012347</nct_id>
  </id_info>
  <brief_title>Evaluation of a Gel Sunscreen in Controlled Use Conditions (208/2016)</brief_title>
  <official_title>Evaluation of a Gel Sunscreen in Controlled Use Conditions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bayer</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>
      To explore and quantify potential issues with application of a gel sunscreen in Outdoor Use&#xD;
      testing, in a controlled indoor environment&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 5, 2017</start_date>
  <completion_date type="Actual">January 19, 2017</completion_date>
  <primary_completion_date type="Actual">January 19, 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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feeling any discomfort after applying the product assessed by questionnaire</measure>
    <time_frame>15 minutes after each application</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Sunscreening Agents</condition>
  <arm_group>
    <arm_group_label>Sunscreen Users</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will participate in a 2-Day study involving three applications of a single test article each day. The first application will be followed by an exposure of 30 minutes in a hot room.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BAY987517</intervention_name>
    <description>Subjects will be instructed to apply the test article in a split-body and face configuration, to the assigned side of the body (face, arms, torso, and legs), as they normally would before going outdoors for a run, walk or other sport related activity. (Formulation: RB# Y73-161)</description>
    <arm_group_label>Sunscreen Users</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BullFrog Gel Sunscreen Land Sport SPF-50</intervention_name>
    <description>Subjects will be instructed to apply the test article in a split-body and face configuration, to the assigned side of the body (face, arms, torso, and legs), as they normally would before going outdoors for a run, walk or other sport related activity.</description>
    <arm_group_label>Sunscreen Users</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects may be male or female.&#xD;
&#xD;
          -  Subjects must be adults between 18 and 45 years of age.&#xD;
&#xD;
          -  Subjects must have and have had a consistently active lifestyle for at least the&#xD;
             previous few years (exercise&#xD;
&#xD;
          -  outdoors and in direct sun exposure at least 2 times per week for at least 30&#xD;
             minutes-acceptable activities include tennis, running, jogging, walking, golf, etc.),&#xD;
             i.e., outdoor activity should not be a new behavior.&#xD;
&#xD;
          -  Subjects must have used a sunscreen with SPF 50 or higher within the previous 9&#xD;
             months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who have received or used an Investigational New Drug within the last 30&#xD;
             days.&#xD;
&#xD;
          -  Subjects who have been active participants in another clinical or subjective product&#xD;
             performance study within the last 30 days.&#xD;
&#xD;
          -  Subjects who have a known allergy or sensitivity to sunscreen ingredients or test&#xD;
             materials.&#xD;
&#xD;
          -  Subjects with respiratory allergies or asthma.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>December 6, 2017</last_update_submitted>
  <last_update_submitted_qc>December 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sunscreening Agents</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03012347
org study id: 19208
nct id: NCT03012347
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To explore and quantify potential issues with application of a gel sunscreen in Outdoor Use
      testing, in a controlled indoor environment
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Feeling any discomfort after applying the product assessed by questionnaire
time frame: 15 minutes after each application
arm group label: Sunscreen Users
arm group type: Experimental
description: Subjects will participate in a 2-Day study involving three applications of a single test article each day. The first application will be followed by an exposure of 30 minutes in a hot room.
intervention type: Drug
intervention name: BAY987517
description: Subjects will be instructed to apply the test article in a split-body and face configuration, to the assigned side of the body (face, arms, torso, and legs), as they normally would before going outdoors for a run, walk or other sport related activity. (Formulation: RB# Y73-161)
arm group label: Sunscreen Users
intervention type: Drug
intervention name: BullFrog Gel Sunscreen Land Sport SPF-50
description: Subjects will be instructed to apply the test article in a split-body and face configuration, to the assigned side of the body (face, arms, torso, and legs), as they normally would before going outdoors for a run, walk or other sport related activity.
arm group label: Sunscreen Users
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Sunscreening Agents