<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/NCT03002922</url>
  </required_header>
  <id_info>
    <org_study_id>18821</org_study_id>
    <nct_id>NCT03002922</nct_id>
  </id_info>
  <brief_title>Evaluation of Sunscreen During Exercise Under Conditions of Profuse Sweating (821/2016)</brief_title>
  <official_title>Evaluation of Sunscreen During Exercise Under Conditions of Profuse Sweating</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 visually evaluate the retention of coverage of the Test Product(s) (TP) on the face after&#xD;
      exercise compared to the full coverage observed prior to exercise&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 18, 2017</start_date>
  <completion_date type="Actual">January 28, 2017</completion_date>
  <primary_completion_date type="Actual">January 28, 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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of face coverage post exercise compared to the full coverage observed prior to exercise (in percent)</measure>
    <time_frame>At baseline, and post exercise (30 minutes)</time_frame>
    <description>The expert grader will determine the percentage of coverage achieved by viewing the subject's face through the Skin Scanner</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Report of eye stinging assessed by questionnaire</measure>
    <time_frame>Up to 30 minutes</time_frame>
    <description>Subjective assessment of eye stinging (where 0=none to 4=severe)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Sunscreening Agents</condition>
  <arm_group>
    <arm_group_label>Healthy subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subject will self-apply the test sunscreen formula to his/her face with the goal of applying 0.65 to 0.85 grams. Subject should sweat profusely.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BAY987517</intervention_name>
    <description>Sunscreen formula Y65-158</description>
    <arm_group_label>Healthy subjects</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects may be male or female, of an age of 18-55 years inclusive. Subjects must be&#xD;
        capable of understanding and providing written informed consent.&#xD;
&#xD;
        Subjects must sign a written confidentiality agreement including a photography release&#xD;
        form.&#xD;
&#xD;
        Subjects must be in good general health as judged by a specified licensed physician, who&#xD;
        will indicate their suitability to participate in this study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects must not have received or used an Investigational New Drug within the last 30&#xD;
        days.&#xD;
&#xD;
        Subjects must not have been active participants in another clinical or subjective TP&#xD;
        performance study within the last 30 days unless authorized by this Sponsor. Subjects must&#xD;
        not have a known physical or medical condition that would preclude vigorous exercise&#xD;
        Subjects must not have a five-minute resting pulse rate greater than 80 bpm.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bayer Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Bayer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hill Top Research</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33714</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 26, 2016</study_first_posted>
  <last_update_submitted>January 25, 2018</last_update_submitted>
  <last_update_submitted_qc>January 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2018</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/NCT03002922
org study id: 18821
nct id: NCT03002922
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To visually evaluate the retention of coverage of the Test Product(s) (TP) on the face after
      exercise compared to the full coverage observed prior to exercise
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change of face coverage post exercise compared to the full coverage observed prior to exercise (in percent)
time frame: At baseline, and post exercise (30 minutes)
description: The expert grader will determine the percentage of coverage achieved by viewing the subject's face through the Skin Scanner
measure: Report of eye stinging assessed by questionnaire
time frame: Up to 30 minutes
description: Subjective assessment of eye stinging (where 0=none to 4=severe)
arm group label: Healthy subjects
arm group type: Experimental
description: Subject will self-apply the test sunscreen formula to his/her face with the goal of applying 0.65 to 0.85 grams. Subject should sweat profusely.
intervention type: Drug
intervention name: BAY987517
description: Sunscreen formula Y65-158
arm group label: Healthy subjects
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bayer Study Director
role: Study Director
affiliation: Bayer
facility: 
country: United States
responsible party type: Sponsor