<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/NCT03841032</url>
  </required_header>
  <id_info>
    <org_study_id>20516</org_study_id>
    <nct_id>NCT03841032</nct_id>
  </id_info>
  <brief_title>4 Week In-Use Study Evaluating How Well-Tolerated a Skin Care Product Is on Adults With Facial Redness</brief_title>
  <official_title>4 Week In-Use Study Evaluating the Tolerability of a Skin Care Product on Adults With Rosacea</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate if the test sunscreen skin care product will be&#xD;
      well-tolerated and help facial redness when applied to the face after 4 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 28, 2019</start_date>
  <completion_date type="Actual">February 25, 2019</completion_date>
  <primary_completion_date type="Actual">February 25, 2019</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of subjects exhibiting increases in papules</measure>
    <time_frame>Up to 4 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects exhibiting increases in erythema</measure>
    <time_frame>Up to 4 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects exhibiting increases in dryness, telangiectasia and tactile surface roughness</measure>
    <time_frame>Up to 4 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects exhibiting increases in any subjective irritation</measure>
    <time_frame>Up to 4 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in facial redness measured by spectrophotometer</measure>
    <time_frame>From baseline up to 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in facial redness measured by digital imaging</measure>
    <time_frame>From baseline up to 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentages for each response to hedonic questionnaire assessing product experience</measure>
    <time_frame>Up to 4 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Rosacea</condition>
  <arm_group>
    <arm_group_label>Sunscreen Lotion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects with rosacea will apply the test sunscreen lotion to the face for 4 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Coppertone, BAY1183345</intervention_name>
    <description>Lotion, for 4 weeks</description>
    <arm_group_label>Sunscreen Lotion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or females at least 18 years of age;&#xD;
&#xD;
          -  Women of childbearing potential must agree to use adequate contraception when sexually&#xD;
             active. Acceptable methods of contraception include, but are not limited to, (i)&#xD;
             condoms (male or female) with or without a spermicidal agent; (ii) diaphragm or&#xD;
             cervical cap with spermicide; (iii) intra-uterine device; (iv) hormone-based&#xD;
             contraception (stable dose for 3 months); (v) partner vasectomy.&#xD;
&#xD;
          -  Subjects with general good health as determined by a medical history form;&#xD;
&#xD;
          -  Subjects with erythematotelangiectatic and/or papulopustular rosacea, at the baseline&#xD;
             evaluation, as determined by the Investigator;&#xD;
&#xD;
          -  Subjects with Fitzpatrick Skin Types I through III, as determined by the&#xD;
             dermatologist;&#xD;
&#xD;
          -  Subjects willing and capable of understanding and providing written informed consent,&#xD;
             willing to sign a confidentiality agreement, Health Insurance Portability and&#xD;
             Accountability Act (HIPAA) Authorization Form, and to cooperate and participate by&#xD;
             following study requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with only phymatous or ocular rosacea;&#xD;
&#xD;
          -  Female subjects of child-bearing potential who test positive in a urine pregnancy test&#xD;
             at Baseline (Visit 1), are trying to become pregnant or are nursing;&#xD;
&#xD;
          -  Subjects with known allergies to any type of skin care product and/or sunscreen&#xD;
             product and/or any ingredients in the test product;&#xD;
&#xD;
          -  Subjects with any facial skin disorders which may influence results, in the opinion of&#xD;
             the Investigator;&#xD;
&#xD;
          -  Subjects with a reported history of acute or chronic dermatological (except for&#xD;
             rosacea), uncontrolled hypertension, other medical and/or physical conditions which,&#xD;
             in the opinion of the Investigator, interferes with evaluation of the test product or&#xD;
             places the subject at risk;&#xD;
&#xD;
          -  Subjects currently using medications or oral supplements which, in the opinion of the&#xD;
             Investigator, may influence the outcome of the study or interfere with study&#xD;
             observations, including rosacea treatment products;&#xD;
&#xD;
          -  Individuals using or who have used any systemic medication considered to affect&#xD;
             rosacea, specifically, but not exclusively, antibiotics or steroids, who do not agree&#xD;
             to continue taking the specified medication at the same dose and regimen throughout&#xD;
             the study;&#xD;
&#xD;
          -  Subjects who started hormone replacement therapies (HRT) or hormones for birth control&#xD;
             less than 3 months prior to study entry or who plan on starting, stopping, or changing&#xD;
             doses of HRT or hormones for birth control during the study;&#xD;
&#xD;
          -  Subjects with excessive facial hair that would, in the opinion of the Investigator,&#xD;
             interfere with diagnosis or assessment of rosacea;&#xD;
&#xD;
          -  Subjects who spend excessive time out in the sun;&#xD;
&#xD;
          -  Subjects that have received or used an Investigational New Drug within 30 days prior&#xD;
             to the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The Education &amp; Research Foundation, Inc.</name>
      <address>
        <city>Lynchburg</city>
        <state>Virginia</state>
        <zip>24501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>June 11, 2019</last_update_submitted>
  <last_update_submitted_qc>June 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Facial redness</keyword>
  <keyword>Skin sensitivity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rosacea</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA &quot;Principles for responsible clinical trial data sharing&quot;. This pertains to scope, timepoint and process of data access.&#xD;
As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.&#xD;
Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.</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/NCT03841032
org study id: 20516
nct id: NCT03841032
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
The purpose of this study is to evaluate if the test sunscreen skin care product will be
      well-tolerated and help facial redness when applied to the face after 4 weeks.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Number of subjects exhibiting increases in papules
time frame: Up to 4 weeks
measure: Number of subjects exhibiting increases in erythema
time frame: Up to 4 weeks
measure: Number of subjects exhibiting increases in dryness, telangiectasia and tactile surface roughness
time frame: Up to 4 weeks
measure: Number of subjects exhibiting increases in any subjective irritation
time frame: Up to 4 weeks
measure: Change in facial redness measured by spectrophotometer
time frame: From baseline up to 4 weeks
measure: Change in facial redness measured by digital imaging
time frame: From baseline up to 4 weeks
measure: Percentages for each response to hedonic questionnaire assessing product experience
time frame: Up to 4 weeks
arm group label: Sunscreen Lotion
arm group type: Experimental
description: Subjects with rosacea will apply the test sunscreen lotion to the face for 4 weeks
intervention type: Drug
intervention name: Coppertone, BAY1183345
description: Lotion, for 4 weeks
arm group label: Sunscreen Lotion
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Rosacea
sharing ipd: Undecided
ipd description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.
As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.