<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/NCT02995018</url>
  </required_header>
  <id_info>
    <org_study_id>19317</org_study_id>
    <nct_id>NCT02995018</nct_id>
  </id_info>
  <brief_title>Sun Protection Factor Assay (317/2016)</brief_title>
  <acronym>SPF Assay</acronym>
  <official_title>Sun Protection Factor (SPF) Assay : UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose</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 evaluate the Sun Protection Factor efficacy on human skin.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 3, 2017</start_date>
  <completion_date type="Actual">January 25, 2017</completion_date>
  <primary_completion_date type="Actual">January 25, 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>Minimal Erythema Dose (MED)</measure>
    <time_frame>Up to 15 minutes</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Minimal Persistent Pigment Darkening Dose (MPPD)</measure>
    <time_frame>Up to 15 minutes</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Sunscreening Agents</condition>
  <arm_group>
    <arm_group_label>SPF evaluation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each test site area is divided into test sub site areas that are approximately at least 0.5 cm*2. The application of test material is 2 mg/cm*2. Thus, each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BAY987521</intervention_name>
    <description>Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code: Z09-174)</description>
    <arm_group_label>SPF evaluation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SPF Control</intervention_name>
    <description>Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.</description>
    <arm_group_label>SPF evaluation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll&#xD;
             and/or lV for UVA testing.&#xD;
&#xD;
          -  Male and female.&#xD;
&#xD;
          -  Aged between 18-70 years old.&#xD;
&#xD;
          -  Good health as determined from the HRL SHF (Subject History Form).&#xD;
&#xD;
          -  Signed and dated Informed Consent Form&#xD;
&#xD;
          -  Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.&#xD;
&#xD;
          -  An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment&#xD;
             Darkening Dose).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects on test at any other research laboratory or clinic.&#xD;
&#xD;
          -  Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs&#xD;
             and/or ultraviolet light.&#xD;
&#xD;
          -  Pre-existing dermatologic conditions which have been diagnosed by a medical&#xD;
             professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.&#xD;
&#xD;
          -  Pre-existing other medical conditions (e.g. adult asthma, diabetes).&#xD;
&#xD;
          -  Treatment with antihistamines or corticosteroids within one week prior to initiation&#xD;
             of the test.&#xD;
&#xD;
          -  Treatment with antibiotics within two weeks prior to initiation of the test.&#xD;
&#xD;
          -  Chronic medication which could affect the results of the study.&#xD;
&#xD;
          -  Known pregnant or nursing women.&#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>
  <location>
    <facility>
      <address>
        <city>Union</city>
        <state>New Jersey</state>
        <zip>07083</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>February 24, 2018</last_update_submitted>
  <last_update_submitted_qc>February 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 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/NCT02995018
org study id: 19317
nct id: NCT02995018
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To evaluate the Sun Protection Factor efficacy on human skin.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Minimal Erythema Dose (MED)
time frame: Up to 15 minutes
measure: Minimal Persistent Pigment Darkening Dose (MPPD)
time frame: Up to 15 minutes
arm group label: SPF evaluation
arm group type: Experimental
description: Each test site area is divided into test sub site areas that are approximately at least 0.5 cm*2. The application of test material is 2 mg/cm*2. Thus, each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.
intervention type: Drug
intervention name: BAY987521
description: Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code: Z09-174)
arm group label: SPF evaluation
intervention type: Drug
intervention name: SPF Control
description: Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.
arm group label: SPF evaluation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor