<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/NCT01735201</url>
  </required_header>
  <id_info>
    <org_study_id>199201-002</org_study_id>
    <nct_id>NCT01735201</nct_id>
  </id_info>
  <brief_title>AGN-199201 for the Treatment of Erythema With Rosacea</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Allergan</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Allergan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the safety and efficacy of 3 doses of AGN-199201 once and twice&#xD;
      daily compared to vehicle for the treatment of moderate to severe facial erythema associated&#xD;
      with rosacea.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA)</measure>
    <time_frame>Baseline, Day 28-hours 2 to 12</time_frame>
    <description>Percentage of participants with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score were assessed on Day 28 hours 2 to 12. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both CEA and SSA at 0.5 Hour Post-Dose on Day 28</measure>
    <time_frame>Baseline, Day 28-hour 0.5</time_frame>
    <description>Percentage of participants with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score were assessed at 0.5 hour post-dose on Day 28. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both CEA and SSA at 1 Hour Post-Dose on Day 28</measure>
    <time_frame>Baseline, Day 28-hour 1</time_frame>
    <description>Percentage of participants with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score were assessed at 1 hour post-dose on Day 28. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.</description>
  </secondary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Actual">357</enrollment>
  <condition>Rosacea</condition>
  <condition>Erythema</condition>
  <arm_group>
    <arm_group_label>AGN-199201 Dose A Once Daily</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AGN-199201 Dose A applied once daily to the face for 28 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AGN-199201 Dose B Once Daily</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AGN-199201 Dose B applied once daily to the face for 28 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AGN-199201 Dose C Once Daily</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AGN-199201 Dose C applied once daily to the face for 28 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AGN-199201 Vehicle Once Daily</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>AGN-199201 Vehicle applied once daily to the face for 28 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AGN-199201 Dose A Twice Daily</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AGN-199201 Dose A applied twice daily to the face for 28 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AGN-199201 Dose B Twice Daily</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AGN-199201 Dose B applied twice daily to the face for 28 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AGN-199201 Dose C Twice Daily</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AGN-199201 Dose C applied twice daily to the face for 28 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AGN-199201 Vehicle Twice Daily</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>AGN-199201 Vehicle applied twice daily to the face for 28 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AGN-199201 Dose A</intervention_name>
    <description>AGN-199201 Dose A applied once or twice daily to the face for 28 days.</description>
    <arm_group_label>AGN-199201 Dose A Once Daily</arm_group_label>
    <arm_group_label>AGN-199201 Dose A Twice Daily</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AGN-199201 Dose B</intervention_name>
    <description>AGN-199201 Dose B applied once or twice daily to the face for 28 days.</description>
    <arm_group_label>AGN-199201 Dose B Once Daily</arm_group_label>
    <arm_group_label>AGN-199201 Dose B Twice Daily</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AGN-199201 Dose C</intervention_name>
    <description>AGN-199201 Dose C applied once or twice daily to the face for 28 days.</description>
    <arm_group_label>AGN-199201 Dose C Once Daily</arm_group_label>
    <arm_group_label>AGN-199201 Dose C Twice Daily</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AGN-199201 Vehicle</intervention_name>
    <description>AGN-199201 Vehicle applied once or twice daily to the face for 28 days.</description>
    <arm_group_label>AGN-199201 Vehicle Once Daily</arm_group_label>
    <arm_group_label>AGN-199201 Vehicle Twice Daily</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Redness of the skin caused by rosacea&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ≥3 inflammatory lesions&#xD;
&#xD;
          -  Laser light-source or other energy based therapy in the last 6 months&#xD;
&#xD;
          -  Any prescription or over the counter product for the treatment of acne or rosacea in&#xD;
             the last 14 days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Allergan</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>November 26, 2012</study_first_submitted>
  <study_first_submitted_qc>November 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <results_first_submitted>May 2, 2014</results_first_submitted>
  <results_first_submitted_qc>May 2, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 30, 2014</results_first_posted>
  <last_update_submitted>November 15, 2019</last_update_submitted>
  <last_update_submitted_qc>November 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rosacea</mesh_term>
    <mesh_term>Erythema</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>357 patients were randomized; 1 patient in error. 356 patients were included in the Modified intent-to-treat and Safety populations.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>AGN-199201 Dose A Once Daily</title>
          <description>AGN-199201 Dose A applied once daily to the face for 28 days.</description>
        </group>
        <group group_id="P2">
          <title>AGN-199201 Dose B Once Daily</title>
          <description>AGN-199201 Dose B applied once daily to the face for 28 days.</description>
        </group>
        <group group_id="P3">
          <title>AGN-199201 Dose C Once Daily</title>
          <description>AGN-199201 Dose C applied once daily to the face for 28 days.</description>
        </group>
        <group group_id="P4">
          <title>AGN-199201 Vehicle Once Daily</title>
          <description>AGN-199201 Vehicle applied once daily to the face for 28 days.</description>
        </group>
        <group group_id="P5">
          <title>AGN-199201 Dose A Twice Daily</title>
          <description>AGN-199201 Dose A applied twice daily to the face for 28 days.</description>
        </group>
        <group group_id="P6">
          <title>AGN-199201 Dose B Twice Daily</title>
          <description>AGN-199201 Dose B applied twice daily to the face for 28 days.</description>
        </group>
        <group group_id="P7">
          <title>AGN-199201 Dose C Twice Daily</title>
          <description>AGN-199201 Dose C applied twice daily to the face for 28 days.</description>
        </group>
        <group group_id="P8">
          <title>AGN-199201 Vehicle Twice Daily</title>
          <description>AGN-199201 Vehicle applied twice daily to the face for 28 days.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
                <participants group_id="P2" count="44"/>
                <participants group_id="P3" count="44"/>
                <participants group_id="P4" count="44"/>
                <participants group_id="P5" count="45"/>
                <participants group_id="P6" count="45"/>
                <participants group_id="P7" count="45"/>
                <participants group_id="P8" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="43"/>
                <participants group_id="P3" count="44"/>
                <participants group_id="P4" count="42"/>
                <participants group_id="P5" count="44"/>
                <participants group_id="P6" count="40"/>
                <participants group_id="P7" count="42"/>
                <participants group_id="P8" count="42"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="5"/>
                <participants group_id="P7" count="3"/>
                <participants group_id="P8" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="3"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Personal Reasons</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other Miscellaneous Reasons</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>AGN-199201 Dose A Once Daily</title>
          <description>AGN-199201 Dose A applied once daily to the face for 28 days.</description>
        </group>
        <group group_id="B2">
          <title>AGN-199201 Dose B Once Daily</title>
          <description>AGN-199201 Dose B applied once daily to the face for 28 days.</description>
        </group>
        <group group_id="B3">
          <title>AGN-199201 Dose C Once Daily</title>
          <description>AGN-199201 Dose C applied once daily to the face for 28 days.</description>
        </group>
        <group group_id="B4">
          <title>AGN-199201 Vehicle Once Daily</title>
          <description>AGN-199201 Vehicle applied once daily to the face for 28 days.</description>
        </group>
        <group group_id="B5">
          <title>AGN-199201 Dose A Twice Daily</title>
          <description>AGN-199201 Dose A applied twice daily to the face for 28 days.</description>
        </group>
        <group group_id="B6">
          <title>AGN-199201 Dose B Twice Daily</title>
          <description>AGN-199201 Dose B applied twice daily to the face for 28 days.</description>
        </group>
        <group group_id="B7">
          <title>AGN-199201 Dose C Twice Daily</title>
          <description>AGN-199201 Dose C applied twice daily to the face for 28 days.</description>
        </group>
        <group group_id="B8">
          <title>AGN-199201 Vehicle Twice Daily</title>
          <description>AGN-199201 Vehicle applied twice daily to the face for 28 days.</description>
        </group>
        <group group_id="B9">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="45"/>
            <count group_id="B2" value="44"/>
            <count group_id="B3" value="44"/>
            <count group_id="B4" value="44"/>
            <count group_id="B5" value="45"/>
            <count group_id="B6" value="45"/>
            <count group_id="B7" value="45"/>
            <count group_id="B8" value="44"/>
            <count group_id="B9" value="356"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>&lt; 45 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="16"/>
                    <measurement group_id="B6" value="11"/>
                    <measurement group_id="B7" value="16"/>
                    <measurement group_id="B8" value="9"/>
                    <measurement group_id="B9" value="105"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>45-64 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="28"/>
                    <measurement group_id="B4" value="24"/>
                    <measurement group_id="B5" value="26"/>
                    <measurement group_id="B6" value="29"/>
                    <measurement group_id="B7" value="27"/>
                    <measurement group_id="B8" value="28"/>
                    <measurement group_id="B9" value="215"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;= 65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="5"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="7"/>
                    <measurement group_id="B9" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="33"/>
                    <measurement group_id="B4" value="38"/>
                    <measurement group_id="B5" value="41"/>
                    <measurement group_id="B6" value="34"/>
                    <measurement group_id="B7" value="36"/>
                    <measurement group_id="B8" value="33"/>
                    <measurement group_id="B9" value="285"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="11"/>
                    <measurement group_id="B7" value="9"/>
                    <measurement group_id="B8" value="11"/>
                    <measurement group_id="B9" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA)</title>
        <description>Percentage of participants with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score were assessed on Day 28 hours 2 to 12. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.</description>
        <time_frame>Baseline, Day 28-hours 2 to 12</time_frame>
        <population>Modified intent-to-treat population included all randomized patients who applied study medication during the study, had both CEA and SSA measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA.</population>
        <group_list>
          <group group_id="O1">
            <title>AGN-199201 Dose A Once Daily</title>
            <description>AGN-199201 Dose A applied once daily to the face for 28 days.</description>
          </group>
          <group group_id="O2">
            <title>AGN-199201 Dose B Once Daily</title>
            <description>AGN-199201 Dose B applied once daily to the face for 28 days.</description>
          </group>
          <group group_id="O3">
            <title>AGN-199201 Dose C Once Daily</title>
            <description>AGN-199201 Dose C applied once daily to the face for 28 days.</description>
          </group>
          <group group_id="O4">
            <title>AGN-199201 Vehicle Once Daily</title>
            <description>AGN-199201 Vehicle applied once daily to the face for 28 days.</description>
          </group>
          <group group_id="O5">
            <title>AGN-199201 Dose A Twice Daily</title>
            <description>AGN-199201 Dose A applied twice daily to the face for 28 days.</description>
          </group>
          <group group_id="O6">
            <title>AGN-199201 Dose B Twice Daily</title>
            <description>AGN-199201 Dose B applied twice daily to the face for 28 days.</description>
          </group>
          <group group_id="O7">
            <title>AGN-199201 Dose C Twice Daily</title>
            <description>AGN-199201 Dose C applied twice daily to the face for 28 days.</description>
          </group>
          <group group_id="O8">
            <title>AGN-199201 Vehicle Twice Daily</title>
            <description>AGN-199201 Vehicle applied twice daily to the face for 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA)</title>
          <description>Percentage of participants with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score were assessed on Day 28 hours 2 to 12. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.</description>
          <population>Modified intent-to-treat population included all randomized patients who applied study medication during the study, had both CEA and SSA measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="44"/>
                <count group_id="O4" value="44"/>
                <count group_id="O5" value="45"/>
                <count group_id="O6" value="45"/>
                <count group_id="O7" value="45"/>
                <count group_id="O8" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hour 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.3"/>
                    <measurement group_id="O2" value="20.5"/>
                    <measurement group_id="O3" value="22.7"/>
                    <measurement group_id="O4" value="6.8"/>
                    <measurement group_id="O5" value="8.9"/>
                    <measurement group_id="O6" value="17.8"/>
                    <measurement group_id="O7" value="15.6"/>
                    <measurement group_id="O8" value="6.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.8"/>
                    <measurement group_id="O2" value="31.8"/>
                    <measurement group_id="O3" value="27.3"/>
                    <measurement group_id="O4" value="4.5"/>
                    <measurement group_id="O5" value="11.1"/>
                    <measurement group_id="O6" value="20.0"/>
                    <measurement group_id="O7" value="22.2"/>
                    <measurement group_id="O8" value="6.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.8"/>
                    <measurement group_id="O2" value="22.7"/>
                    <measurement group_id="O3" value="13.6"/>
                    <measurement group_id="O4" value="4.5"/>
                    <measurement group_id="O5" value="11.1"/>
                    <measurement group_id="O6" value="13.3"/>
                    <measurement group_id="O7" value="24.4"/>
                    <measurement group_id="O8" value="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.6"/>
                    <measurement group_id="O2" value="20.5"/>
                    <measurement group_id="O3" value="20.5"/>
                    <measurement group_id="O4" value="4.5"/>
                    <measurement group_id="O5" value="8.9"/>
                    <measurement group_id="O6" value="20.0"/>
                    <measurement group_id="O7" value="20.0"/>
                    <measurement group_id="O8" value="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.8"/>
                    <measurement group_id="O2" value="20.5"/>
                    <measurement group_id="O3" value="13.6"/>
                    <measurement group_id="O4" value="4.5"/>
                    <measurement group_id="O5" value="13.3"/>
                    <measurement group_id="O6" value="15.6"/>
                    <measurement group_id="O7" value="26.7"/>
                    <measurement group_id="O8" value="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.3"/>
                    <measurement group_id="O2" value="13.6"/>
                    <measurement group_id="O3" value="13.6"/>
                    <measurement group_id="O4" value="2.3"/>
                    <measurement group_id="O5" value="13.3"/>
                    <measurement group_id="O6" value="11.1"/>
                    <measurement group_id="O7" value="15.6"/>
                    <measurement group_id="O8" value="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both CEA and SSA at 0.5 Hour Post-Dose on Day 28</title>
        <description>Percentage of participants with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score were assessed at 0.5 hour post-dose on Day 28. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.</description>
        <time_frame>Baseline, Day 28-hour 0.5</time_frame>
        <population>Modified intent-to-treat population included all randomized patients who applied study medication during the study, had both CEA and SSA measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA.</population>
        <group_list>
          <group group_id="O1">
            <title>AGN-199201 Dose A Once Daily</title>
            <description>AGN-199201 Dose A applied once daily to the face for 28 days.</description>
          </group>
          <group group_id="O2">
            <title>AGN-199201 Dose B Once Daily</title>
            <description>AGN-199201 Dose B applied once daily to the face for 28 days.</description>
          </group>
          <group group_id="O3">
            <title>AGN-199201 Dose C Once Daily</title>
            <description>AGN-199201 Dose C applied once daily to the face for 28 days.</description>
          </group>
          <group group_id="O4">
            <title>AGN-199201 Vehicle Once Daily</title>
            <description>AGN-199201 Vehicle applied once daily to the face for 28 days.</description>
          </group>
          <group group_id="O5">
            <title>AGN-199201 Dose A Twice Daily</title>
            <description>AGN-199201 Dose A applied twice daily to the face for 28 days.</description>
          </group>
          <group group_id="O6">
            <title>AGN-199201 Dose B Twice Daily</title>
            <description>AGN-199201 Dose B applied twice daily to the face for 28 days.</description>
          </group>
          <group group_id="O7">
            <title>AGN-199201 Dose C Twice Daily</title>
            <description>AGN-199201 Dose C applied twice daily to the face for 28 days.</description>
          </group>
          <group group_id="O8">
            <title>AGN-199201 Vehicle Twice Daily</title>
            <description>AGN-199201 Vehicle applied twice daily to the face for 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both CEA and SSA at 0.5 Hour Post-Dose on Day 28</title>
          <description>Percentage of participants with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score were assessed at 0.5 hour post-dose on Day 28. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.</description>
          <population>Modified intent-to-treat population included all randomized patients who applied study medication during the study, had both CEA and SSA measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="44"/>
                <count group_id="O4" value="44"/>
                <count group_id="O5" value="45"/>
                <count group_id="O6" value="45"/>
                <count group_id="O7" value="45"/>
                <count group_id="O8" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7"/>
                    <measurement group_id="O2" value="11.4"/>
                    <measurement group_id="O3" value="6.8"/>
                    <measurement group_id="O4" value="4.5"/>
                    <measurement group_id="O5" value="6.7"/>
                    <measurement group_id="O6" value="6.7"/>
                    <measurement group_id="O7" value="6.7"/>
                    <measurement group_id="O8" value="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both CEA and SSA at 1 Hour Post-Dose on Day 28</title>
        <description>Percentage of participants with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score were assessed at 1 hour post-dose on Day 28. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.</description>
        <time_frame>Baseline, Day 28-hour 1</time_frame>
        <population>Modified intent-to-treat population included all randomized patients who applied study medication during the study, had both CEA and SSA measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA.</population>
        <group_list>
          <group group_id="O1">
            <title>AGN-199201 Dose A Once Daily</title>
            <description>AGN-199201 Dose A applied once daily to the face for 28 days.</description>
          </group>
          <group group_id="O2">
            <title>AGN-199201 Dose B Once Daily</title>
            <description>AGN-199201 Dose B applied once daily to the face for 28 days.</description>
          </group>
          <group group_id="O3">
            <title>AGN-199201 Dose C Once Daily</title>
            <description>AGN-199201 Dose C applied once daily to the face for 28 days.</description>
          </group>
          <group group_id="O4">
            <title>AGN-199201 Vehicle Once Daily</title>
            <description>AGN-199201 Vehicle applied once daily to the face for 28 days.</description>
          </group>
          <group group_id="O5">
            <title>AGN-199201 Dose A Twice Daily</title>
            <description>AGN-199201 Dose A applied twice daily to the face for 28 days.</description>
          </group>
          <group group_id="O6">
            <title>AGN-199201 Dose B Twice Daily</title>
            <description>AGN-199201 Dose B applied twice daily to the face for 28 days.</description>
          </group>
          <group group_id="O7">
            <title>AGN-199201 Dose C Twice Daily</title>
            <description>AGN-199201 Dose C applied twice daily to the face for 28 days.</description>
          </group>
          <group group_id="O8">
            <title>AGN-199201 Vehicle Twice Daily</title>
            <description>AGN-199201 Vehicle applied twice daily to the face for 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both CEA and SSA at 1 Hour Post-Dose on Day 28</title>
          <description>Percentage of participants with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score were assessed at 1 hour post-dose on Day 28. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.</description>
          <population>Modified intent-to-treat population included all randomized patients who applied study medication during the study, had both CEA and SSA measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="44"/>
                <count group_id="O4" value="44"/>
                <count group_id="O5" value="45"/>
                <count group_id="O6" value="45"/>
                <count group_id="O7" value="45"/>
                <count group_id="O8" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.1"/>
                    <measurement group_id="O2" value="13.6"/>
                    <measurement group_id="O3" value="18.2"/>
                    <measurement group_id="O4" value="2.3"/>
                    <measurement group_id="O5" value="6.7"/>
                    <measurement group_id="O6" value="11.1"/>
                    <measurement group_id="O7" value="8.9"/>
                    <measurement group_id="O8" value="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>AGN-199201 Dose A Once Daily</title>
          <description>AGN-199201 Dose A applied once daily to the face for 28 days.</description>
        </group>
        <group group_id="E2">
          <title>AGN-199201 Dose B Once Daily</title>
          <description>AGN-199201 Dose B applied once daily to the face for 28 days.</description>
        </group>
        <group group_id="E3">
          <title>AGN-199201 Dose C Once Daily</title>
          <description>AGN-199201 Dose C applied once daily to the face for 28 days.</description>
        </group>
        <group group_id="E4">
          <title>AGN-199201 Vehicle Once Daily</title>
          <description>AGN-199201 Vehicle applied once daily to the face for 28 days.</description>
        </group>
        <group group_id="E5">
          <title>AGN-199201 Dose A Twice Daily</title>
          <description>AGN-199201 Dose A applied twice daily to the face for 28 days.</description>
        </group>
        <group group_id="E6">
          <title>AGN-199201 Dose B Twice Daily</title>
          <description>AGN-199201 Dose B applied twice daily to the face for 28 days.</description>
        </group>
        <group group_id="E7">
          <title>AGN-199201 Dose C Twice Daily</title>
          <description>AGN-199201 Dose C applied twice daily to the face for 28 days.</description>
        </group>
        <group group_id="E8">
          <title>AGN-199201 Vehicle Twice Daily</title>
          <description>AGN-199201 Vehicle applied twice daily to the face for 28 days.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 16.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <description>Event not related to study treatment.</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Chondrocalcinosis pyrophosphate</sub_title>
                <description>Event not related to study treatment.</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Rotator cuff syndrome</sub_title>
                <description>Event not related to study treatment.</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <description>Event not related to study treatment.</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <description>Event not related to study treatment.</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 16.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="45"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="44"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="45"/>
                <counts group_id="E7" subjects_affected="7" subjects_at_risk="45"/>
                <counts group_id="E8" subjects_affected="6" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Application site dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="44"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Application site acne</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="45"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="45"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Therapeutic Area Head,</name_or_title>
      <organization>Allergan, Inc</organization>
      <phone>714-246-4500</phone>
      <email>clinicaltrials@allergan.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01735201
org study id: 199201-002
nct id: NCT01735201
lead sponsor: 
has dmc: No
This study will evaluate the safety and efficacy of 3 doses of AGN-199201 once and twice
      daily compared to vehicle for the treatment of moderate to severe facial erythema associated
      with rosacea.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA)
time frame: Baseline, Day 28-hours 2 to 12
description: Percentage of participants with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score were assessed on Day 28 hours 2 to 12. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.
measure: Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both CEA and SSA at 0.5 Hour Post-Dose on Day 28
time frame: Baseline, Day 28-hour 0.5
description: Percentage of participants with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score were assessed at 0.5 hour post-dose on Day 28. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.
measure: Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both CEA and SSA at 1 Hour Post-Dose on Day 28
time frame: Baseline, Day 28-hour 1
description: Percentage of participants with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score were assessed at 1 hour post-dose on Day 28. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.
arm group label: AGN-199201 Dose A Once Daily
arm group type: Experimental
description: AGN-199201 Dose A applied once daily to the face for 28 days.
arm group label: AGN-199201 Dose B Once Daily
arm group type: Experimental
description: AGN-199201 Dose B applied once daily to the face for 28 days.
arm group label: AGN-199201 Dose C Once Daily
arm group type: Experimental
description: AGN-199201 Dose C applied once daily to the face for 28 days.
arm group label: AGN-199201 Vehicle Once Daily
arm group type: Placebo Comparator
description: AGN-199201 Vehicle applied once daily to the face for 28 days.
arm group label: AGN-199201 Dose A Twice Daily
arm group type: Experimental
description: AGN-199201 Dose A applied twice daily to the face for 28 days.
arm group label: AGN-199201 Dose B Twice Daily
arm group type: Experimental
description: AGN-199201 Dose B applied twice daily to the face for 28 days.
arm group label: AGN-199201 Dose C Twice Daily
arm group type: Experimental
description: AGN-199201 Dose C applied twice daily to the face for 28 days.
arm group label: AGN-199201 Vehicle Twice Daily
arm group type: Placebo Comparator
description: AGN-199201 Vehicle applied twice daily to the face for 28 days.
intervention type: Drug
intervention name: AGN-199201 Dose A
description: AGN-199201 Dose A applied once or twice daily to the face for 28 days.
arm group label: AGN-199201 Dose A Once Daily
arm group label: AGN-199201 Dose A Twice Daily
intervention type: Drug
intervention name: AGN-199201 Dose B
description: AGN-199201 Dose B applied once or twice daily to the face for 28 days.
arm group label: AGN-199201 Dose B Once Daily
arm group label: AGN-199201 Dose B Twice Daily
intervention type: Drug
intervention name: AGN-199201 Dose C
description: AGN-199201 Dose C applied once or twice daily to the face for 28 days.
arm group label: AGN-199201 Dose C Once Daily
arm group label: AGN-199201 Dose C Twice Daily
intervention type: Drug
intervention name: AGN-199201 Vehicle
description: AGN-199201 Vehicle applied once or twice daily to the face for 28 days.
arm group label: AGN-199201 Vehicle Once Daily
arm group label: AGN-199201 Vehicle Twice Daily
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Allergan
facility: 
country: United States
responsible party type: Sponsor
mesh term: Rosacea
mesh term: Erythema
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 