<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/NCT02249065</url>
  </required_header>
  <id_info>
    <org_study_id>GLI.04.SPR.US 10305</org_study_id>
    <nct_id>NCT02249065</nct_id>
  </id_info>
  <brief_title>Mirvaso in Use Study</brief_title>
  <official_title>MIRVASO® In Use Study: Managing Rosacea Through Assessment and Control of Its Erythema (The MIRACLE Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Galderma R&amp;D</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Galderma R&amp;D</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to:&#xD;
&#xD;
        1. assess the signs and symptoms of rosacea, including erythema, without treatment and&#xD;
           during treatment with Mirvaso® gel&#xD;
&#xD;
        2. further characterize lifestyle impact and patient satisfaction with Mirvaso® treatment&#xD;
&#xD;
        3. gain a better understanding of the real-world use of Mirvaso® on the pattern and&#xD;
           management of facial erythema of rosacea.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pre-Treatment Clinician Erythema Assessment (CEA)</measure>
    <time_frame>14 days (Day 1 (Baseline), Day 7, and Day 14/Exit)</time_frame>
    <description>The number and percent of subjects in each CEA score category at each visit. CEA was conducted at the screening/baseline visit and all subsequent visits prior to the study drug application.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subject Facial Redness Questionnaire</measure>
    <time_frame>14 days (Day 1 (Baseline) and Day 14/Exit)</time_frame>
    <description>Facial Redness Questionnaire at Day 1 and Day 14 (Mean Number of Subjects Who's Responses Indicate They Were/Were Not Bothered By Facial Redness, Across All 11 Facial Redness Questions)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject Treatment Satisfaction Questionnaire</measure>
    <time_frame>14 days (Day 14/Exit)</time_frame>
    <description>Mean Subject Treatment Satisfaction at Day 14 (Average Response Across 12 Questions)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Facial Redness Visual Analog Scale (VAS)</measure>
    <time_frame>14 days (Day 1 (Baseline), Day 14/Exit)</time_frame>
    <description>The number and percent of subjects in each transformed response category for the in-office subject reported facial redness VAS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory Lesions</measure>
    <time_frame>14 days (Day 1 (Baseline) and Day 14/Exit)</time_frame>
    <description>Change from baseline in facial inflammatory lesion count</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">205</enrollment>
  <condition>Rosacea</condition>
  <arm_group>
    <arm_group_label>Mirvaso Gel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Brimonidine topical gel, 0.33%</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Brimonidine</intervention_name>
    <arm_group_label>Mirvaso Gel</arm_group_label>
    <other_name>Mirvaso Gel</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects must be 18 years of age or older at time of study consent.&#xD;
&#xD;
          2. Subjects with a board certified dermatologist (BCD) clinical diagnosis of facial&#xD;
             erythema of rosacea and eligible for treatment with Mirvaso® (brimonidine) topical&#xD;
             gel, 0.33% per package insert.&#xD;
&#xD;
          3. Subjects with a clinician's erythema assessment (CEA) score of ~3 at Screening Visit&#xD;
             1.&#xD;
&#xD;
          4. Subjects with less than 3 facial inflammatory lesions of rosacea at Screening/Visit 1.&#xD;
&#xD;
          5. Subjects must be willing and able to give written informed consent including&#xD;
             photography consent. Consent and photo consent will be obtained prior to any study&#xD;
             related procedures&#xD;
&#xD;
          6. Females of childbearing potential with a negative urine pregnancy test (UPT) at Visit&#xD;
             1 (prior to test article application) or females of non-childbearing potential (deemed&#xD;
             as post-menopausal [absence of menstrual bleeding for at least 1 year prior to&#xD;
             enrollment], hysterectomy or bilateral oophorectomy).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects with particular forms of rosacea (rosacea conglobata, rosacea fulminans,&#xD;
             isolated rhinophyma, isolated pustulosis of the chin) or other concomitant facial&#xD;
             dermatoses that are similar to rosacea such as peri-oral dermatitis, demodicidosis,&#xD;
             facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic&#xD;
             telangiectasia.&#xD;
&#xD;
          2. Subjects with current diagnosis of Raynaud's syndrome, thromboangiitis obliterans,&#xD;
             orthostatic hypotension, severe cardiovascular disease, cerebral or coronary&#xD;
             insufficiency, renal or hepatic impairment, scleroderma, Sjogren's syndrome or&#xD;
             depression.&#xD;
&#xD;
          3. Subjects with previous refractive eye surgery such as photorefractive keratectomy,&#xD;
             laser-assisted sub-epithelial keratectomy, or laser-assisted in situ keratomileusis.&#xD;
&#xD;
          4. Current treatment with monoamine oxidase inhibitors.&#xD;
&#xD;
          5. Current treatment with barbiturates, opiates, sedatives, systemic anesthetics, or&#xD;
             alpha- agonists.&#xD;
&#xD;
          6. Less than 3 months (90 days) stable dose treatment with tricyclic antidepressants,&#xD;
             cardiac glycosides, beta blockers or other antihypertensive agents.&#xD;
&#xD;
          7. Subjects with any uncontrolled chronic or serious disease or medical condition that&#xD;
             would normally prevent participation in a clinical study, or, in the judgment of the&#xD;
             investigator, would put the subjects at undue risk, or might confound the study&#xD;
             assessments (e.g., other dermatological diseases), or might interfere with the&#xD;
             subjects' participation in the study, (e.g., planned hospitalization during the&#xD;
             study).&#xD;
&#xD;
          8. Subjects who have received, applied, or taken treatments with drugs, cosmetics or&#xD;
             devices known to cause facial erythema and who are deemed ineligible by the&#xD;
             investigator.&#xD;
&#xD;
          9. Subjects with known allergies or sensitivities to any component of the study drug,&#xD;
             including the active ingredient brimonidine tartrate label (refer to the package&#xD;
             insert for Mirvaso® (brimonidine) topical gel, 0.33%).&#xD;
&#xD;
         10. Subjects with prior treatment with brimonidine gel, oxymetazoline or other (topical&#xD;
             and/or systemic) alpha adrenergic agonists.&#xD;
&#xD;
         11. Subjects who are pregnant or breast-feeding or planning to become pregnant during the&#xD;
             course of the study.&#xD;
&#xD;
         12. Subjects exposed to excessive ultraviolet (UV) radiation within I week prior to&#xD;
             baseline and/or subject was unwilling to refrain from excessive exposure to UV&#xD;
             radiation during the course of the study.&#xD;
&#xD;
         13. Subjects with the presence of a beard or excessive facial hair that would interfere&#xD;
             with the study treatments or study assessments as deemed by the investigator, and&#xD;
             refusal to remove beard or facial hair for duration of the study.&#xD;
&#xD;
         14. Subjects with non-stable dose of current (last 60 days) use of prescription rosacea&#xD;
             medications.&#xD;
&#xD;
         15. Subjects with uncontrolled rosacea associated with inflammatory pustules and papules.&#xD;
&#xD;
         16. Study site staff, relatives of staff members, or other individuals who would have&#xD;
             access to the clinical study protocol.&#xD;
&#xD;
         17. Subjects with participation in any investigational study within 30 days of entry into&#xD;
             this study or concomitantly with this 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>
  <overall_official>
    <last_name>Jeffrey Sugarman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Redwood Dermatology Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johnson Dermatology</name>
      <address>
        <city>Fort Smith</city>
        <state>Arkansas</state>
        <zip>72916</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Blue Harbor Dermatology</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92663</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Dermatology and Laser Surgery</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95819</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Redwood Dermatology Research</name>
      <address>
        <city>Santa Rosa</city>
        <state>California</state>
        <zip>95403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Academic Dermatology Center</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Institute of the Southeast</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grekin Skin Institute</name>
      <address>
        <city>Warren</city>
        <state>Michigan</state>
        <zip>48088</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Skin Research Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Manhattan Dermatology and Cosmetic Surgery</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DermDox Centers for Dermatology</name>
      <address>
        <city>Hazleton</city>
        <state>Pennsylvania</state>
        <zip>18201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arlington Research Center</name>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <zip>76011</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Dermatology and Laser Specialists</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <results_first_submitted>September 19, 2017</results_first_submitted>
  <results_first_submitted_qc>September 19, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">October 19, 2017</results_first_posted>
  <last_update_submitted>July 28, 2022</last_update_submitted>
  <last_update_submitted_qc>July 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2022</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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brimonidine Tartrate</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Mirvaso Gel</title>
          <description>Brimonidine Gel (topical emulsion (gel), 0.33% brimonidine, once daily)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="205"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="181"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="176"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>ITT Population, Subjects who received at least 1 application of study drug, and completed at least 1 assessment</population>
      <group_list>
        <group group_id="B1">
          <title>Mirvaso Gel</title>
          <description>Brimonidine Gel</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="181"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="143"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52.4" lower_limit="22.0" upper_limit="85.0"/>
                  </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="136"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="181"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pre-Treatment Clinician Erythema Assessment (CEA)</title>
        <description>The number and percent of subjects in each CEA score category at each visit. CEA was conducted at the screening/baseline visit and all subsequent visits prior to the study drug application.</description>
        <time_frame>14 days (Day 1 (Baseline), Day 7, and Day 14/Exit)</time_frame>
        <population>Intent-to-treat (ITT) Population; Subjects who received at least 1 application of study drug, and completed at least 1 assessment</population>
        <group_list>
          <group group_id="O1">
            <title>Mirvaso Gel</title>
            <description>Brimonidine Gel</description>
          </group>
        </group_list>
        <measure>
          <title>Pre-Treatment Clinician Erythema Assessment (CEA)</title>
          <description>The number and percent of subjects in each CEA score category at each visit. CEA was conducted at the screening/baseline visit and all subsequent visits prior to the study drug application.</description>
          <population>Intent-to-treat (ITT) Population; Subjects who received at least 1 application of study drug, and completed at least 1 assessment</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="181"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1 (Baseline)</title>
              <category_list>
                <category>
                  <title>Clear Skin</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Almost Clear</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild Erythema</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate Erythema</title>
                  <measurement_list>
                    <measurement group_id="O1" value="144"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe Erythema</title>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <category_list>
                <category>
                  <title>Clear Skin</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Almost Clear</title>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild Erythema</title>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate Erythema</title>
                  <measurement_list>
                    <measurement group_id="O1" value="84"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe Erythema</title>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <category_list>
                <category>
                  <title>Clear Skin</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Almost Clear</title>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild Erythema</title>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate Erythema</title>
                  <measurement_list>
                    <measurement group_id="O1" value="86"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe Erythema</title>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject Facial Redness Questionnaire</title>
        <description>Facial Redness Questionnaire at Day 1 and Day 14 (Mean Number of Subjects Who's Responses Indicate They Were/Were Not Bothered By Facial Redness, Across All 11 Facial Redness Questions)</description>
        <time_frame>14 days (Day 1 (Baseline) and Day 14/Exit)</time_frame>
        <population>ITT Population, Subjects who received at least 1 application of study drug, and completed at least 1 assessment</population>
        <group_list>
          <group group_id="O1">
            <title>Mirvaso Gel</title>
            <description>Brimonidine Gel</description>
          </group>
        </group_list>
        <measure>
          <title>Subject Facial Redness Questionnaire</title>
          <description>Facial Redness Questionnaire at Day 1 and Day 14 (Mean Number of Subjects Who's Responses Indicate They Were/Were Not Bothered By Facial Redness, Across All 11 Facial Redness Questions)</description>
          <population>ITT Population, Subjects who received at least 1 application of study drug, and completed at least 1 assessment</population>
          <units>Participants</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="181"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Not Bothered (Mean [SD], Day 1, Baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.3" spread="39.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bothered (Mean [SD], Day 1, Baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="104.7" spread="40.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing (Day 1, Baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Bothered (Mean [SD], Day 14)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="112.6" spread="28.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bothered (Mean [SD], Day 14)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.3" spread="26.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing (Day 14)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread=".3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject Treatment Satisfaction Questionnaire</title>
        <description>Mean Subject Treatment Satisfaction at Day 14 (Average Response Across 12 Questions)</description>
        <time_frame>14 days (Day 14/Exit)</time_frame>
        <population>ITT Population, Subjects who received at least 1 application of study drug, and completed at least 1 assessment</population>
        <group_list>
          <group group_id="O1">
            <title>Mirvaso Gel</title>
            <description>Brimonidine Gel</description>
          </group>
        </group_list>
        <measure>
          <title>Subject Treatment Satisfaction Questionnaire</title>
          <description>Mean Subject Treatment Satisfaction at Day 14 (Average Response Across 12 Questions)</description>
          <population>ITT Population, Subjects who received at least 1 application of study drug, and completed at least 1 assessment</population>
          <units>Participants</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="181"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Satisfied Participants (Mean [SD])</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="127.3" spread="22.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dissatisfied Participants (Mean [SD])</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.7" spread="22.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Facial Redness Visual Analog Scale (VAS)</title>
        <description>The number and percent of subjects in each transformed response category for the in-office subject reported facial redness VAS</description>
        <time_frame>14 days (Day 1 (Baseline), Day 14/Exit)</time_frame>
        <population>ITT Population, Subjects who received at least 1 application of study drug, and completed at least 1 assessment</population>
        <group_list>
          <group group_id="O1">
            <title>Mirvaso Gel</title>
            <description>Brimonidine Gel</description>
          </group>
        </group_list>
        <measure>
          <title>Facial Redness Visual Analog Scale (VAS)</title>
          <description>The number and percent of subjects in each transformed response category for the in-office subject reported facial redness VAS</description>
          <population>ITT Population, Subjects who received at least 1 application of study drug, and completed at least 1 assessment</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="181"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Very Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="57"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Very Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Very Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Very Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Inflammatory Lesions</title>
        <description>Change from baseline in facial inflammatory lesion count</description>
        <time_frame>14 days (Day 1 (Baseline) and Day 14/Exit)</time_frame>
        <population>ITT Population, Subjects who received at least 1 application of study drug, and completed at least 1 assessment</population>
        <group_list>
          <group group_id="O1">
            <title>Mirvaso Gel</title>
            <description>Brimonidine Gel</description>
          </group>
        </group_list>
        <measure>
          <title>Inflammatory Lesions</title>
          <description>Change from baseline in facial inflammatory lesion count</description>
          <population>ITT Population, Subjects who received at least 1 application of study drug, and completed at least 1 assessment</population>
          <units>lesions</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="181"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1: Lesions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".6" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14: Lesions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" spread="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14: Change From Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" spread="3.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>29 Days</time_frame>
      <desc>Adverse events were recorded for at least 14 days prior to the first treatment application.</desc>
      <group_list>
        <group group_id="E1">
          <title>Mirvaso Gel</title>
          <description>Brimonidine Gel</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA version 14.1</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="3" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>MedDRA version 14.1</default_vocab>
        <default_assessment>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="68" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>condition aggravated</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>feeling hot</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>rosacea</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="181"/>
              </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>The only 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Open label, single arm, short duration.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Jean Philippe York</name_or_title>
      <organization>Galderma Laboratories L.P.</organization>
      <phone>817-961-5468</phone>
      <email>jp.york@galderma.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/NCT02249065
org study id: GLI.04.SPR.US 10305
nct id: NCT02249065
lead sponsor: 
has dmc: No
This study is designed to:

        1. assess the signs and symptoms of rosacea, including erythema, without treatment and
           during treatment with Mirvaso® gel

        2. further characterize lifestyle impact and patient satisfaction with Mirvaso® treatment

        3. gain a better understanding of the real-world use of Mirvaso® on the pattern and
           management of facial erythema of rosacea.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pre-Treatment Clinician Erythema Assessment (CEA)
time frame: 14 days (Day 1 (Baseline), Day 7, and Day 14/Exit)
description: The number and percent of subjects in each CEA score category at each visit. CEA was conducted at the screening/baseline visit and all subsequent visits prior to the study drug application.
measure: Subject Facial Redness Questionnaire
time frame: 14 days (Day 1 (Baseline) and Day 14/Exit)
description: Facial Redness Questionnaire at Day 1 and Day 14 (Mean Number of Subjects Who's Responses Indicate They Were/Were Not Bothered By Facial Redness, Across All 11 Facial Redness Questions)
measure: Subject Treatment Satisfaction Questionnaire
time frame: 14 days (Day 14/Exit)
description: Mean Subject Treatment Satisfaction at Day 14 (Average Response Across 12 Questions)
measure: Facial Redness Visual Analog Scale (VAS)
time frame: 14 days (Day 1 (Baseline), Day 14/Exit)
description: The number and percent of subjects in each transformed response category for the in-office subject reported facial redness VAS
measure: Inflammatory Lesions
time frame: 14 days (Day 1 (Baseline) and Day 14/Exit)
description: Change from baseline in facial inflammatory lesion count
arm group label: Mirvaso Gel
arm group type: Experimental
description: Brimonidine topical gel, 0.33%
intervention type: Drug
intervention name: Brimonidine
arm group label: Mirvaso Gel
other name: Mirvaso Gel
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jeffrey Sugarman, MD
role: Principal Investigator
affiliation: Redwood Dermatology Center
facility: 
facility: 
facility: 
facility: 
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facility: 
country: United States
responsible party type: Sponsor
mesh term: Rosacea
mesh term: Brimonidine Tartrate
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Open label, single arm, short duration.
point of contact: 