<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/NCT02205476</url>
  </required_header>
  <id_info>
    <org_study_id>B5301012</org_study_id>
    <secondary_id>2014-002703-17</secondary_id>
    <nct_id>NCT02205476</nct_id>
  </id_info>
  <brief_title>A Phase 2 Extension Study To Enroll Subjects Who Were Enrolled In B5301001 Study</brief_title>
  <official_title>A Long-term Efficacy Assessment Following Initial Scar Revision Surgery And Phase 2 Open-label Study To Evaluate Safety Of Re-treatment With Pf-06473871</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study is a multicenter, two-part, open-label phase II study in adults, evaluating the safety&#xD;
      and long-term efficacy of PF-06473871 one year after surgical revision and treatment with&#xD;
      PF-06473871.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    B5301001 study did not meet its predefined efficacy endpoints, the long term follow up study&#xD;
    B5301012 was terminated in 1/6/2015. No safety concerns identified.&#xD;
  </why_stopped>
  <start_date>December 2014</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit</measure>
    <time_frame>52 weeks after initial scar revision surgery in study B5301001</time_frame>
    <description>Physician scar assessment was performed using 10-point POSAS scale. Physician rated each of the items (vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion) for a scar on a score of 1 (normal skin) to 10 (worst scar imaginable).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part B: Number of Participants With Clinically Significant Vital Sign Abnormalities</measure>
    <time_frame>Part B: Baseline up to Week 15</time_frame>
    <description>Vital signs included pulse rate and systolic blood pressure and diastolic blood pressure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part B: Number of Participants With Clinical Laboratory Abnormalities</measure>
    <time_frame>Part B: Baseline up to Week 15</time_frame>
    <description>Clinical laboratory tests included clinical chemistry (sodium, potassium, chloride, bicarbonate, glucose, blood urea nitrogen (BUN), creatinine, albumin, calcium, total, direct and indirect bilirubin, gamma-glutamyltransferase (GGT), alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactic dehydrogenase (LDH), alkaline phosphatase, creatine phosphokinase (CPK), uric acid, amylase and lipase) and hematology (hemoglobin, hematocrit, red blood cell count (RBC), white blood cell count (WBC) with differential, and platelet count) tests to be performed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)</measure>
    <time_frame>Part B: Baseline up to Week 15</time_frame>
    <description>An Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit</measure>
    <time_frame>52 weeks after initial scar revision surgery in study B5301001</time_frame>
    <description>Patient global assessment was performed using the overall opinion question of the POSAS scale. Participants were asked to rate the severity of their scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (very different from normal skin).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptom and Appearance Domain Score at Part A Visit</measure>
    <time_frame>52 weeks after initial scar revision surgery in study B5301001</time_frame>
    <description>PR-SEQ questionnaire consisted of 30 different attributes of scars that included following four dimensions: appearance (5 attributes), symptoms (3 attributes), bothersomeness (8 attributes), and impacts on the quality of life (physical and emotional wellbeing [14 attributes]). Each question had 5 possible responses: not at all (0), slightly (1), moderately (2), very (3), and extremely (4). Subjects completed an abbreviated version which included only the Symptoms and Appearance dimensions to evaluate treatment outcomes. Each of the item scores were transformed into a 0 to 100 scale. Each dimension score was calculated from averaging the transformed scores (0 to 100 scaled) for specified items. Each domain score ranged from 0 to 100, with higher scores indicating higher severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physician and Participant Photoguide Scar Assessment Scale Score at Part A Visit</measure>
    <time_frame>52 weeks after initial scar revision surgery in study B5301001</time_frame>
    <description>Physician and participants rated severity of each scar using a photonumeric guide on a scale ranging from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Volumetric &amp; Colorimetric Scar Assessment (3D Imaging) at Part A Visit</measure>
    <time_frame>52 weeks after initial scar revision surgery in study B5301001</time_frame>
    <description>Three-dimension digital photography was planned to be taken of the participants scars for determination of scar volume, height, and color performed in a subset of selected investigational centers equipped with specialized 3D photographic equipment.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Hypertrophic Scars Resulting From Prior Breast Scar Revision Surgery</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The number of doses each subject receives will be consistent with number received in protocol B5301001 (Group 1 = 4 doses).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The number of doses each subject receives will be consistent with number received in protocol B5301001 (Group 2 = 3 doses).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06473871</intervention_name>
    <description>Subjects who previously were randomized in B5301001 study will go under a second revision surgery followed by 4 administration of PF-06473871.</description>
    <arm_group_label>Group 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06473871</intervention_name>
    <description>Subjects who previously were randomized in B5301001 study will go under a second revision surgery followed by 3 administration of PF-06473871.</description>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects previously randomized to Pfizer clinical study B5301001.&#xD;
&#xD;
          -  Subjects must be able to tolerate up to a 3 hour scar revision surgery under sedation&#xD;
             and local anesthesia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant female subject; breastfeeding female subjects; male subjects with partners&#xD;
             currently pregnant.&#xD;
&#xD;
          -  Any previous history of intolerable adverse reactions to PF-06473871, such as serious&#xD;
             adverse events attributed to study drug or having been withdrawn due to AE in&#xD;
             prerequisite study B5301001.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>57 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stephan Baker MD PA</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33146</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bayside Ambulatory Center</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33133</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kavali Plastic Surgery and Skin Renewal Center</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30328</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Primeter outpatient surgery center</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30328</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Body Aesthetic Research Center</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B5301012&amp;StudyName=A%20Phase%202%20Extension%20Study%20To%20Enroll%20Subjects%20Who%20Were%20Enrolled%20In%20B5301001%20Study</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <results_first_submitted>December 21, 2015</results_first_submitted>
  <results_first_submitted_qc>December 21, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 28, 2016</results_first_posted>
  <last_update_submitted>December 21, 2015</last_update_submitted>
  <last_update_submitted_qc>December 21, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Phase 2</keyword>
  <keyword>open-label</keyword>
  <keyword>safety</keyword>
  <keyword>hypertrophic scar revision surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertrophy</mesh_term>
    <mesh_term>Cicatrix, Hypertrophic</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants who received the treatment in previous study B5301001 (NCT01730339), were enrolled in this study.</recruitment_details>
      <pre_assignment_details>Participants who completed part A of the study had the option to obtain scar revision surgery with PF-06473871 in part B of the study. No participant entered into part B due to premature termination of the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Group 1: PF--06473871/Placebo (4* 5 mg/cm)</title>
          <description>Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 milligram per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.</description>
        </group>
        <group group_id="P2">
          <title>Group 2: PF--06473871/Placebo (3* 5 mg/cm)</title>
          <description>Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Study termination by Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Enrolled analysis set included all participants who signed an informed consent and for whom data were collected for Part A of this trial.</population>
      <group_list>
        <group group_id="B1">
          <title>Group 1: PF--06473871/Placebo (4* 5 mg/cm)</title>
          <description>Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 milligram per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.</description>
        </group>
        <group group_id="B2">
          <title>Group 2: PF--06473871/Placebo (3* 5 mg/cm)</title>
          <description>Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.</description>
        </group>
        <group group_id="B3">
          <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="7"/>
            <count group_id="B2" value="3"/>
            <count group_id="B3" value="10"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40.7" spread="6.80"/>
                    <measurement group_id="B2" value="39.0" spread="15.13"/>
                    <measurement group_id="B3" value="40.2" spread="9.08"/>
                  </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="7"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit</title>
        <description>Physician scar assessment was performed using 10-point POSAS scale. Physician rated each of the items (vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion) for a scar on a score of 1 (normal skin) to 10 (worst scar imaginable).</description>
        <time_frame>52 weeks after initial scar revision surgery in study B5301001</time_frame>
        <population>Enrolled analysis set included all participants who signed an informed consent and for whom data were collected for Part A of this trial.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: PF--06473871: 4* 5 mg/cm</title>
            <description>Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) and were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.</description>
          </group>
          <group group_id="O2">
            <title>Group 1: Placebo: 4* 5 mg/cm</title>
            <description>Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.</description>
          </group>
          <group group_id="O3">
            <title>Group 2: PF¬06473871: 3* 5 mg/cm</title>
            <description>Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.</description>
          </group>
          <group group_id="O4">
            <title>Group 2: Placebo: 3* 5 mg/cm</title>
            <description>Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast and 3 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.</description>
          </group>
        </group_list>
        <measure>
          <title>Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit</title>
          <description>Physician scar assessment was performed using 10-point POSAS scale. Physician rated each of the items (vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion) for a scar on a score of 1 (normal skin) to 10 (worst scar imaginable).</description>
          <population>Enrolled analysis set included all participants who signed an informed consent and for whom data were collected for Part A of this trial.</population>
          <units>units on scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Vascularity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.71" spread="1.496"/>
                    <measurement group_id="O2" value="2.71" spread="1.113"/>
                    <measurement group_id="O3" value="1.33" spread="0.577"/>
                    <measurement group_id="O4" value="2.00" spread="1.000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pigmentation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.79" spread="2.307"/>
                    <measurement group_id="O2" value="5.00" spread="2.517"/>
                    <measurement group_id="O3" value="2.00" spread="1.000"/>
                    <measurement group_id="O4" value="3.00" spread="2.000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Thickness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.86" spread="2.478"/>
                    <measurement group_id="O2" value="4.64" spread="2.286"/>
                    <measurement group_id="O3" value="2.00" spread="1.000"/>
                    <measurement group_id="O4" value="3.00" spread="2.000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Relief</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.14" spread="2.795"/>
                    <measurement group_id="O2" value="4.36" spread="2.358"/>
                    <measurement group_id="O3" value="2.00" spread="1.000"/>
                    <measurement group_id="O4" value="3.67" spread="3.055"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pliability</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.50" spread="2.693"/>
                    <measurement group_id="O2" value="3.93" spread="2.805"/>
                    <measurement group_id="O3" value="1.67" spread="0.577"/>
                    <measurement group_id="O4" value="3.67" spread="3.055"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Surface Area</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.86" spread="2.193"/>
                    <measurement group_id="O2" value="4.57" spread="2.573"/>
                    <measurement group_id="O3" value="2.33" spread="0.577"/>
                    <measurement group_id="O4" value="3.33" spread="2.517"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall opinion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.29" spread="2.628"/>
                    <measurement group_id="O2" value="4.64" spread="2.561"/>
                    <measurement group_id="O3" value="2.00" spread="1.000"/>
                    <measurement group_id="O4" value="3.00" spread="2.000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit</title>
        <description>Patient global assessment was performed using the overall opinion question of the POSAS scale. Participants were asked to rate the severity of their scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (very different from normal skin).</description>
        <time_frame>52 weeks after initial scar revision surgery in study B5301001</time_frame>
        <population>Enrolled analysis set included all participants who signed an informed consent and for whom data were collected for Part A of this trial.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: PF-06473871: 4* 5 mg/cm</title>
            <description>Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) and were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.</description>
          </group>
          <group group_id="O2">
            <title>Group 1: Placebo: 4* 5 mg/cm</title>
            <description>Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.</description>
          </group>
          <group group_id="O3">
            <title>Group 2: PF-06473871: 3* 5 mg/cm</title>
            <description>Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.</description>
          </group>
          <group group_id="O4">
            <title>Group 2: Placebo: 3* 5 mg/cm</title>
            <description>Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast and 3 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit</title>
          <description>Patient global assessment was performed using the overall opinion question of the POSAS scale. Participants were asked to rate the severity of their scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (very different from normal skin).</description>
          <population>Enrolled analysis set included all participants who signed an informed consent and for whom data were collected for Part A of this trial.</population>
          <units>units on scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.07" spread="2.281"/>
                    <measurement group_id="O2" value="6.57" spread="3.552"/>
                    <measurement group_id="O3" value="3.00" spread="1.732"/>
                    <measurement group_id="O4" value="4.00" spread="2.646"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptom and Appearance Domain Score at Part A Visit</title>
        <description>PR-SEQ questionnaire consisted of 30 different attributes of scars that included following four dimensions: appearance (5 attributes), symptoms (3 attributes), bothersomeness (8 attributes), and impacts on the quality of life (physical and emotional wellbeing [14 attributes]). Each question had 5 possible responses: not at all (0), slightly (1), moderately (2), very (3), and extremely (4). Subjects completed an abbreviated version which included only the Symptoms and Appearance dimensions to evaluate treatment outcomes. Each of the item scores were transformed into a 0 to 100 scale. Each dimension score was calculated from averaging the transformed scores (0 to 100 scaled) for specified items. Each domain score ranged from 0 to 100, with higher scores indicating higher severity.</description>
        <time_frame>52 weeks after initial scar revision surgery in study B5301001</time_frame>
        <population>Enrolled analysis set included all participants who signed an informed consent and for whom data were collected for Part A of this trial.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: PF-06473871: 4* 5 mg/cm</title>
            <description>Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) and were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.</description>
          </group>
          <group group_id="O2">
            <title>Group 1: Placebo: 4* 5 mg/cm</title>
            <description>Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.</description>
          </group>
          <group group_id="O3">
            <title>Group 2: PF¬06473871: 3* 5 mg/cm</title>
            <description>Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.</description>
          </group>
          <group group_id="O4">
            <title>Group 2: Placebo: 3* 5 mg/cm</title>
            <description>Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast and 3 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptom and Appearance Domain Score at Part A Visit</title>
          <description>PR-SEQ questionnaire consisted of 30 different attributes of scars that included following four dimensions: appearance (5 attributes), symptoms (3 attributes), bothersomeness (8 attributes), and impacts on the quality of life (physical and emotional wellbeing [14 attributes]). Each question had 5 possible responses: not at all (0), slightly (1), moderately (2), very (3), and extremely (4). Subjects completed an abbreviated version which included only the Symptoms and Appearance dimensions to evaluate treatment outcomes. Each of the item scores were transformed into a 0 to 100 scale. Each dimension score was calculated from averaging the transformed scores (0 to 100 scaled) for specified items. Each domain score ranged from 0 to 100, with higher scores indicating higher severity.</description>
          <population>Enrolled analysis set included all participants who signed an informed consent and for whom data were collected for Part A of this trial.</population>
          <units>units on scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Appearance</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.79" spread="28.965"/>
                    <measurement group_id="O2" value="49.29" spread="30.745"/>
                    <measurement group_id="O3" value="33.33" spread="12.583"/>
                    <measurement group_id="O4" value="48.33" spread="41.633"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Symptoms</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.21" spread="24.516"/>
                    <measurement group_id="O2" value="9.52" spread="16.962"/>
                    <measurement group_id="O3" value="0.00" spread="0.000"/>
                    <measurement group_id="O4" value="0.00" spread="0.000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Physician and Participant Photoguide Scar Assessment Scale Score at Part A Visit</title>
        <description>Physician and participants rated severity of each scar using a photonumeric guide on a scale ranging from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe).</description>
        <time_frame>52 weeks after initial scar revision surgery in study B5301001</time_frame>
        <population>Enrolled analysis set included all participants who signed an informed consent and for whom data were collected for Part A of this trial.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: PF-06473871: 4* 5 mg/cm</title>
            <description>Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) and were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.</description>
          </group>
          <group group_id="O2">
            <title>Group 1: Placebo: 4* 5 mg/cm</title>
            <description>Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.</description>
          </group>
          <group group_id="O3">
            <title>Group 2: PF¬06473871: 3* 5 mg/cm</title>
            <description>Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.</description>
          </group>
          <group group_id="O4">
            <title>Group 2: Placebo: 3* 5 mg/cm</title>
            <description>Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast and 3 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.</description>
          </group>
        </group_list>
        <measure>
          <title>Physician and Participant Photoguide Scar Assessment Scale Score at Part A Visit</title>
          <description>Physician and participants rated severity of each scar using a photonumeric guide on a scale ranging from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe).</description>
          <population>Enrolled analysis set included all participants who signed an informed consent and for whom data were collected for Part A of this trial.</population>
          <units>units on scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Physician assessment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.64" spread="1.600"/>
                    <measurement group_id="O2" value="3.00" spread="1.414"/>
                    <measurement group_id="O3" value="1.33" spread="0.577"/>
                    <measurement group_id="O4" value="2.33" spread="1.528"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participant assessment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.79" spread="1.577"/>
                    <measurement group_id="O2" value="3.14" spread="1.773"/>
                    <measurement group_id="O3" value="1.67" spread="0.577"/>
                    <measurement group_id="O4" value="2.67" spread="2.082"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part B: Number of Participants With Clinically Significant Vital Sign Abnormalities</title>
        <description>Vital signs included pulse rate and systolic blood pressure and diastolic blood pressure.</description>
        <time_frame>Part B: Baseline up to Week 15</time_frame>
        <population>Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: PF--06473871/Placebo: 4* 5 mg/cm</title>
            <description>Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery and were planned to receive scar revision surgery in part B of the study.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: PF--06473871/Placebo: 3* 5 mg/cm</title>
            <description>Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery and were planned to receive scar revision surgery in part B of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B: Number of Participants With Clinically Significant Vital Sign Abnormalities</title>
          <description>Vital signs included pulse rate and systolic blood pressure and diastolic blood pressure.</description>
          <population>Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part B: Number of Participants With Clinical Laboratory Abnormalities</title>
        <description>Clinical laboratory tests included clinical chemistry (sodium, potassium, chloride, bicarbonate, glucose, blood urea nitrogen (BUN), creatinine, albumin, calcium, total, direct and indirect bilirubin, gamma-glutamyltransferase (GGT), alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactic dehydrogenase (LDH), alkaline phosphatase, creatine phosphokinase (CPK), uric acid, amylase and lipase) and hematology (hemoglobin, hematocrit, red blood cell count (RBC), white blood cell count (WBC) with differential, and platelet count) tests to be performed.</description>
        <time_frame>Part B: Baseline up to Week 15</time_frame>
        <population>Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: PF--06473871/Placebo: 4* 5 mg/cm</title>
            <description>Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery and were planned to receive scar revision surgery in part B of the study.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: PF--06473871/Placebo: 3* 5 mg/cm</title>
            <description>Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery and were planned to receive scar revision surgery in part B of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B: Number of Participants With Clinical Laboratory Abnormalities</title>
          <description>Clinical laboratory tests included clinical chemistry (sodium, potassium, chloride, bicarbonate, glucose, blood urea nitrogen (BUN), creatinine, albumin, calcium, total, direct and indirect bilirubin, gamma-glutamyltransferase (GGT), alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactic dehydrogenase (LDH), alkaline phosphatase, creatine phosphokinase (CPK), uric acid, amylase and lipase) and hematology (hemoglobin, hematocrit, red blood cell count (RBC), white blood cell count (WBC) with differential, and platelet count) tests to be performed.</description>
          <population>Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)</title>
        <description>An Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A.</description>
        <time_frame>Part B: Baseline up to Week 15</time_frame>
        <population>Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: PF--06473871/Placebo: 4* 5 mg/cm</title>
            <description>Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery and were planned to receive scar revision surgery in part B of the study.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: PF--06473871/Placebo: 3* 5 mg/cm</title>
            <description>Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery and were planned to receive scar revision surgery in part B of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)</title>
          <description>An Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A.</description>
          <population>Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Volumetric &amp; Colorimetric Scar Assessment (3D Imaging) at Part A Visit</title>
        <description>Three-dimension digital photography was planned to be taken of the participants scars for determination of scar volume, height, and color performed in a subset of selected investigational centers equipped with specialized 3D photographic equipment.</description>
        <time_frame>52 weeks after initial scar revision surgery in study B5301001</time_frame>
        <population>The volumetric and colorimetric scar assessments were collected under this protocol but were not analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: PF--06473871: 4* 5 mg/cm</title>
            <description>Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) and were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.</description>
          </group>
          <group group_id="O2">
            <title>Group 1: Placebo: 4* 5 mg/cm</title>
            <description>Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.</description>
          </group>
          <group group_id="O3">
            <title>Group 2: PF¬06473871: 3* 5 mg/cm</title>
            <description>Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.</description>
          </group>
          <group group_id="O4">
            <title>Group 2: Placebo: 3* 5 mg/cm</title>
            <description>Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast and 3 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.</description>
          </group>
        </group_list>
        <measure>
          <title>Volumetric &amp; Colorimetric Scar Assessment (3D Imaging) at Part A Visit</title>
          <description>Three-dimension digital photography was planned to be taken of the participants scars for determination of scar volume, height, and color performed in a subset of selected investigational centers equipped with specialized 3D photographic equipment.</description>
          <population>The volumetric and colorimetric scar assessments were collected under this protocol but were not analyzed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>Adverse events were planned to be assessed in part B of the study. Part B of study was not initiated due to premature termination during part A of the study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Group 1: PF--06473871/Placebo (4* 5 mg/cm)</title>
          <description>Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 milligram per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.</description>
        </group>
        <group group_id="E2">
          <title>Group 2: PF--06473871/Placebo (3* 5 mg/cm)</title>
          <description>Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.</description>
        </group>
      </group_list>
      <serious_events>
        <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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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>Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The study was prematurely terminated at the discretion of sponsor as study B5301001 did not meet its pre-defined efficacy endpoints for the dosing regimens evaluated.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Pfizer ClinicalTrials.gov Call Center</name_or_title>
      <organization>Pfizer, Inc.</organization>
      <phone>1-800-718-1021</phone>
      <email>ClinicalTrials.gov_Inquiries@pfizer.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/NCT02205476
org study id: B5301012
secondary id: 2014-002703-17
nct id: NCT02205476
lead sponsor: 
has dmc: No
Study is a multicenter, two-part, open-label phase II study in adults, evaluating the safety
      and long-term efficacy of PF-06473871 one year after surgical revision and treatment with
      PF-06473871.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit
time frame: 52 weeks after initial scar revision surgery in study B5301001
description: Physician scar assessment was performed using 10-point POSAS scale. Physician rated each of the items (vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion) for a scar on a score of 1 (normal skin) to 10 (worst scar imaginable).
measure: Part B: Number of Participants With Clinically Significant Vital Sign Abnormalities
time frame: Part B: Baseline up to Week 15
description: Vital signs included pulse rate and systolic blood pressure and diastolic blood pressure.
measure: Part B: Number of Participants With Clinical Laboratory Abnormalities
time frame: Part B: Baseline up to Week 15
description: Clinical laboratory tests included clinical chemistry (sodium, potassium, chloride, bicarbonate, glucose, blood urea nitrogen (BUN), creatinine, albumin, calcium, total, direct and indirect bilirubin, gamma-glutamyltransferase (GGT), alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactic dehydrogenase (LDH), alkaline phosphatase, creatine phosphokinase (CPK), uric acid, amylase and lipase) and hematology (hemoglobin, hematocrit, red blood cell count (RBC), white blood cell count (WBC) with differential, and platelet count) tests to be performed.
measure: Part B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)
time frame: Part B: Baseline up to Week 15
description: An Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A.
measure: Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit
time frame: 52 weeks after initial scar revision surgery in study B5301001
description: Patient global assessment was performed using the overall opinion question of the POSAS scale. Participants were asked to rate the severity of their scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (very different from normal skin).
measure: Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptom and Appearance Domain Score at Part A Visit
time frame: 52 weeks after initial scar revision surgery in study B5301001
description: PR-SEQ questionnaire consisted of 30 different attributes of scars that included following four dimensions: appearance (5 attributes), symptoms (3 attributes), bothersomeness (8 attributes), and impacts on the quality of life (physical and emotional wellbeing [14 attributes]). Each question had 5 possible responses: not at all (0), slightly (1), moderately (2), very (3), and extremely (4). Subjects completed an abbreviated version which included only the Symptoms and Appearance dimensions to evaluate treatment outcomes. Each of the item scores were transformed into a 0 to 100 scale. Each dimension score was calculated from averaging the transformed scores (0 to 100 scaled) for specified items. Each domain score ranged from 0 to 100, with higher scores indicating higher severity.
measure: Physician and Participant Photoguide Scar Assessment Scale Score at Part A Visit
time frame: 52 weeks after initial scar revision surgery in study B5301001
description: Physician and participants rated severity of each scar using a photonumeric guide on a scale ranging from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe).
measure: Volumetric & Colorimetric Scar Assessment (3D Imaging) at Part A Visit
time frame: 52 weeks after initial scar revision surgery in study B5301001
description: Three-dimension digital photography was planned to be taken of the participants scars for determination of scar volume, height, and color performed in a subset of selected investigational centers equipped with specialized 3D photographic equipment.
arm group label: Group 1
arm group type: Experimental
description: The number of doses each subject receives will be consistent with number received in protocol B5301001 (Group 1 = 4 doses).
arm group label: Group 2
arm group type: Experimental
description: The number of doses each subject receives will be consistent with number received in protocol B5301001 (Group 2 = 3 doses).
intervention type: Drug
intervention name: PF-06473871
description: Subjects who previously were randomized in B5301001 study will go under a second revision surgery followed by 4 administration of PF-06473871.
arm group label: Group 1
intervention type: Drug
intervention name: PF-06473871
description: Subjects who previously were randomized in B5301001 study will go under a second revision surgery followed by 3 administration of PF-06473871.
arm group label: Group 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 57 Years
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B5301012&StudyName=A%20Phase%202%20Extension%20Study%20To%20Enroll%20Subjects%20Who%20Were%20Enrolled%20In%20B5301001%20Study
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Hypertrophy
mesh term: Cicatrix, Hypertrophic
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study was prematurely terminated at the discretion of sponsor as study B5301001 did not meet its pre-defined efficacy endpoints for the dosing regimens evaluated.
point of contact: 