<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/NCT02193815</url>
  </required_header>
  <id_info>
    <org_study_id>B5391003</org_study_id>
    <secondary_id>2014-000068-16</secondary_id>
    <nct_id>NCT02193815</nct_id>
  </id_info>
  <brief_title>A 12 Day Study To Evaluate A Topical Drug To Treat Plaque Psoriasis</brief_title>
  <official_title>A Phase 1, Single- Center, Randomized, Double-blind, Vehicle And Active Comparator-controlled Trial To Evaluate The Antipsoriatic Activity And Safety Of A Topically Applied Pf-06263276 Formulation In A Psoriasis Plaque Test</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>
      This is a vehicle and comparator controlled Proof of Mechanism (PoM) trial to evaluate the&#xD;
      effect on psoriasis disease activity and safety of topically applied PF 06263276 in subjects&#xD;
      with psoriasis vulgaris.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Psoriatic Skin Thickness/Echo-Poor Band (EPB) for PF-06263276 4% Solution in Comparison to Corresponding Vehicle at Day 12</measure>
    <time_frame>Day 1 (Baseline), Day 12</time_frame>
    <description>Psoriatic skin thickness was measured using a 20 megahertz (MHz) high frequency sonograph. Serial A-scans were composed and presented on a monitor as a section of the skin.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Psoriatic Skin Thickness/EPB for PF-06263276 4% Solution in Comparison to Daivonex Solution at Day 12</measure>
    <time_frame>Day 1 (Baseline), Day 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Psoriatic Skin Thickness/EPB for Tofacitinib 2% Ointment in Comparison to Corresponding Vehicle at Day 12</measure>
    <time_frame>Day 1 (Baseline), Day 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Psoriatic Skin Thickness/EPB at Day 8</measure>
    <time_frame>Day 1 (Baseline), Day 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve (AUC) of Psoriatic Skin Thickness/EPB</measure>
    <time_frame>Day 1 (baseline) up to Day 12</time_frame>
    <description>The AUC of psoriatic skin thickness/EPB from Day 1 to Day 12 was determined using the linear trapezoidal rule. The mean raw values are reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Clinical Assessment at Day 1, 8 and 12</measure>
    <time_frame>Day 1, Day 8, Day 12</time_frame>
    <description>Global Clinical Assessment of the test fields was performed by visual examination using a 5-point score (-1=worsened; 0=unchanged [no effect]; 1=slight improvement; 2=clear improvement but not completely healed; 3=completely healed). Clinically apparent differences in erythema and infiltration will contribute to this global assessment. At baseline (Day 1), the score was documented as &quot;0&quot; (unchanged).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Specified Skin AEs</measure>
    <time_frame>Baseline up to 28 days after last study drug administration (Day 21)</time_frame>
    <description>An AE was any untoward medical occurrence in a participant who received study drug. An 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 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs. The number of participants with specified skin AEs was reported.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern</measure>
    <time_frame>Baseline up to Day 12</time_frame>
    <description>The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, RBC morphology, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (e.g., urine human chorionic gonadotropin [hCG] for females of childbearing potential).</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Potentially Clinically Significant Vital Signs Findings</measure>
    <time_frame>Baseline up to Day 12</time_frame>
    <description>Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate &lt;40 or &gt;120 beats per minute (bpm), standing pulse rate &lt;40 or &gt;140 bpm; systolic blood pressure (SBP) &gt;=30 millimeters of mercury (mmHg) change from baseline in same posture or SBP &lt;90 mmHg, diastolic blood pressure (DBP) &gt;=20 mmHg change from baseline in same posture or DBP &lt;50 mmHg.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Psoriasis Vulgaris</condition>
  <arm_group>
    <arm_group_label>One Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study treatments 1-6 Study drug, vehicle, Tofacitinib, vehicle, Daivonex solution and ointment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF06263276</intervention_name>
    <description>4% PF 06263276 solution Daily dosage: approximately 8 mg PF 06263276 QD</description>
    <arm_group_label>One Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Vehicle</intervention_name>
    <description>Active ingredient-free vehicle to 4% solution</description>
    <arm_group_label>One Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>2%Tofacitinib Ointment</intervention_name>
    <description>Daily Dosage: approximately 4 mg tofacitinib</description>
    <arm_group_label>One Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Vehicle</intervention_name>
    <description>Active ingredient-free vehicle to 2% Ointment</description>
    <arm_group_label>One Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Daivonex</intervention_name>
    <description>Daivonex solution (50 ug/ml Calcipotriol) Daily Dosage of calcipotriol: approximately 0.01 mg</description>
    <arm_group_label>One Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Daivonex Ointment</intervention_name>
    <description>Daivonex ointment (50 ug/g Calcipotriol) Daily Dosage of calcipotriol: approximately 0.01 mg</description>
    <arm_group_label>One Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male and/or female subjects age 18 years and older, inclusive. Healthy is&#xD;
             defined as no clinically relevant abnormalities identified by a detailed medical&#xD;
             history, full physical examination, including blood pressure and pulse rate&#xD;
             measurement, 12 lead ECG or clinical laboratory tests.&#xD;
&#xD;
          -  Subjects with psoriasis vulgaris in a chronic stable phase and with a plaque area of&#xD;
             mild to moderate severity sufficient for six treatment fields located in up to three&#xD;
             plaque areas.&#xD;
&#xD;
          -  The target lesion(s) should be on the trunk or extremities (excluding palms/soles).&#xD;
             Psoriatic lesions on the knees or elbows are not to be used as a target lesion.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica,&#xD;
             psoriasis arthropathica and pustular psoriasis.&#xD;
&#xD;
          -  Treatment with any systemic medications which in the opinion of the investigator might&#xD;
             counter or influence the trial aim (including anti psoriasis medications, eg,&#xD;
             corticosteroids, cytostatics or retinoids) or medications which are known to provoke&#xD;
             or aggravate psoriasis (eg, beta blocker, anti malarial drugs, lithium) or&#xD;
             phototherapy/psoralen+UVA (PUVA) within 4 weeks preceding the treatment phase of the&#xD;
             trial and during the trial.&#xD;
&#xD;
          -  Treatment with any locally acting medications (including anti-psoriasis medications&#xD;
             like vitamin D analogues, dithranol) within 4 weeks of the treatment phase.&#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>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bioskin GmbH</name>
      <address>
        <city>Hamburg</city>
        <zip>20095</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B5391003&amp;StudyName=A%2012%20Day%20Study%20To%20Evaluate%20A%20Topical%20Drug%20To%20Treat%20Plaque%20Psoriasis</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <results_first_submitted>March 4, 2016</results_first_submitted>
  <results_first_submitted_qc>May 2, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">June 9, 2016</results_first_posted>
  <last_update_submitted>May 2, 2016</last_update_submitted>
  <last_update_submitted_qc>May 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 9, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>psoriasis</keyword>
  <keyword>plaque</keyword>
  <keyword>vulgaris</keyword>
  <keyword>phase 1</keyword>
  <keyword>randomized</keyword>
  <keyword>double-blind</keyword>
  <keyword>topical</keyword>
  <keyword>safety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcitriol</mesh_term>
    <mesh_term>Calcipotriene</mesh_term>
    <mesh_term>Tofacitinib</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>This trial enrolled participants with chronic plaque type psoriasis and with a treatment area sufficient for 6 treatment fields on 1 to 3 comparable plaques defined as having treatment fields with psoriatic skin thickness/Echo-Poor Band (EPB) of at least 200 micrometers.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>All Participants</title>
          <description>Participants received the following treatments topically to 6 selected treatment fields: 4% PF-06263276 and its corresponding vehicle, 2% tofacitinib and its corresponding vehicle, calcipotriol (Daivonex) solution, and Daivonex ointment. The fields were occluded and participants returned daily to the center for re-application during the 11-day treatment period.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The safety population included all enrolled participants who received at least 1 dose of investigational product.</population>
      <group_list>
        <group group_id="B1">
          <title>All Participants</title>
          <description>Participants received the following treatments topically to 6 selected treatment fields: 4% PF-06263276 and its corresponding vehicle, 2% tofacitinib and its corresponding vehicle, calcipotriol (Daivonex) solution, and Daivonex ointment. The fields were occluded and participants returned daily to the center for re-application during the 11-day treatment period.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="15"/>
          </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="50.4" spread="8.8"/>
                  </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="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Psoriatic Skin Thickness/Echo-Poor Band (EPB) for PF-06263276 4% Solution in Comparison to Corresponding Vehicle at Day 12</title>
        <description>Psoriatic skin thickness was measured using a 20 megahertz (MHz) high frequency sonograph. Serial A-scans were composed and presented on a monitor as a section of the skin.</description>
        <time_frame>Day 1 (Baseline), Day 12</time_frame>
        <population>The Intent-to-Treat (ITT) population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06263276 4% Solution</title>
            <description>All participants who received PF-06263276 4% solution topically once daily for 11 days.</description>
          </group>
          <group group_id="O2">
            <title>PF-06263276 Vehicle</title>
            <description>All participants who received PF-06263276 vehicle (active ingredient- free) topically once daily for 11 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Psoriatic Skin Thickness/Echo-Poor Band (EPB) for PF-06263276 4% Solution in Comparison to Corresponding Vehicle at Day 12</title>
          <description>Psoriatic skin thickness was measured using a 20 megahertz (MHz) high frequency sonograph. Serial A-scans were composed and presented on a monitor as a section of the skin.</description>
          <population>The Intent-to-Treat (ITT) population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.</population>
          <units>micrometers</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="358.9" spread="132.84" lower_limit="285" upper_limit="432"/>
                    <measurement group_id="O2" value="353.1" spread="121.03" lower_limit="286" upper_limit="420"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.7" spread="91.10" lower_limit="-33" upper_limit="68"/>
                    <measurement group_id="O2" value="32.9" spread="96.72" lower_limit="-21" upper_limit="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.3465</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Adjusted Mean Ratio</param_type>
            <param_value>93.20</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.075</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>80.43</ci_lower_limit>
            <ci_upper_limit>107.99</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Psoriatic Skin Thickness/EPB for PF-06263276 4% Solution in Comparison to Daivonex Solution at Day 12</title>
        <time_frame>Day 1 (Baseline), Day 12</time_frame>
        <population>The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06263276 4% Solution</title>
            <description>All participants who received PF-06263276 4% solution topically once daily for 11 days.</description>
          </group>
          <group group_id="O2">
            <title>Daivonex Solution</title>
            <description>All participants who received calcipotriol solution (50 micrograms per milliliter [mcg/mL]) topically once daily for 11 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Psoriatic Skin Thickness/EPB for PF-06263276 4% Solution in Comparison to Daivonex Solution at Day 12</title>
          <population>The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.</population>
          <units>micrometers</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.7" spread="91.10"/>
                    <measurement group_id="O2" value="-135.5" spread="114.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Adjusted Mean</param_type>
            <param_value>165.88</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.075</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>143.12</ci_lower_limit>
            <ci_upper_limit>192.25</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Psoriatic Skin Thickness/EPB for Tofacitinib 2% Ointment in Comparison to Corresponding Vehicle at Day 12</title>
        <time_frame>Day 1 (Baseline), Day 12</time_frame>
        <population>The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 2% Ointment</title>
            <description>All participants who received tofacitinib 2% ointment topically once daily for 11 days.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib Vehicle</title>
            <description>All participants who received tofacitinib vehicle (active ingredient-free) topically once daily for 11 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Psoriatic Skin Thickness/EPB for Tofacitinib 2% Ointment in Comparison to Corresponding Vehicle at Day 12</title>
          <population>The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.</population>
          <units>micrometers</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="364.1" spread="135.82"/>
                    <measurement group_id="O2" value="357.3" spread="135.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-117.8" spread="115.15"/>
                    <measurement group_id="O2" value="0.1" spread="95.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Adjusted Mean</param_type>
            <param_value>65.42</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.075</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>56.46</ci_lower_limit>
            <ci_upper_limit>75.81</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Psoriatic Skin Thickness/EPB at Day 8</title>
        <time_frame>Day 1 (Baseline), Day 8</time_frame>
        <population>The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06263276 4% Solution</title>
            <description>All participants who received PF-06263276 4% solution topically once daily for 11 days.</description>
          </group>
          <group group_id="O2">
            <title>PF-06263276 Vehicle</title>
            <description>All participants who received PF-06263276 vehicle (active ingredient-free) topically once daily for 11 days.</description>
          </group>
          <group group_id="O3">
            <title>Tofacitinib 2% Ointment</title>
            <description>All participants who received tofacitinib 2% ointment topically once daily for 11 days.</description>
          </group>
          <group group_id="O4">
            <title>Tofacitinib Vehicle</title>
            <description>All participants who received tofacitinib vehicle (active ingredient-free) topically once daily for 11 days.</description>
          </group>
          <group group_id="O5">
            <title>Daivonex Solution</title>
            <description>All participants who received calcipotriol solution (50 micrograms per milliliter [mcg/mL]) topically once daily for 11 days.</description>
          </group>
          <group group_id="O6">
            <title>Daivonex Ointment</title>
            <description>All participants who received calcipotriol ointment (50 micrograms per gram [mcg/g]) topically once daily for 11 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Psoriatic Skin Thickness/EPB at Day 8</title>
          <population>The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.</population>
          <units>micrometers</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="15"/>
                <count group_id="O6" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="358.9" spread="132.84"/>
                    <measurement group_id="O2" value="353.1" spread="121.03"/>
                    <measurement group_id="O3" value="364.1" spread="135.82"/>
                    <measurement group_id="O4" value="357.3" spread="135.60"/>
                    <measurement group_id="O5" value="376.1" spread="148.44"/>
                    <measurement group_id="O6" value="364.1" spread="124.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.0" spread="86.37"/>
                    <measurement group_id="O2" value="38.5" spread="65.45"/>
                    <measurement group_id="O3" value="-90.5" spread="84.11"/>
                    <measurement group_id="O4" value="15.1" spread="104.55"/>
                    <measurement group_id="O5" value="-98.8" spread="127.18"/>
                    <measurement group_id="O6" value="-104.7" spread="65.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.3349</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Adjusted Mean</param_type>
            <param_value>93.04</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.075</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>80.30</ci_lower_limit>
            <ci_upper_limit>107.81</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Adjusted Mean</param_type>
            <param_value>149.56</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.075</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>129.04</ci_lower_limit>
            <ci_upper_limit>173.34</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.3991</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Adjusted Mean</param_type>
            <param_value>106.51</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.075</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>91.92</ci_lower_limit>
            <ci_upper_limit>123.41</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Adjusted Mean</param_type>
            <param_value>71.94</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.075</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>62.08</ci_lower_limit>
            <ci_upper_limit>83.36</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Curve (AUC) of Psoriatic Skin Thickness/EPB</title>
        <description>The AUC of psoriatic skin thickness/EPB from Day 1 to Day 12 was determined using the linear trapezoidal rule. The mean raw values are reported.</description>
        <time_frame>Day 1 (baseline) up to Day 12</time_frame>
        <population>The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06263276 4% Solution</title>
            <description>All participants who received PF-06263276 4% solution topically once daily for 11 days.</description>
          </group>
          <group group_id="O2">
            <title>PF-06263276 Vehicle</title>
            <description>All participants who received PF-06263276 vehicle (active ingredient-free) topically once daily for 11 days.</description>
          </group>
          <group group_id="O3">
            <title>Tofacitinib 2% Ointment</title>
            <description>All participants who received tofacitinib 2% ointment topically once daily for 11 days.</description>
          </group>
          <group group_id="O4">
            <title>Tofacitinib Vehicle</title>
            <description>All participants who received tofacitinib vehicle (active ingredient-free) topically once daily for 11 days.</description>
          </group>
          <group group_id="O5">
            <title>Daivonex Solution</title>
            <description>All participants who received calcipotriol solution (50 micrograms per milliliter [mcg/mL]) topically once daily for 11 days.</description>
          </group>
          <group group_id="O6">
            <title>Daivonex Ointment</title>
            <description>All participants who received calcipotriol ointment (50 micrograms per gram [mcg/g]) topically once daily for 11 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Curve (AUC) of Psoriatic Skin Thickness/EPB</title>
          <description>The AUC of psoriatic skin thickness/EPB from Day 1 to Day 12 was determined using the linear trapezoidal rule. The mean raw values are reported.</description>
          <population>The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.</population>
          <units>micrometers*day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="15"/>
                <count group_id="O6" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4082.60" spread="1726.167"/>
                    <measurement group_id="O2" value="4161.40" spread="1436.733"/>
                    <measurement group_id="O3" value="3271.93" spread="1210.138"/>
                    <measurement group_id="O4" value="4013.07" spread="1465.339"/>
                    <measurement group_id="O5" value="3322.40" spread="1663.668"/>
                    <measurement group_id="O6" value="3165.47" spread="1113.937"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.7529</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Adjusted Mean</param_type>
            <param_value>96.04</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.127</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>74.00</ci_lower_limit>
            <ci_upper_limit>124.64</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.1318</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Adjusted Mean</param_type>
            <param_value>125.62</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.147</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>92.96</ci_lower_limit>
            <ci_upper_limit>169.75</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.8009</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Adjusted Mean</param_type>
            <param_value>103.35</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.129</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>79.30</ci_lower_limit>
            <ci_upper_limit>134.68</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.1012</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Adjusted Mean</param_type>
            <param_value>81.09</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.124</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>62.94</ci_lower_limit>
            <ci_upper_limit>104.47</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Global Clinical Assessment at Day 1, 8 and 12</title>
        <description>Global Clinical Assessment of the test fields was performed by visual examination using a 5-point score (-1=worsened; 0=unchanged [no effect]; 1=slight improvement; 2=clear improvement but not completely healed; 3=completely healed). Clinically apparent differences in erythema and infiltration will contribute to this global assessment. At baseline (Day 1), the score was documented as &quot;0&quot; (unchanged).</description>
        <time_frame>Day 1, Day 8, Day 12</time_frame>
        <population>The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06263276 4% Solution</title>
            <description>All participants who received PF-06263276 4% solution topically once daily for 11 days.</description>
          </group>
          <group group_id="O2">
            <title>PF-06263276 Vehicle</title>
            <description>All participants who received PF-06263276 vehicle (active ingredient-free) topically once daily for 11 days.</description>
          </group>
          <group group_id="O3">
            <title>Tofacitinib 2% Ointment</title>
            <description>All participants who received tofacitinib 2% ointment topically once daily for 11 days.</description>
          </group>
          <group group_id="O4">
            <title>Tofacitinib Vehicle</title>
            <description>All participants who received tofacitinib vehicle (active ingredient-free) topically once daily for 11 days.</description>
          </group>
          <group group_id="O5">
            <title>Daivonex Solution</title>
            <description>All participants who received calcipotriol solution (50 micrograms per milliliter [mcg/mL]) topically once daily for 11 days.</description>
          </group>
          <group group_id="O6">
            <title>Daivonex Ointment</title>
            <description>All participants who received calcipotriol ointment (50 micrograms per gram [mcg/g]) topically once daily for 11 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Global Clinical Assessment at Day 1, 8 and 12</title>
          <description>Global Clinical Assessment of the test fields was performed by visual examination using a 5-point score (-1=worsened; 0=unchanged [no effect]; 1=slight improvement; 2=clear improvement but not completely healed; 3=completely healed). Clinically apparent differences in erythema and infiltration will contribute to this global assessment. At baseline (Day 1), the score was documented as &quot;0&quot; (unchanged).</description>
          <population>The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="15"/>
                <count group_id="O6" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1: Score -1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: Score 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="15"/>
                    <measurement group_id="O4" value="15"/>
                    <measurement group_id="O5" value="15"/>
                    <measurement group_id="O6" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: Score 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: Score 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: Score 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8: Score -1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8: Score 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="14"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8: Score 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="9"/>
                    <measurement group_id="O6" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8: Score 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8: Score 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12: Score -1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12: Score 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="11"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12: Score 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="6"/>
                    <measurement group_id="O6" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12: Score 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="7"/>
                    <measurement group_id="O6" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12: Score 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Specified Skin AEs</title>
        <description>An AE was any untoward medical occurrence in a participant who received study drug. An 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 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs. The number of participants with specified skin AEs was reported.</description>
        <time_frame>Baseline up to 28 days after last study drug administration (Day 21)</time_frame>
        <population>The safety population included all enrolled participants who received at least 1 dose of investigational product.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06263276 4% Solution</title>
            <description>All participants who received PF-06263276 4% solution topically once daily for 11 days.</description>
          </group>
          <group group_id="O2">
            <title>PF-06263276 Vehicle</title>
            <description>All participants who received PF-06263276 vehicle (active ingredient-free) topically once daily for 11 days.</description>
          </group>
          <group group_id="O3">
            <title>Tofacitinib 2% Ointment</title>
            <description>All participants who received tofacitinib 2% ointment topically once daily for 11 days.</description>
          </group>
          <group group_id="O4">
            <title>Tofacitinib Vehicle</title>
            <description>All participants who received tofacitinib vehicle (active ingredient-free) topically once daily for 11 days.</description>
          </group>
          <group group_id="O5">
            <title>Daivonex Solution</title>
            <description>All participants who received calcipotriol solution (50 micrograms per milliliter [mcg/mL]) topically once daily for 11 days.</description>
          </group>
          <group group_id="O6">
            <title>Daivonex Ointment</title>
            <description>All participants who received calcipotriol ointment (50 micrograms per gram [mcg/g]) topically once daily for 11 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Specified Skin AEs</title>
          <description>An AE was any untoward medical occurrence in a participant who received study drug. An 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 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs. The number of participants with specified skin AEs was reported.</description>
          <population>The safety population included all enrolled participants who received at least 1 dose of investigational product.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="15"/>
                <count group_id="O6" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Specified Skin AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Specified Skin SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern</title>
        <description>The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, RBC morphology, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (e.g., urine human chorionic gonadotropin [hCG] for females of childbearing potential).</description>
        <time_frame>Baseline up to Day 12</time_frame>
        <population>The safety population included all enrolled participants who received at least 1 dose of investigational product.</population>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>Participants received the following treatments topically to 6 selected treatment fields: 4% PF-06263276 and its corresponding vehicle, 2% tofacitinib and its corresponding vehicle, calcipotriol (Daivonex) solution, and Daivonex ointment. The fields were occluded and participants returned daily to the center for re-application during the 11-day treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern</title>
          <description>The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, RBC morphology, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (e.g., urine human chorionic gonadotropin [hCG] for females of childbearing potential).</description>
          <population>The safety population included all enrolled participants who received at least 1 dose of investigational product.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Potentially Clinically Significant Vital Signs Findings</title>
        <description>Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate &lt;40 or &gt;120 beats per minute (bpm), standing pulse rate &lt;40 or &gt;140 bpm; systolic blood pressure (SBP) &gt;=30 millimeters of mercury (mmHg) change from baseline in same posture or SBP &lt;90 mmHg, diastolic blood pressure (DBP) &gt;=20 mmHg change from baseline in same posture or DBP &lt;50 mmHg.</description>
        <time_frame>Baseline up to Day 12</time_frame>
        <population>The safety population included all enrolled participants who received at least 1 dose of investigational product.</population>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>Participants received the following treatments topically to 6 selected treatment fields: 4% PF-06263276 and its corresponding vehicle, 2% tofacitinib and its corresponding vehicle, calcipotriol (Daivonex) solution, and Daivonex ointment. The fields were occluded and participants returned daily to the center for re-application during the 11-day treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Potentially Clinically Significant Vital Signs Findings</title>
          <description>Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate &lt;40 or &gt;120 beats per minute (bpm), standing pulse rate &lt;40 or &gt;140 bpm; systolic blood pressure (SBP) &gt;=30 millimeters of mercury (mmHg) change from baseline in same posture or SBP &lt;90 mmHg, diastolic blood pressure (DBP) &gt;=20 mmHg change from baseline in same posture or DBP &lt;50 mmHg.</description>
          <population>The safety population included all enrolled participants who received at least 1 dose of investigational product.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SBP &lt;90 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP &lt;50 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pulse Rate &lt;40 or &gt;120 bpm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maximum Increase from Baseline in SBP &gt;=30 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maximum Increase from Baseline in DBP &gt;=20 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline up to 28 days after last study drug administration (Day 21)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>All Participants</title>
          <description>Participants received the following treatments topically to 6 selected treatment fields: 4% PF-06263276 and its corresponding vehicle, 2% tofacitinib and its corresponding vehicle, calcipotriol (Daivonex) solution, and Daivonex ointment. The fields were occluded and participants returned daily to the center for re-application during the 11-day treatment period.</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="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 17.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Facial pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Blister</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </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>
    <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/NCT02193815
org study id: B5391003
secondary id: 2014-000068-16
nct id: NCT02193815
lead sponsor: 
has dmc: No
This is a vehicle and comparator controlled Proof of Mechanism (PoM) trial to evaluate the
      effect on psoriasis disease activity and safety of topically applied PF 06263276 in subjects
      with psoriasis vulgaris.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change From Baseline in Psoriatic Skin Thickness/Echo-Poor Band (EPB) for PF-06263276 4% Solution in Comparison to Corresponding Vehicle at Day 12
time frame: Day 1 (Baseline), Day 12
description: Psoriatic skin thickness was measured using a 20 megahertz (MHz) high frequency sonograph. Serial A-scans were composed and presented on a monitor as a section of the skin.
measure: Change From Baseline in Psoriatic Skin Thickness/EPB for PF-06263276 4% Solution in Comparison to Daivonex Solution at Day 12
time frame: Day 1 (Baseline), Day 12
measure: Change From Baseline in Psoriatic Skin Thickness/EPB for Tofacitinib 2% Ointment in Comparison to Corresponding Vehicle at Day 12
time frame: Day 1 (Baseline), Day 12
measure: Change From Baseline in Psoriatic Skin Thickness/EPB at Day 8
time frame: Day 1 (Baseline), Day 8
measure: Area Under the Curve (AUC) of Psoriatic Skin Thickness/EPB
time frame: Day 1 (baseline) up to Day 12
description: The AUC of psoriatic skin thickness/EPB from Day 1 to Day 12 was determined using the linear trapezoidal rule. The mean raw values are reported.
measure: Global Clinical Assessment at Day 1, 8 and 12
time frame: Day 1, Day 8, Day 12
description: Global Clinical Assessment of the test fields was performed by visual examination using a 5-point score (-1=worsened; 0=unchanged [no effect]; 1=slight improvement; 2=clear improvement but not completely healed; 3=completely healed). Clinically apparent differences in erythema and infiltration will contribute to this global assessment. At baseline (Day 1), the score was documented as "0" (unchanged).
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Specified Skin AEs
time frame: Baseline up to 28 days after last study drug administration (Day 21)
description: An AE was any untoward medical occurrence in a participant who received study drug. An 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 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs. The number of participants with specified skin AEs was reported.
measure: Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern
time frame: Baseline up to Day 12
description: The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, RBC morphology, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (e.g., urine human chorionic gonadotropin [hCG] for females of childbearing potential).
measure: Number of Participants With Potentially Clinically Significant Vital Signs Findings
time frame: Baseline up to Day 12
description: Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate <40 or >120 beats per minute (bpm), standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) >=30 millimeters of mercury (mmHg) change from baseline in same posture or SBP <90 mmHg, diastolic blood pressure (DBP) >=20 mmHg change from baseline in same posture or DBP <50 mmHg.
arm group label: One Arm
arm group type: Experimental
description: Study treatments 1-6 Study drug, vehicle, Tofacitinib, vehicle, Daivonex solution and ointment
intervention type: Drug
intervention name: PF06263276
description: 4% PF 06263276 solution Daily dosage: approximately 8 mg PF 06263276 QD
arm group label: One Arm
intervention type: Other
intervention name: Vehicle
description: Active ingredient-free vehicle to 4% solution
arm group label: One Arm
intervention type: Drug
intervention name: 2%Tofacitinib Ointment
description: Daily Dosage: approximately 4 mg tofacitinib
arm group label: One Arm
intervention type: Other
intervention name: Vehicle
description: Active ingredient-free vehicle to 2% Ointment
arm group label: One Arm
intervention type: Drug
intervention name: Daivonex
description: Daivonex solution (50 ug/ml Calcipotriol) Daily Dosage of calcipotriol: approximately 0.01 mg
arm group label: One Arm
intervention type: Drug
intervention name: Daivonex Ointment
description: Daivonex ointment (50 ug/g Calcipotriol) Daily Dosage of calcipotriol: approximately 0.01 mg
arm group label: One Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
facility: 
country: Germany
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B5391003&StudyName=A%2012%20Day%20Study%20To%20Evaluate%20A%20Topical%20Drug%20To%20Treat%20Plaque%20Psoriasis
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Psoriasis
mesh term: Calcitriol
mesh term: Calcipotriene
mesh term: Tofacitinib
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 