<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/NCT01700985</url>
  </required_header>
  <id_info>
    <org_study_id>122-0551-203</org_study_id>
    <nct_id>NCT01700985</nct_id>
  </id_info>
  <brief_title>A Study to Determine the Efficacy and Safety of 122-0551 in Subjects With Plaque Psoriasis</brief_title>
  <official_title>A Double-Blind, Randomized, Single Center, Vehicle-Controlled, Parallel Group Study to Determine the Efficacy and Safety of 122-0551 in Subjects With Plaque Psoriasis Receiving Two Weeks of Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Corticosteroids are one of the mainstays of treatment for subjects with&#xD;
      corticosteroid-responsive dermatoses such as psoriasis. This study has been designed to&#xD;
      determine and compare the efficacy and safety of a formulation of 122-0551 versus the&#xD;
      corresponding Vehicle in subjects with stable plaque psoriasis after twice daily dosing for&#xD;
      14 consecutive days.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">September 2012</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Overall Disease Severity (ODS) Score</measure>
    <time_frame>baseline and Day 15 (End of Study - EOS)</time_frame>
    <description>The percentage of subjects with ODS &quot;treatment success&quot; at EOS where EOS is the subject's last completed visit. &quot;Treatment success&quot; is defined as an ODS of 0 or 1. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ODS &quot;Treatment Success&quot; at Day 8 and Day 15</measure>
    <time_frame>baseline, Day 8, and Day 15</time_frame>
    <description>The percentage of subjects with ODS &quot;treatment success&quot; at Day 8 and Day 15. &quot;Treatment success&quot; is defined as an ODS of 0 or 1. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ODS &quot;Improved&quot; at Day 8 and Day 15</measure>
    <time_frame>baseline, Day 8, and Day 15</time_frame>
    <description>The percentage of subjects rated &quot;improved&quot; with respect to ODS at Days 8 and 15. &quot;Improved&quot; is defined as at least a 2 grade decrease in ODS score relative to baseline. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>&quot;Treatment Success&quot; for Clinical Signs and Symptoms of Psoriasis</measure>
    <time_frame>baseline, Day 8 and Day 15</time_frame>
    <description>The percentage of subjects rated &quot;treatment success&quot; for each of the clinical signs and symptoms of psoriasis (scaling, erythema, plaque elevation) at Days 8 and 15. &quot;Treatment success&quot; is defined as a score of 0 or 1 based on a 5-point ordinal scale where 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>&quot;Improved&quot; for Clinical Signs and Symptoms of Psoriasis</measure>
    <time_frame>baseline, Day 8 and Day 15</time_frame>
    <description>The percentage of subjects rated &quot;improved&quot; for each of the clinical signs and symptoms of psoriasis (scaling, erythema, plaque elevation, pruritus) at Days 8 and 15. &quot;Improved&quot; is defined as at least a 2 grade decrease in score based on a 5-point ordinal scale where 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in % Body Surface Area (BSA) With Psoriasis</measure>
    <time_frame>baseline, Day 8 and Day 15</time_frame>
    <description>Changes in % BSA with active psoriasis in the Treatment Area at Days 8 and 15.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Psoriasis</condition>
  <condition>Plaque Psoriasis</condition>
  <arm_group>
    <arm_group_label>122-0551</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>122-0551</intervention_name>
    <description>Applied twice daily for two weeks</description>
    <arm_group_label>122-0551</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vehicle</intervention_name>
    <description>Applied twice daily for two weeks</description>
    <arm_group_label>Vehicle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject has a clinical diagnosis of stable plaque psoriasis&#xD;
&#xD;
          -  Subject has an ODS score for the Treatment Area of 3 or 4 at study start&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.&#xD;
&#xD;
          -  Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis.&#xD;
&#xD;
          -  Subject has used any phototherapy, photo-chemotherapy or systemic corticosteroid&#xD;
             therapy within 30 days prior to study start&#xD;
&#xD;
          -  Subject has used any systemic methotrexate, retinoids, cyclosporine or analogous&#xD;
             products within 90 days prior to study start&#xD;
&#xD;
          -  Subject has used any systemic biologic therapy for the treatment of psoriasis within 5&#xD;
             half-lives of the biologic prior to study start&#xD;
&#xD;
          -  Subject had prolonged exposure to natural or artificial sources of ultraviolet&#xD;
             radiation within 30 days prior to study start&#xD;
&#xD;
          -  Subject has used topical body (excluding the scalp) psoriasis therapy including coal&#xD;
             tar, anthralin, steroids, retinoids, vitamin D analogs (e.g., Dovonex®) within 14 days&#xD;
             prior to study start&#xD;
&#xD;
          -  Subject has used emollients/moisturizers on areas to be treated within four hours&#xD;
             prior to clinical evaluation at study start&#xD;
&#xD;
          -  Subject is currently using lithium or Plaquenil (hydroxychloroquine)&#xD;
&#xD;
          -  Subject is currently using a beta-blocking medication (e.g., propranolol) or ACE&#xD;
             (e.g., lisinopril) inhibitor at a dose that has not been stabilized&#xD;
&#xD;
          -  Subject is pregnant, lactating, or is planning to become pregnant during the study&#xD;
&#xD;
          -  Subject is currently enrolled in an investigational drug or device study&#xD;
&#xD;
          -  Subject has used an investigational drug or investigational device treatment within 30&#xD;
             days prior to study start&#xD;
&#xD;
          -  Subject has been previously enrolled in this study and treated with a test article&#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>Syd Dromgoole, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Therapeutics, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Therapeutics Clinical Research</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DermResearch, Inc.</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78759</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <results_first_submitted>August 30, 2018</results_first_submitted>
  <results_first_submitted_qc>September 28, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">October 25, 2018</results_first_posted>
  <disposition_first_submitted>November 25, 2013</disposition_first_submitted>
  <disposition_first_submitted_qc>November 25, 2013</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">December 19, 2013</disposition_first_posted>
  <last_update_submitted>September 28, 2018</last_update_submitted>
  <last_update_submitted_qc>September 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>psoriasis</keyword>
  <keyword>plaque psoriasis</keyword>
  <keyword>122-0551</keyword>
  <keyword>steroid</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment period: May 2012 to September 2012&#xD;
The location of clinical sites included dermatology clinical research centers.</recruitment_details>
      <pre_assignment_details>All subjects who met the entry criteria were randomized and enrolled into the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>122-0551</title>
          <description>122-0551: Applied twice daily for two weeks</description>
        </group>
        <group group_id="P2">
          <title>Vehicle</title>
          <description>Vehicle: Applied twice daily for two weeks</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Incarcerated</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline analyses are based on the Safety population. All participants enrolled in the study who were dispensed and applied test article at least once.</population>
      <group_list>
        <group group_id="B1">
          <title>122-0551</title>
          <description>122-0551: Applied twice daily for two weeks</description>
        </group>
        <group group_id="B2">
          <title>Vehicle</title>
          <description>Vehicle: Applied twice daily for two weeks</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="23"/>
            <count group_id="B2" value="21"/>
            <count group_id="B3" value="44"/>
          </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="51.3" spread="14.3"/>
                    <measurement group_id="B2" value="48.6" spread="14.9"/>
                    <measurement group_id="B3" value="50.0" spread="14.5"/>
                  </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="4"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</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>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</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>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>
                  <title>Unknown or Not Reported</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>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Overall Disease Severity (ODS) Score</title>
        <description>The percentage of subjects with ODS &quot;treatment success&quot; at EOS where EOS is the subject's last completed visit. &quot;Treatment success&quot; is defined as an ODS of 0 or 1. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe.</description>
        <time_frame>baseline and Day 15 (End of Study - EOS)</time_frame>
        <population>Analysis shown is the Intent-to-treat (ITT) population, defined as all participants who were randomized, applied at least one dose, and had at least one follow-up visit after the Baseline visit. One study participant (VEH group) did not return to the clinic (incarcerated) following Visit 1 (baseline visit) and was excluded from the ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>122-0551</title>
            <description>122-0551: Applied twice daily for two weeks</description>
          </group>
          <group group_id="O2">
            <title>Vehicle</title>
            <description>Vehicle: Applied twice daily for two weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Overall Disease Severity (ODS) Score</title>
          <description>The percentage of subjects with ODS &quot;treatment success&quot; at EOS where EOS is the subject's last completed visit. &quot;Treatment success&quot; is defined as an ODS of 0 or 1. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe.</description>
          <population>Analysis shown is the Intent-to-treat (ITT) population, defined as all participants who were randomized, applied at least one dose, and had at least one follow-up visit after the Baseline visit. One study participant (VEH group) did not return to the clinic (incarcerated) following Visit 1 (baseline visit) and was excluded from the ITT population.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.2"/>
                    <measurement group_id="O2" value="0.0"/>
                  </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</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ODS &quot;Treatment Success&quot; at Day 8 and Day 15</title>
        <description>The percentage of subjects with ODS &quot;treatment success&quot; at Day 8 and Day 15. &quot;Treatment success&quot; is defined as an ODS of 0 or 1. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe.</description>
        <time_frame>baseline, Day 8, and Day 15</time_frame>
        <population>Analysis shown is the Intent-to-treat (ITT) population.</population>
        <group_list>
          <group group_id="O1">
            <title>122-0551</title>
            <description>122-0551: Applied twice daily for two weeks</description>
          </group>
          <group group_id="O2">
            <title>Vehicle</title>
            <description>Vehicle: Applied twice daily for two weeks</description>
          </group>
        </group_list>
        <measure>
          <title>ODS &quot;Treatment Success&quot; at Day 8 and Day 15</title>
          <description>The percentage of subjects with ODS &quot;treatment success&quot; at Day 8 and Day 15. &quot;Treatment success&quot; is defined as an ODS of 0 or 1. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe.</description>
          <population>Analysis shown is the Intent-to-treat (ITT) population.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.2"/>
                    <measurement group_id="O2" value="0.0"/>
                  </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</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>At Day 15.</p_value_desc>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ODS &quot;Improved&quot; at Day 8 and Day 15</title>
        <description>The percentage of subjects rated &quot;improved&quot; with respect to ODS at Days 8 and 15. &quot;Improved&quot; is defined as at least a 2 grade decrease in ODS score relative to baseline. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe.</description>
        <time_frame>baseline, Day 8, and Day 15</time_frame>
        <population>Analysis shown is the Intent-to-treat (ITT) population.</population>
        <group_list>
          <group group_id="O1">
            <title>122-0551</title>
            <description>122-0551: Applied twice daily for two weeks</description>
          </group>
          <group group_id="O2">
            <title>Vehicle</title>
            <description>Vehicle: Applied twice daily for two weeks</description>
          </group>
        </group_list>
        <measure>
          <title>ODS &quot;Improved&quot; at Day 8 and Day 15</title>
          <description>The percentage of subjects rated &quot;improved&quot; with respect to ODS at Days 8 and 15. &quot;Improved&quot; is defined as at least a 2 grade decrease in ODS score relative to baseline. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe.</description>
          <population>Analysis shown is the Intent-to-treat (ITT) population.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.2"/>
                    <measurement group_id="O2" value="0.0"/>
                  </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</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>At Day 15.</p_value_desc>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>&quot;Treatment Success&quot; for Clinical Signs and Symptoms of Psoriasis</title>
        <description>The percentage of subjects rated &quot;treatment success&quot; for each of the clinical signs and symptoms of psoriasis (scaling, erythema, plaque elevation) at Days 8 and 15. &quot;Treatment success&quot; is defined as a score of 0 or 1 based on a 5-point ordinal scale where 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe.</description>
        <time_frame>baseline, Day 8 and Day 15</time_frame>
        <population>Analysis shown is the Intent-to-treat (ITT) population.</population>
        <group_list>
          <group group_id="O1">
            <title>122-0551</title>
            <description>122-0551: Applied twice daily for two weeks</description>
          </group>
          <group group_id="O2">
            <title>Vehicle</title>
            <description>Vehicle: Applied twice daily for two weeks</description>
          </group>
        </group_list>
        <measure>
          <title>&quot;Treatment Success&quot; for Clinical Signs and Symptoms of Psoriasis</title>
          <description>The percentage of subjects rated &quot;treatment success&quot; for each of the clinical signs and symptoms of psoriasis (scaling, erythema, plaque elevation) at Days 8 and 15. &quot;Treatment success&quot; is defined as a score of 0 or 1 based on a 5-point ordinal scale where 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe.</description>
          <population>Analysis shown is the Intent-to-treat (ITT) population.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Scaling (Day 8)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.7"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Scaling (Day 15)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.9"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema (Day 8)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema (Day 15)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.7"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Plaque Elevation (Day 8)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.7"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Plaque Elevation (Day 15)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.5"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>&quot;Improved&quot; for Clinical Signs and Symptoms of Psoriasis</title>
        <description>The percentage of subjects rated &quot;improved&quot; for each of the clinical signs and symptoms of psoriasis (scaling, erythema, plaque elevation, pruritus) at Days 8 and 15. &quot;Improved&quot; is defined as at least a 2 grade decrease in score based on a 5-point ordinal scale where 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe.</description>
        <time_frame>baseline, Day 8 and Day 15</time_frame>
        <population>Analysis shown is the Intent-to-treat (ITT) population.</population>
        <group_list>
          <group group_id="O1">
            <title>122-0551</title>
            <description>122-0551: Applied twice daily for two weeks</description>
          </group>
          <group group_id="O2">
            <title>Vehicle</title>
            <description>Vehicle: Applied twice daily for two weeks</description>
          </group>
        </group_list>
        <measure>
          <title>&quot;Improved&quot; for Clinical Signs and Symptoms of Psoriasis</title>
          <description>The percentage of subjects rated &quot;improved&quot; for each of the clinical signs and symptoms of psoriasis (scaling, erythema, plaque elevation, pruritus) at Days 8 and 15. &quot;Improved&quot; is defined as at least a 2 grade decrease in score based on a 5-point ordinal scale where 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe.</description>
          <population>Analysis shown is the Intent-to-treat (ITT) population.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Scaling (Day 8)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.1"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Scaling (Day 15)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.9"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema (Day 8)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema (Day 15)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.8"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Plaque Elevation (Day 8)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Plaque Elevation (Day 15)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.5"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in % Body Surface Area (BSA) With Psoriasis</title>
        <description>Changes in % BSA with active psoriasis in the Treatment Area at Days 8 and 15.</description>
        <time_frame>baseline, Day 8 and Day 15</time_frame>
        <population>Analysis shown is the Intent-to-treat (ITT) population. The mean percent BSA at baseline was 4.8 for the active group (122-0551) and 4.6 for the vehicle group.</population>
        <group_list>
          <group group_id="O1">
            <title>122-0551</title>
            <description>122-0551: Applied twice daily for two weeks</description>
          </group>
          <group group_id="O2">
            <title>Vehicle</title>
            <description>Vehicle: Applied twice daily for two weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change in % Body Surface Area (BSA) With Psoriasis</title>
          <description>Changes in % BSA with active psoriasis in the Treatment Area at Days 8 and 15.</description>
          <population>Analysis shown is the Intent-to-treat (ITT) population. The mean percent BSA at baseline was 4.8 for the active group (122-0551) and 4.6 for the vehicle group.</population>
          <units>Change in percent BSA</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="0.69"/>
                    <measurement group_id="O2" value="0.0" spread="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.3" spread="2.07"/>
                    <measurement group_id="O2" value="0.0" spread="0.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or early participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.</time_frame>
      <desc>The Safety population included all participants enrolled in the study who were dispensed and applied the test article at least once; all participants enrolled in the study applied the first application in the clinic and were included in the Safety population.</desc>
      <group_list>
        <group group_id="E1">
          <title>122-0551</title>
          <description>122-0551: Applied twice daily for two weeks</description>
        </group>
        <group group_id="E2">
          <title>Vehicle</title>
          <description>Vehicle: Applied twice daily for two weeks</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 15.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The Sponsor has first right to publish pooled study data. In the event that such manuscript has not been submitted for publication within 12 months from study completion/termination at all participating sites, the PI shall have the right to single center publications provided they submit any data for presentation, oral or written, to the Sponsor for review 30 days prior to public disclosure. The PI may not disclose previously undisclosed confidential information other than study results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Research, Therapeutics Inc.</name_or_title>
      <organization>Therapeutics Inc.</organization>
      <phone>858-571-1800</phone>
      <email>clinicalresearch@therapeuticsinc.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/NCT01700985
org study id: 122-0551-203
nct id: NCT01700985
lead sponsor: 
has dmc: No
Corticosteroids are one of the mainstays of treatment for subjects with
      corticosteroid-responsive dermatoses such as psoriasis. This study has been designed to
      determine and compare the efficacy and safety of a formulation of 122-0551 versus the
      corresponding Vehicle in subjects with stable plaque psoriasis after twice daily dosing for
      14 consecutive days.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change in Overall Disease Severity (ODS) Score
time frame: baseline and Day 15 (End of Study - EOS)
description: The percentage of subjects with ODS "treatment success" at EOS where EOS is the subject's last completed visit. "Treatment success" is defined as an ODS of 0 or 1. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe.
measure: ODS "Treatment Success" at Day 8 and Day 15
time frame: baseline, Day 8, and Day 15
description: The percentage of subjects with ODS "treatment success" at Day 8 and Day 15. "Treatment success" is defined as an ODS of 0 or 1. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe.
measure: ODS "Improved" at Day 8 and Day 15
time frame: baseline, Day 8, and Day 15
description: The percentage of subjects rated "improved" with respect to ODS at Days 8 and 15. "Improved" is defined as at least a 2 grade decrease in ODS score relative to baseline. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe.
measure: "Treatment Success" for Clinical Signs and Symptoms of Psoriasis
time frame: baseline, Day 8 and Day 15
description: The percentage of subjects rated "treatment success" for each of the clinical signs and symptoms of psoriasis (scaling, erythema, plaque elevation) at Days 8 and 15. "Treatment success" is defined as a score of 0 or 1 based on a 5-point ordinal scale where 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe.
measure: "Improved" for Clinical Signs and Symptoms of Psoriasis
time frame: baseline, Day 8 and Day 15
description: The percentage of subjects rated "improved" for each of the clinical signs and symptoms of psoriasis (scaling, erythema, plaque elevation, pruritus) at Days 8 and 15. "Improved" is defined as at least a 2 grade decrease in score based on a 5-point ordinal scale where 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe.
measure: Change in % Body Surface Area (BSA) With Psoriasis
time frame: baseline, Day 8 and Day 15
description: Changes in % BSA with active psoriasis in the Treatment Area at Days 8 and 15.
arm group label: 122-0551
arm group type: Experimental
arm group label: Vehicle
arm group type: Placebo Comparator
intervention type: Drug
intervention name: 122-0551
description: Applied twice daily for two weeks
arm group label: 122-0551
intervention type: Drug
intervention name: Vehicle
description: Applied twice daily for two weeks
arm group label: Vehicle
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Syd Dromgoole, PhD
role: Study Director
affiliation: Therapeutics, Inc.
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Psoriasis
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 