<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/NCT03837743</url>
  </required_header>
  <id_info>
    <org_study_id>C928-015</org_study_id>
    <nct_id>NCT03837743</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy Study of DUR-928 Topical Solution in Subjects With Plaque Psoriasis</brief_title>
  <official_title>A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Proof of Concept Comparison Study of the Safety and Efficacy of DUR-928 Topical Solution With Occlusion in Subjects With Mild to Moderate Plaque Psoriasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Durect</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Durect</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This Phase 2 study has been designed to determine and compare the safety, tolerability, and&#xD;
      efficacy of DUR-928 topical solution with that of the vehicle topical solution when applied&#xD;
      once daily for approximately four weeks in subjects with plaque psoriasis. Subjects will be&#xD;
      instructed (randomly assigned) to apply DUR-928 solution to a target lesion on one arm and&#xD;
      vehicle solution to a target lesion on the opposite arm once daily for up to four weeks.&#xD;
      Subjects will occlude the treated areas for approximately two hours after each application.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 21, 2019</start_date>
  <completion_date type="Actual">May 20, 2020</completion_date>
  <primary_completion_date type="Actual">November 11, 2019</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Change From Baseline as Assessed on the Investigator's Global Assessment (IGA) Score.</measure>
    <time_frame>Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported)</time_frame>
    <description>The IGA of the Target Plaques will be determined on a 5-point scale. 0=Clear; 1=Almost Clear; 2=Mild; 3=Moderate; 4=Severe</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Change From Baseline as Assessed on the Clinical Signs of Psoriasis (Plaque Elevation, Scaling, and Erythema)</measure>
    <time_frame>Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported)</time_frame>
    <description>Each clinical sign (plaque elevation, scaling, erythema) will be graded on a 5-point scale.0=Clear; 1=Almost Clear; 2=Mild; 3=Moderate; 4=Severe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Change From Baseline as Assessed on the Local Psoriasis Severity Index (LPSI)</measure>
    <time_frame>Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported)</time_frame>
    <description>The LPSI is a sum of all three parameters (sum range of 0-12, with 12 being a worse outcome). Three parameters are plaque elevation, scaling, and erythema, each rated 0-4, 0=clear to 4=severe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Change From Baseline as Assessed by the Target Plaque Area.</measure>
    <time_frame>Up to Day 57 (assessed at Baseline, and Weeks 2,4,8, change from baseline to week 4 and 8 reported)</time_frame>
    <description>The surface areas of Target Plaque A (plaque on left arm) and Target Plaque B (plaque on right arm) will be measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Change From Baseline as Assessed on the Itch Numeric Rating Scale (I-NRS) for Pruritus.</measure>
    <time_frame>Up to Day 57 (assessed at Baseline, and Weeks 2,4,8, change from baseline to week 4 and 8 reported)</time_frame>
    <description>The I-NRS score is based on an 11-point scale where 0 represents &quot;no itching&quot; and 10 represents &quot;worst itch imaginable.&quot;</description>
  </secondary_outcome>
  <other_outcome>
    <measure>The Change From Baseline as Assessed on the Target Plaque Comparison</measure>
    <time_frame>Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported)</time_frame>
    <description>The Target Plaque Comparison is scored on a 3-point scale: 1A = Target Plaque A is better than Target Plaque B, 0 = Target Plaque A is the same as Target Plaque B, and 1B = Target Plaque A is worse than Target Plaque B.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Plaque Psoriasis</condition>
  <arm_group>
    <arm_group_label>DUR-928 Topical Solution</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DUR-928 Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle Topical Solution</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Vehicle Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DUR-928 Topical Solution</intervention_name>
    <description>Topical solution containing active drug</description>
    <arm_group_label>DUR-928 Topical Solution</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vehicle Topical Solution</intervention_name>
    <description>Topical solution containing no active drug</description>
    <arm_group_label>Vehicle Topical Solution</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is a male or non-pregnant female 18 years of age or older.&#xD;
&#xD;
          2. Subject has provided written informed consent.&#xD;
&#xD;
          3. Subject has a clinical diagnosis of stable mild to moderate plaque psoriasis for at&#xD;
             least two months.&#xD;
&#xD;
          4. Females must be post-menopausal, surgically sterile, or use an effective method of&#xD;
             birth control. Women of childbearing potential (WOCBP) must have a negative urine&#xD;
             pregnancy test (UPT) at Visit 2/Baseline.&#xD;
&#xD;
          5. Males (or their female partner) must agree to use an effective method of birth control&#xD;
             throughout the study.&#xD;
&#xD;
          6. Subject has two similar contralateral Target Plaques.&#xD;
&#xD;
          7. Subject is willing and able to apply the test article(s) as directed, comply with&#xD;
             study instructions, and commit to all follow-up visits for the duration of the study.&#xD;
&#xD;
          8. Subject, in the investigator's opinion, is in good general health and free of any&#xD;
             disease state or physical condition that might impair evaluation of the plaque&#xD;
             psoriasis or exposes the subject to an unacceptable risk by study participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject is pregnant, lactating, or is planning to become pregnant during the study.&#xD;
&#xD;
          2. Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.&#xD;
&#xD;
          3. Subject has guttate, pustular, erythrodermic, inverse, or other non-plaque forms of&#xD;
             psoriasis.&#xD;
&#xD;
          4. Subject has psoriasis beyond the two Target Plaques that, in the investigator's&#xD;
             opinion, could not be reasonably managed with only a bland emollient during the study.&#xD;
&#xD;
          5. Subject is currently enrolled in an investigational drug or device study.&#xD;
&#xD;
          6. Subject has been previously enrolled in this study and treated with test article.&#xD;
&#xD;
        Other protocol-defined inclusion and exclusion criteria assessed by the study staff may&#xD;
        apply.&#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>Tony Andrasfay</last_name>
    <role>Study Director</role>
    <affiliation>Therapeutics, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Site 01</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 04</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33162</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 05</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 02</name>
      <address>
        <city>Plainfield</city>
        <state>Indiana</state>
        <zip>46168</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 03</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>February 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <results_first_submitted>May 27, 2022</results_first_submitted>
  <results_first_submitted_qc>August 12, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">September 2, 2022</results_first_posted>
  <disposition_first_submitted>May 28, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>August 12, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">September 2, 2022</disposition_first_posted>
  <last_update_submitted>August 12, 2022</last_update_submitted>
  <last_update_submitted_qc>August 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pharmaceutical Solutions</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 22, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/43/NCT03837743/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This was a multi-site study conducted at five sites in the United States of America. Date first subject enrolled: March 20, 2019 and date last subject completed: November 7, 2019.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>DUR-928 Topical Solution and Vehicle Topical Solution</title>
          <description>DUR-928 Topical Solution and Vehicle Topical Solution separately applied topically once daily to one target lesion on an arm of a subject for approximately four weeks. Each arm of a subject containing one target lesion was allocated to a different intervention.&#xD;
DUR-928 Topical Solution: Topical solution containing active drug&#xD;
Vehicle Topical Solution: Topical solution containing no active drug</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>DUR-928 Topical Solution Lesion</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Vehicle Topical Solution Lesion</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety Population</population>
      <group_list>
        <group group_id="B1">
          <title>DUR-928 Topical Solution and Vehicle Topical Solution</title>
          <description>DUR-928 Topical Solution and Vehicle Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks.&#xD;
DUR-928 Topical Solution: Topical solution containing active drug Vehicle Topical Solution: Topical solution containing no active drug</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="25"/>
          </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="46.2" spread="11.32"/>
                  </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="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </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="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" 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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" 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="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Change From Baseline as Assessed on the Investigator's Global Assessment (IGA) Score.</title>
        <description>The IGA of the Target Plaques will be determined on a 5-point scale. 0=Clear; 1=Almost Clear; 2=Mild; 3=Moderate; 4=Severe</description>
        <time_frame>Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported)</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>DUR-928 Topical Solution</title>
            <description>DUR-928 Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks.&#xD;
DUR-928 Topical Solution: Topical solution containing active drug</description>
          </group>
          <group group_id="O2">
            <title>Vehicle Topical Solution</title>
            <description>Vehicle Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks.&#xD;
Vehicle Topical Solution: Topical solution containing no active drug</description>
          </group>
        </group_list>
        <measure>
          <title>The Change From Baseline as Assessed on the Investigator's Global Assessment (IGA) Score.</title>
          <description>The IGA of the Target Plaques will be determined on a 5-point scale. 0=Clear; 1=Almost Clear; 2=Mild; 3=Moderate; 4=Severe</description>
          <population>ITT Population</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4 (change from baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="0.83"/>
                    <measurement group_id="O2" value="-1.0" spread="0.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 (change from baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" spread="1.00"/>
                    <measurement group_id="O2" value="-0.8" spread="1.10"/>
                  </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>
            <groups_desc>Difference in Change (week 4)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.022</p_value>
            <method>Paired t-test</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.2</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.42</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Difference in Change (week 8)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.296</p_value>
            <method>Paired t-test</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.2</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.80</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Change From Baseline as Assessed on the Clinical Signs of Psoriasis (Plaque Elevation, Scaling, and Erythema)</title>
        <description>Each clinical sign (plaque elevation, scaling, erythema) will be graded on a 5-point scale.0=Clear; 1=Almost Clear; 2=Mild; 3=Moderate; 4=Severe.</description>
        <time_frame>Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DUR-928 Topical Solution</title>
            <description>DUR-928 Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks.&#xD;
DUR-928 Topical Solution: Topical solution containing active drug</description>
          </group>
          <group group_id="O2">
            <title>Vehicle Topical Solution</title>
            <description>Vehicle Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks.&#xD;
Vehicle Topical Solution: Topical solution containing no active drug</description>
          </group>
        </group_list>
        <measure>
          <title>The Change From Baseline as Assessed on the Clinical Signs of Psoriasis (Plaque Elevation, Scaling, and Erythema)</title>
          <description>Each clinical sign (plaque elevation, scaling, erythema) will be graded on a 5-point scale.0=Clear; 1=Almost Clear; 2=Mild; 3=Moderate; 4=Severe.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4 (Clinical Signs of Psoriasis - Plaque Elevation-Change from Baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0" spread="0.88"/>
                    <measurement group_id="O2" value="-1.2" spread="0.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 (Clinical Signs of Psoriasis - Plaque Elevation-Change from Baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" spread="0.98"/>
                    <measurement group_id="O2" value="-0.9" spread="1.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (Clinical Signs of Psoriasis - scaling-Change from Baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="0.89"/>
                    <measurement group_id="O2" value="-1.1" spread="1.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 (Clinical Signs of Psoriasis - scaling-Change from Baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" spread="0.95"/>
                    <measurement group_id="O2" value="-0.8" spread="1.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (Clinical Signs of Psoriasis - erythema-Change from Baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0" spread="0.88"/>
                    <measurement group_id="O2" value="-1.1" spread="1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 (Clinical Signs of Psoriasis - erythema-Change from Baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" spread="0.97"/>
                    <measurement group_id="O2" value="-1.1" spread="0.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Change From Baseline as Assessed on the Local Psoriasis Severity Index (LPSI)</title>
        <description>The LPSI is a sum of all three parameters (sum range of 0-12, with 12 being a worse outcome). Three parameters are plaque elevation, scaling, and erythema, each rated 0-4, 0=clear to 4=severe.</description>
        <time_frame>Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DUR-928 Topical Solution</title>
            <description>DUR-928 Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks.&#xD;
DUR-928 Topical Solution: Topical solution containing active drug</description>
          </group>
          <group group_id="O2">
            <title>Vehicle Topical Solution</title>
            <description>Vehicle Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks.&#xD;
Vehicle Topical Solution: Topical solution containing no active drug</description>
          </group>
        </group_list>
        <measure>
          <title>The Change From Baseline as Assessed on the Local Psoriasis Severity Index (LPSI)</title>
          <description>The LPSI is a sum of all three parameters (sum range of 0-12, with 12 being a worse outcome). Three parameters are plaque elevation, scaling, and erythema, each rated 0-4, 0=clear to 4=severe.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>week 4 (change from Baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.7" spread="2.40"/>
                    <measurement group_id="O2" value="-3.4" spread="2.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 8 (change from Baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.3" spread="2.69"/>
                    <measurement group_id="O2" value="-2.8" spread="3.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Change From Baseline as Assessed by the Target Plaque Area.</title>
        <description>The surface areas of Target Plaque A (plaque on left arm) and Target Plaque B (plaque on right arm) will be measured.</description>
        <time_frame>Up to Day 57 (assessed at Baseline, and Weeks 2,4,8, change from baseline to week 4 and 8 reported)</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>DUR-928 Topical Solution</title>
            <description>DUR-928 Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks.&#xD;
DUR-928 Topical Solution: Topical solution containing active drug</description>
          </group>
          <group group_id="O2">
            <title>Vehicle Topical Solution</title>
            <description>Vehicle Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks.&#xD;
Vehicle Topical Solution: Topical solution containing no active drug</description>
          </group>
        </group_list>
        <measure>
          <title>The Change From Baseline as Assessed by the Target Plaque Area.</title>
          <description>The surface areas of Target Plaque A (plaque on left arm) and Target Plaque B (plaque on right arm) will be measured.</description>
          <population>ITT population</population>
          <units>cm^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4 (change from Baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.5" spread="11.02"/>
                    <measurement group_id="O2" value="-7.4" spread="10.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 (change from Baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.8" spread="10.26"/>
                    <measurement group_id="O2" value="-8.3" spread="7.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Change From Baseline as Assessed on the Itch Numeric Rating Scale (I-NRS) for Pruritus.</title>
        <description>The I-NRS score is based on an 11-point scale where 0 represents &quot;no itching&quot; and 10 represents &quot;worst itch imaginable.&quot;</description>
        <time_frame>Up to Day 57 (assessed at Baseline, and Weeks 2,4,8, change from baseline to week 4 and 8 reported)</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>DUR-928 Topical Solution</title>
            <description>DUR-928 Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks.&#xD;
DUR-928 Topical Solution: Topical solution containing active drug</description>
          </group>
          <group group_id="O2">
            <title>Vehicle Topical Solution</title>
            <description>Vehicle Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks.&#xD;
Vehicle Topical Solution: Topical solution containing no active drug</description>
          </group>
        </group_list>
        <measure>
          <title>The Change From Baseline as Assessed on the Itch Numeric Rating Scale (I-NRS) for Pruritus.</title>
          <description>The I-NRS score is based on an 11-point scale where 0 represents &quot;no itching&quot; and 10 represents &quot;worst itch imaginable.&quot;</description>
          <population>ITT Population</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4 (change from baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.7" spread="2.19"/>
                    <measurement group_id="O2" value="-1.7" spread="1.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 (change from baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.6" spread="2.34"/>
                    <measurement group_id="O2" value="-1.5" spread="2.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>The Change From Baseline as Assessed on the Target Plaque Comparison</title>
        <description>The Target Plaque Comparison is scored on a 3-point scale: 1A = Target Plaque A is better than Target Plaque B, 0 = Target Plaque A is the same as Target Plaque B, and 1B = Target Plaque A is worse than Target Plaque B.</description>
        <time_frame>Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported)</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>DUR-928 Topical Solution and Vehicle Topical Solution</title>
            <description>DUR-928 Topical Solution and Vehicle Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks.&#xD;
DUR-928 Topical Solution: Topical solution containing active drug Vehicle Topical Solution: Topical solution containing no active drug</description>
          </group>
        </group_list>
        <measure>
          <title>The Change From Baseline as Assessed on the Target Plaque Comparison</title>
          <description>The Target Plaque Comparison is scored on a 3-point scale: 1A = Target Plaque A is better than Target Plaque B, 0 = Target Plaque A is the same as Target Plaque B, and 1B = Target Plaque A is worse than Target Plaque B.</description>
          <population>ITT Population</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4 : Active Better</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 : Same</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 : Active Worse</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 : Active Better</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 : Same</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 : Active Worse</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to Day 57</time_frame>
      <desc>Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.</desc>
      <group_list>
        <group group_id="E1">
          <title>DUR-928 Topical Solution and Vehicle Topical Solution, Safety Population</title>
          <description>DUR-928 Topical Solution and Vehicle Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks. This group reflects all TEAEs collected for the safety population, including those that are treatment application site specific.</description>
        </group>
        <group group_id="E2">
          <title>DUR-928 Topical Solution, Safety Population Experiencing a TEAE at the Treatment Application Site.</title>
          <description>DUR-928 Topical Solution: Topical solution containing active drug applied topically once daily to one target lesion on an arm for approximately four weeks.&#xD;
This treatment arm was only reported if the TEAE was local to the treatment application site.</description>
        </group>
        <group group_id="E3">
          <title>Vehicle Topical Solution, Safety Population Experiencing a TEAE at the Treatment Application Site.</title>
          <description>Vehicle Topical Solution: Topical solution containing no active drug applied topically once daily to one target lesion on an arm for approximately four weeks.&#xD;
This treatment arm was only reported if the TEAE was local to the treatment application site.</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="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>3</frequency_threshold>
        <default_vocab>MedDRA version 21.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Application site erythema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Application site fissure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Application site haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Application site injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Application site pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Application site pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood urine</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Pruritus generalised</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Skin burning sensation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Skin exfoliation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The disclosure agreement provides that if sponsor has not submitted a manuscript for publication within 12 months after the date of data lock and analysis at study completion at all sites, the PI can review results communications prior to public release and can embargo communications regarding trial results for a period up to 120 days from the time submitted to the sponsor for review. The PI cannot disclose SPONSOR Confidential Information without prior consent.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Executive Director of Regulatory Affairs</name_or_title>
      <organization>DURECT Corporation</organization>
      <phone>408-777-1829</phone>
      <email>jill.burns@durect.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/NCT03837743
org study id: C928-015
nct id: NCT03837743
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This Phase 2 study has been designed to determine and compare the safety, tolerability, and
      efficacy of DUR-928 topical solution with that of the vehicle topical solution when applied
      once daily for approximately four weeks in subjects with plaque psoriasis. Subjects will be
      instructed (randomly assigned) to apply DUR-928 solution to a target lesion on one arm and
      vehicle solution to a target lesion on the opposite arm once daily for up to four weeks.
      Subjects will occlude the treated areas for approximately two hours after each application.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The Change From Baseline as Assessed on the Investigator's Global Assessment (IGA) Score.
time frame: Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported)
description: The IGA of the Target Plaques will be determined on a 5-point scale. 0=Clear; 1=Almost Clear; 2=Mild; 3=Moderate; 4=Severe
measure: The Change From Baseline as Assessed on the Clinical Signs of Psoriasis (Plaque Elevation, Scaling, and Erythema)
time frame: Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported)
description: Each clinical sign (plaque elevation, scaling, erythema) will be graded on a 5-point scale.0=Clear; 1=Almost Clear; 2=Mild; 3=Moderate; 4=Severe.
measure: The Change From Baseline as Assessed on the Local Psoriasis Severity Index (LPSI)
time frame: Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported)
description: The LPSI is a sum of all three parameters (sum range of 0-12, with 12 being a worse outcome). Three parameters are plaque elevation, scaling, and erythema, each rated 0-4, 0=clear to 4=severe.
measure: The Change From Baseline as Assessed by the Target Plaque Area.
time frame: Up to Day 57 (assessed at Baseline, and Weeks 2,4,8, change from baseline to week 4 and 8 reported)
description: The surface areas of Target Plaque A (plaque on left arm) and Target Plaque B (plaque on right arm) will be measured.
measure: The Change From Baseline as Assessed on the Itch Numeric Rating Scale (I-NRS) for Pruritus.
time frame: Up to Day 57 (assessed at Baseline, and Weeks 2,4,8, change from baseline to week 4 and 8 reported)
description: The I-NRS score is based on an 11-point scale where 0 represents "no itching" and 10 represents "worst itch imaginable."
measure: The Change From Baseline as Assessed on the Target Plaque Comparison
time frame: Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported)
description: The Target Plaque Comparison is scored on a 3-point scale: 1A = Target Plaque A is better than Target Plaque B, 0 = Target Plaque A is the same as Target Plaque B, and 1B = Target Plaque A is worse than Target Plaque B.
arm group label: DUR-928 Topical Solution
arm group type: Experimental
description: DUR-928 Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks.
arm group label: Vehicle Topical Solution
arm group type: Placebo Comparator
description: Vehicle Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks.
intervention type: Drug
intervention name: DUR-928 Topical Solution
description: Topical solution containing active drug
arm group label: DUR-928 Topical Solution
intervention type: Drug
intervention name: Vehicle Topical Solution
description: Topical solution containing no active drug
arm group label: Vehicle Topical Solution
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tony Andrasfay
role: Study Director
affiliation: Therapeutics, Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Psoriasis
mesh term: Pharmaceutical Solutions
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 