<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/NCT03000608</url>
  </required_header>
  <id_info>
    <org_study_id>SAN021-03</org_study_id>
    <nct_id>NCT03000608</nct_id>
  </id_info>
  <brief_title>A Trial of a Botanical Drug (EISO) for Treatment of Mild-to-Moderate Plaque Psoriasis</brief_title>
  <official_title>A Double-Blind, Multi-Center, Randomized, Placebo Controlled Safety, Tolerability &amp; Efficacy Trial Of A New Botanical Drug Product Containing East Indian Sandalwood Oil (EISO) For The Treatment Of Mild-To-Moderate Plaque Psoriasis In Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Santalis Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ClinDatrix, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Clinical Trials of Texas, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dermatology Research Center of San Antonio</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Derm Research, PLLC</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Progressive Clinical Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Santalis Pharmaceuticals, Inc.</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 trial will be a double-blind, multi-center, randomized, placebo controlled study to&#xD;
      evaluate the safety, tolerability, and efficacy of SAN021 study drug when administered for up&#xD;
      to 42 days to adults between the ages of 18 to 65 years who have a clinical diagnosis of&#xD;
      mild-to-moderate plaque psoriasis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will enter the Screening Period once the informed consent and photographic consent&#xD;
      process has been completed. Patients with mild-to-moderate plaque psoriasis, as defined by a&#xD;
      Psoriasis Area and Severity Index (PASI) score between 2 and 12, appropriate for topical&#xD;
      treatment that covers a minimum of 1.0% and a maximum of 10% BSA, in the permitted treatment&#xD;
      areas, and who meet all of the inclusion and none of the exclusion criteria will be enrolled.&#xD;
&#xD;
      Once subject eligibility is confirmed and the screening procedures completed, all enrolled&#xD;
      subjects will start the Treatment Period of the study. All enrolled subjects will receive&#xD;
      either 10% SAN021 or placebo serum (randomized in a 2:1 ratio) with the first dose applied at&#xD;
      the Day 1 Study Visit. Subjects will be instructed on how to apply the study medication twice&#xD;
      daily for 42 days.&#xD;
&#xD;
      Subjects will return to the clinic for study-related assessments on Study Days 7, 14, 28 and&#xD;
      a final visit on Day 42. On Study Day 49, subject will receive a Follow-up phone call and be&#xD;
      queried for condition status since going off study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 17, 2017</start_date>
  <completion_date type="Actual">December 14, 2017</completion_date>
  <primary_completion_date type="Actual">December 13, 2017</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>Patients Achieving a Physician's Global Assessment of &quot;Clear&quot; or &quot;Almost Clear&quot; at Any Time-point From Baseline to Day 42 of the Study</measure>
    <time_frame>Any time-point from Baseline to Day 42</time_frame>
    <description>The primary preliminary efficacy endpoint will be number of patients achieving a Physician's Global Assessment of &quot;clear&quot; or &quot;almost clear&quot; at any time-point during the 42 days of therapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patients Achieving a Psoriasis Area and Severity Index Score Improvement ≥50% at Any Time-point From Baseline to Day 42 of the Study.</measure>
    <time_frame>Any time-point from Baseline to Day 42 of the study.</time_frame>
    <description>Percentage of patients who have a ≥50% reduction in the Psoriasis Area Severity Index (PASI) score at any time-point from Baseline to Day 42 of the study.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">69</enrollment>
  <condition>Plaque Psoriasis</condition>
  <arm_group>
    <arm_group_label>SAN021 Serum</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SAN021 is a serum containing 10% East Indian Sandalwood Oil. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SAN021 Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>SAN021 Placebo is a serum that does not contain East Indian Sandalwood Oil however, does contain a synthetic sandalwood fragrance. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SAN021 Serum</intervention_name>
    <description>SAN021 is a serum containing 10% East Indian Sandalwood Oil. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.</description>
    <arm_group_label>SAN021 Serum</arm_group_label>
    <other_name>Active</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SAN021 Placebo</intervention_name>
    <description>SAN021 Placebo is a serum that does not contain East Indian Sandalwood Oil however, does contain a synthetic sandalwood fragrance. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.</description>
    <arm_group_label>SAN021 Placebo</arm_group_label>
    <other_name>Placebo Serum</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Are ≥18 but ≤65 years of age&#xD;
&#xD;
          -  Have a clinical diagnosis of mild-to-moderate plaque psoriasis, as defined by a&#xD;
             Psoriasis Area and Severity Index (PASI) score between 2 and 12, appropriate for&#xD;
             topical treatment that covers a minimum of 1.0% and a maximum of 10% Body Surface Area&#xD;
             (BSA), in the permitted treatment areas.&#xD;
&#xD;
          -  Are willing to treat all psoriasis occurring in the permitted treatment areas with&#xD;
             only SAN021&#xD;
&#xD;
          -  Are free of any systemic or dermatologic disorder, which, in the opinion of the&#xD;
             investigator, will interfere with the study results or increase the risk of adverse&#xD;
             events.&#xD;
&#xD;
          -  Are willing to avoid prolonged exposure of the treatment area to ultraviolet radiation&#xD;
             (natural or artificial) for the duration of the study.&#xD;
&#xD;
          -  Are willing to refrain from using any lotions, moisturizer, cleansers, cosmetics or&#xD;
             creams, other than those issued as part of the study, on the treatment areas during&#xD;
             the treatment period.&#xD;
&#xD;
          -  If female of childbearing potential, must be willing to practice an acceptable form of&#xD;
             birth control for the duration of the study.&#xD;
&#xD;
          -  Are able to give written informed consent in a manner approved by the Institutional&#xD;
             Review Board or Ethics Review Committee and comply with the requirements of the study.&#xD;
&#xD;
          -  Are willing to avoid participation in any other interventional clinical trial for the&#xD;
             duration of this study.&#xD;
&#xD;
          -  Are willing to refrain from treating restricted areas, which will be excluded from the&#xD;
             PGA assessments and Body Surface Area (BSA) calculation. These areas are as follows:&#xD;
             head, neck, fingernails, toenails, soles of feet, and palms of hands, axillae, or&#xD;
             intertriginous areas.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have spontaneously improving or rapidly deteriorating plaque psoriasis, or pustular&#xD;
             psoriasis as determined by the Investigator.&#xD;
&#xD;
          -  Have been treated, with prescription medication for plaque psoriasis, with no&#xD;
             improvement in condition, within 60 days prior to the Baseline visit.&#xD;
&#xD;
          -  Are pregnant, breast-feeding, or planning to become pregnant during the study.&#xD;
&#xD;
          -  Have any evidence of systemic cancer, squamous cell carcinoma, basal cell carcinoma,&#xD;
             in the last 5 years, or any other confounding skin condition.&#xD;
&#xD;
          -  Are undergoing treatments with topical antipsoriatic drug products other than&#xD;
             corticosteroids within 14 days prior to the Baseline Visit, and for therapy containing&#xD;
             corticosteroids or retinoids within 28 days prior to Baseline Visit.&#xD;
&#xD;
          -  Have open sores or open lesions in the treatment area(s).&#xD;
&#xD;
          -  Have any condition that, in the opinion of the investigator, would confound the safety&#xD;
             and/or efficacy assessments of plaque psoriasis.&#xD;
&#xD;
          -  Have participated in any interventional clinical trial in the previous 30 days.&#xD;
&#xD;
          -  Have a known sensitivity to any of the constituents of the test product including&#xD;
             sensitivities to sandalwood oil, fragrances, or any member of the Compositae family of&#xD;
             vascular plants (e.g., sunflowers, daisies, dahlias, etc.).&#xD;
&#xD;
          -  Have used, are using, or are planning to use immunosuppressive or immunomodulatory&#xD;
             medication (i.e., biologics), including oral or parenteral corticosteroids.&#xD;
&#xD;
          -  Have a history of alcohol or illegal drug/substance abuse, or suspected alcohol or&#xD;
             illegal drug/substance abuse in the past 2 years.&#xD;
&#xD;
          -  Plan to seek alternative treatment of any kind for their psoriasis, in the eligible&#xD;
             treatment areas or otherwise, during the trial period.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>DermResearch, Inc.</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78759</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Progressive Clinical Research</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial of Texas</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Dermatology Clinical Research Center of San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <results_first_submitted>April 11, 2019</results_first_submitted>
  <results_first_submitted_qc>May 6, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">May 29, 2019</results_first_posted>
  <last_update_submitted>May 6, 2019</last_update_submitted>
  <last_update_submitted_qc>May 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2019</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 8, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/08/NCT03000608/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 20, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/08/NCT03000608/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>SAN021 Serum</title>
          <description>SAN021 is a serum containing 10% East Indian Sandalwood Oil. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.&#xD;
SAN021 Serum: SAN021 is a serum containing 10% East Indian Sandalwood Oil. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.</description>
        </group>
        <group group_id="P2">
          <title>SAN021 Placebo</title>
          <description>SAN021 Placebo is a serum that does not contain East Indian Sandalwood Oil however, does contain a synthetic sandalwood fragrance. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.&#xD;
SAN021 Placebo: SAN021 Placebo is a serum that does not contain East Indian Sandalwood Oil however, does contain a synthetic sandalwood fragrance. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
                <participants group_id="P2" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>SAN021 Serum</title>
          <description>SAN021 is a serum containing 10% East Indian Sandalwood Oil. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.&#xD;
SAN021 Serum: SAN021 is a serum containing 10% East Indian Sandalwood Oil. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.</description>
        </group>
        <group group_id="B2">
          <title>SAN021 Placebo</title>
          <description>SAN021 Placebo is a serum that does not contain East Indian Sandalwood Oil however, does contain a synthetic sandalwood fragrance. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.&#xD;
SAN021 Placebo: SAN021 Placebo is a serum that does not contain East Indian Sandalwood Oil however, does contain a synthetic sandalwood fragrance. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.</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="46"/>
            <count group_id="B2" value="23"/>
            <count group_id="B3" value="69"/>
          </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="43.8" spread="11.78"/>
                    <measurement group_id="B2" value="47.0" spread="11.96"/>
                    <measurement group_id="B3" value="44.9" spread="11.85"/>
                  </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="23"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>American Indian/ Alaskan Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </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="46"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="169.93" spread="8.804"/>
                    <measurement group_id="B2" value="165.48" spread="12.9841"/>
                    <measurement group_id="B3" value="168.45" spread="10.446"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="96.62" spread="27.863"/>
                    <measurement group_id="B2" value="84.58" spread="18.352"/>
                    <measurement group_id="B3" value="92.61" spread="25.601"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Patients Achieving a Physician's Global Assessment of &quot;Clear&quot; or &quot;Almost Clear&quot; at Any Time-point From Baseline to Day 42 of the Study</title>
        <description>The primary preliminary efficacy endpoint will be number of patients achieving a Physician's Global Assessment of &quot;clear&quot; or &quot;almost clear&quot; at any time-point during the 42 days of therapy.</description>
        <time_frame>Any time-point from Baseline to Day 42</time_frame>
        <population>The analysis population for this outcome measure is the FAS set.</population>
        <group_list>
          <group group_id="O1">
            <title>SAN021 Serum</title>
            <description>SAN021 is a serum containing 10% East Indian Sandalwood Oil. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.&#xD;
SAN021 Serum: SAN021 is a serum containing 10% East Indian Sandalwood Oil. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.</description>
          </group>
          <group group_id="O2">
            <title>SAN021 Placebo</title>
            <description>SAN021 Placebo is a serum that does not contain East Indian Sandalwood Oil however, does contain a synthetic sandalwood fragrance. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.&#xD;
SAN021 Placebo: SAN021 Placebo is a serum that does not contain East Indian Sandalwood Oil however, does contain a synthetic sandalwood fragrance. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Patients Achieving a Physician's Global Assessment of &quot;Clear&quot; or &quot;Almost Clear&quot; at Any Time-point From Baseline to Day 42 of the Study</title>
          <description>The primary preliminary efficacy endpoint will be number of patients achieving a Physician's Global Assessment of &quot;clear&quot; or &quot;almost clear&quot; at any time-point during the 42 days of therapy.</description>
          <population>The analysis population for this outcome measure is the FAS set.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patients Achieving a Psoriasis Area and Severity Index Score Improvement ≥50% at Any Time-point From Baseline to Day 42 of the Study.</title>
        <description>Percentage of patients who have a ≥50% reduction in the Psoriasis Area Severity Index (PASI) score at any time-point from Baseline to Day 42 of the study.</description>
        <time_frame>Any time-point from Baseline to Day 42 of the study.</time_frame>
        <population>The analysis set used for this outcome measure is the FAS set.</population>
        <group_list>
          <group group_id="O1">
            <title>SAN021 Serum</title>
            <description>SAN021 is a serum containing 10% East Indian Sandalwood Oil. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.&#xD;
SAN021 Serum: SAN021 is a serum containing 10% East Indian Sandalwood Oil. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.</description>
          </group>
          <group group_id="O2">
            <title>SAN021 Placebo</title>
            <description>SAN021 Placebo is a serum that does not contain East Indian Sandalwood Oil however, does contain a synthetic sandalwood fragrance. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.&#xD;
SAN021 Placebo: SAN021 Placebo is a serum that does not contain East Indian Sandalwood Oil however, does contain a synthetic sandalwood fragrance. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Patients Achieving a Psoriasis Area and Severity Index Score Improvement ≥50% at Any Time-point From Baseline to Day 42 of the Study.</title>
          <description>Percentage of patients who have a ≥50% reduction in the Psoriasis Area Severity Index (PASI) score at any time-point from Baseline to Day 42 of the study.</description>
          <population>The analysis set used for this outcome measure is the FAS set.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Over the course of the trial, AE information was collected. The trial was a 42 day trial.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>SAN021 Serum</title>
          <description>SAN021 is a serum containing 10% East Indian Sandalwood Oil. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.&#xD;
SAN021 Serum: SAN021 is a serum containing 10% East Indian Sandalwood Oil. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.</description>
        </group>
        <group group_id="E2">
          <title>SAN021 Placebo</title>
          <description>SAN021 Placebo is a serum that does not contain East Indian Sandalwood Oil however, does contain a synthetic sandalwood fragrance. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.&#xD;
SAN021 Placebo: SAN021 Placebo is a serum that does not contain East Indian Sandalwood Oil however, does contain a synthetic sandalwood fragrance. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <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="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Subcutaneous Abcess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <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="4" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Paul Castella</name_or_title>
      <organization>Santalis Pharmaceuticals</organization>
      <phone>2103992316 ext 101</phone>
      <email>paulc@santalispharmaceuticals.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/NCT03000608
org study id: SAN021-03
nct id: NCT03000608
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This trial will be a double-blind, multi-center, randomized, placebo controlled study to
      evaluate the safety, tolerability, and efficacy of SAN021 study drug when administered for up
      to 42 days to adults between the ages of 18 to 65 years who have a clinical diagnosis of
      mild-to-moderate plaque psoriasis.
Patients will enter the Screening Period once the informed consent and photographic consent
      process has been completed. Patients with mild-to-moderate plaque psoriasis, as defined by a
      Psoriasis Area and Severity Index (PASI) score between 2 and 12, appropriate for topical
      treatment that covers a minimum of 1.0% and a maximum of 10% BSA, in the permitted treatment
      areas, and who meet all of the inclusion and none of the exclusion criteria will be enrolled.

      Once subject eligibility is confirmed and the screening procedures completed, all enrolled
      subjects will start the Treatment Period of the study. All enrolled subjects will receive
      either 10% SAN021 or placebo serum (randomized in a 2:1 ratio) with the first dose applied at
      the Day 1 Study Visit. Subjects will be instructed on how to apply the study medication twice
      daily for 42 days.

      Subjects will return to the clinic for study-related assessments on Study Days 7, 14, 28 and
      a final visit on Day 42. On Study Day 49, subject will receive a Follow-up phone call and be
      queried for condition status since going off study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Patients Achieving a Physician's Global Assessment of "Clear" or "Almost Clear" at Any Time-point From Baseline to Day 42 of the Study
time frame: Any time-point from Baseline to Day 42
description: The primary preliminary efficacy endpoint will be number of patients achieving a Physician's Global Assessment of "clear" or "almost clear" at any time-point during the 42 days of therapy.
measure: Patients Achieving a Psoriasis Area and Severity Index Score Improvement ≥50% at Any Time-point From Baseline to Day 42 of the Study.
time frame: Any time-point from Baseline to Day 42 of the study.
description: Percentage of patients who have a ≥50% reduction in the Psoriasis Area Severity Index (PASI) score at any time-point from Baseline to Day 42 of the study.
arm group label: SAN021 Serum
arm group type: Experimental
description: SAN021 is a serum containing 10% East Indian Sandalwood Oil. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.
arm group label: SAN021 Placebo
arm group type: Placebo Comparator
description: SAN021 Placebo is a serum that does not contain East Indian Sandalwood Oil however, does contain a synthetic sandalwood fragrance. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.
intervention type: Drug
intervention name: SAN021 Serum
description: SAN021 is a serum containing 10% East Indian Sandalwood Oil. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.
arm group label: SAN021 Serum
other name: Active
intervention type: Drug
intervention name: SAN021 Placebo
description: SAN021 Placebo is a serum that does not contain East Indian Sandalwood Oil however, does contain a synthetic sandalwood fragrance. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.
arm group label: SAN021 Placebo
other name: Placebo Serum
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Psoriasis
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 