<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/NCT02993328</url>
  </required_header>
  <id_info>
    <org_study_id>SAN021-02</org_study_id>
    <nct_id>NCT02993328</nct_id>
  </id_info>
  <brief_title>A Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) for Treatment of Plaque Psoriasis in Adults</brief_title>
  <official_title>A Double-Blind, Randomized, Placebo Controlled Safety, Tolerability &amp; Efficacy Trial Of A New Botanical Drug Product At One Dose Level For The Treatment Of Mild-To-Moderate Plaque Psoriasis In Adult Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Santalis Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fremantle Dermatology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>ClinDatrix, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Santalis Pharmaceuticals, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</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, single-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 12,36 appropriate for topical&#xD;
      treatment that covers a minimum of 0.5% 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 8, 15, 29 and&#xD;
      a final visit on Day 43. On Study Day 50, 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>Withdrawn</overall_status>
  <why_stopped>
    Study location changed&#xD;
  </why_stopped>
  <start_date type="Anticipated">June 10, 2018</start_date>
  <completion_date type="Anticipated">January 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">January 1, 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>Safety measured by Adverse Events</measure>
    <time_frame>Total from Baseline to Day 43</time_frame>
    <description>Safety will be assessed by evaluating adverse events (AEs) with respect to severity, duration, and relationship to study drug.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients reporting discomfort during or immediately following SAN021 application</measure>
    <time_frame>Patient reported from Baseline to Day 43</time_frame>
    <description>Tolerability will be based on the number of patients reporting discomfort during or immediately following application of SAN021.</description>
  </primary_outcome>
  <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 43 of the study.</measure>
    <time_frame>Any time-point from Baseline to Day 43</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 43 days of therapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patients achieving at least a one grade improvement in Physicians Global Assessment score at any time-point from Baseline to Day 43 of the study.</measure>
    <time_frame>Any time-point from Baseline to Day 43</time_frame>
    <description>Percentage of patients achieving at least a 1-grade improvement in Physicians Global Assessment score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients achieving a Psoriasis Area and Severity Index Score Improvement ≥ 25% at any time-point from Baseline to Day 43 of the study.</measure>
    <time_frame>Any time-point from Baseline to Day 43</time_frame>
    <description>percentage of patients who have a ≥ 25% reduction in the Psoriasis Area and Severity Index (PASI) score at any time-point from Baseline to Day 43 of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients achieving a two grade improvement in Physicians Global Assessment score at any time-point from Baseline to Day 43 of the study.</measure>
    <time_frame>Any time-point from Baseline to Day 43 of the study</time_frame>
    <description>percentage of patients achieving a 2-grade improvement in the Physicians Global Assessment score at any time-point from Baseline to Day 43 of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients achieving a Psoriasis Area and Severity Index Score Improvement ≥50% at any time-point from Baseline to Day 43 of the study.</measure>
    <time_frame>Any time-point from Baseline to Day 43 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 43 of the study.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</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;
          1. Are ≥18 but ≤65 years of age&#xD;
&#xD;
          2. 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 12,36 appropriate for&#xD;
             topical treatment that covers a minimum of 0.5% and a maximum of 10% Body Surface Area&#xD;
             (BSA), in the permitted treatment areas.&#xD;
&#xD;
          3. Are willing to treat all psoriasis occurring in the permitted treatment areas with&#xD;
             only SAN021&#xD;
&#xD;
          4. 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;
          5. 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;
          6. 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;
          7. 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;
          8. 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;
          9. Are willing to avoid participation in any other clinical trial for the duration of&#xD;
             this study.&#xD;
&#xD;
         10. Are willing to refrain from treating restricted areas, which will be excluded from all&#xD;
             assessments and Body Surface Area (BSA) calculation. These areas are as follows: head,&#xD;
             neck, fingernails, toenails, soles of feet, and palms of hands, axillae, or&#xD;
             intertriginous areas.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Have spontaneously improving or rapidly deteriorating plaque psoriasis, or pustular&#xD;
             psoriasis as determined by the Investigator.&#xD;
&#xD;
          2. 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;
          3. Are pregnant, breast-feeding, or planning to become pregnant during the study.&#xD;
&#xD;
          4. Have any evidence of systemic cancer, squamous cell carcinoma, basal cell carcinoma,&#xD;
             or any other confounding skin condition.&#xD;
&#xD;
          5. 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;
          6. Have open sores or open lesions in the treatment area(s).&#xD;
&#xD;
          7. Have any condition that, in the opinion of the investigator, would confound the safety&#xD;
             and/or efficacy assessments of plaque psoriasis.&#xD;
&#xD;
          8. Have participated in any interventional clinical trial in the previous 30 days.&#xD;
&#xD;
          9. 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;
         10. Have used, are using, or are planning to use immunosuppressive or immunomodulatory&#xD;
             medication (i.e., biologics), including oral or parenteral corticosteroids.&#xD;
&#xD;
         11. Have a history of alcohol or illegal drug/substance abuse, or suspected alcohol or&#xD;
             illegal drug/substance abuse in the past two years.&#xD;
&#xD;
         12. 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>Dermatology West</name>
      <address>
        <city>Fremantle</city>
        <state>Western Australia</state>
        <zip>6160</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>January 15, 2019</last_update_submitted>
  <last_update_submitted_qc>January 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 17, 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>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02993328
org study id: SAN021-02
nct id: NCT02993328
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This trial will be a double-blind, single-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 12,36 appropriate for topical
      treatment that covers a minimum of 0.5% 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 8, 15, 29 and
      a final visit on Day 43. On Study Day 50, 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: Safety measured by Adverse Events
time frame: Total from Baseline to Day 43
description: Safety will be assessed by evaluating adverse events (AEs) with respect to severity, duration, and relationship to study drug.
measure: Number of patients reporting discomfort during or immediately following SAN021 application
time frame: Patient reported from Baseline to Day 43
description: Tolerability will be based on the number of patients reporting discomfort during or immediately following application of SAN021.
measure: Patients achieving a Physician's Global Assessment of "clear" or "almost clear" at any time-point from Baseline to day 43 of the study.
time frame: Any time-point from Baseline to Day 43
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 43 days of therapy.
measure: Patients achieving at least a one grade improvement in Physicians Global Assessment score at any time-point from Baseline to Day 43 of the study.
time frame: Any time-point from Baseline to Day 43
description: Percentage of patients achieving at least a 1-grade improvement in Physicians Global Assessment score.
measure: Patients achieving a Psoriasis Area and Severity Index Score Improvement ≥ 25% at any time-point from Baseline to Day 43 of the study.
time frame: Any time-point from Baseline to Day 43
description: percentage of patients who have a ≥ 25% reduction in the Psoriasis Area and Severity Index (PASI) score at any time-point from Baseline to Day 43 of the study.
measure: Patients achieving a two grade improvement in Physicians Global Assessment score at any time-point from Baseline to Day 43 of the study.
time frame: Any time-point from Baseline to Day 43 of the study
description: percentage of patients achieving a 2-grade improvement in the Physicians Global Assessment score at any time-point from Baseline to Day 43 of the study.
measure: Patients achieving a Psoriasis Area and Severity Index Score Improvement ≥50% at any time-point from Baseline to Day 43 of the study.
time frame: Any time-point from Baseline to Day 43 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 43 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: 
country: Australia
responsible party type: Sponsor
mesh term: Psoriasis
sharing ipd: No