<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/NCT02983981</url>
  </required_header>
  <id_info>
    <org_study_id>JB-01</org_study_id>
    <nct_id>NCT02983981</nct_id>
  </id_info>
  <brief_title>Topical Psoriasis Study for Patients Receiving Biologic Therapy</brief_title>
  <official_title>An Open-Label, Observational Study Evaluating Topicort® Topical Spray 0.25% (Desoximetasone) BID in Psoriasis Patients Being Treated With Biologic Agents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Psoriasis Treatment Center of Central New Jersey</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Taro Pharmaceuticals USA</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Psoriasis Treatment Center of Central New Jersey</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A two-phase, single center, study of 20 subjects to assess 4 weeks of add-on therapy of&#xD;
      Topicort® BID and 12 weeks BID on two consecutive days a week to patients with ≤5% BSA who&#xD;
      are receiving biologic therapy for at least 24 weeks&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A two-phase, single center, study of 20 subjects to assess 4 weeks of add-on therapy of&#xD;
      Topicort® BID and 12 weeks BID on two consecutive days a week to patients with ≤5% BSA who&#xD;
      are receiving biologic therapy for at least 24 weeks.&#xD;
&#xD;
      Adult male and female subjects with moderate to severe chronic plaque psoriasis All patients&#xD;
      will receive Topicort® BID for 4 weeks.&#xD;
&#xD;
      After week 4 patients will receive Topicort® BID on two consecutive days a week for 12 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2016</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Psoriasis Severity</measure>
    <time_frame>16 weeks</time_frame>
    <description>Physician's Global Assessment x Percentage of Body Surface Area (scale scores 0-400 where 0 is best psoriasis 400 is worst possible psoriasis) Body surface area calculated as 1 of patient's palm is 1%.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Psoriasis Severity</measure>
    <time_frame>16 weeks</time_frame>
    <description>Physician's Global Assessment Scores Scales 0-4 with 0 as no psoriasis and 4 is severe psoriasis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psoriasis Severity</measure>
    <time_frame>16 weeks</time_frame>
    <description>Psoriasis severity measured as Body Surface area measured as 1 of patient's palm is equal to 1% body surface area.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dermatology Life Quality Index</measure>
    <time_frame>16 weeks</time_frame>
    <description>calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Psoriasis</condition>
  <arm_group>
    <arm_group_label>open label</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Topicort topical spray</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Topicort Topical Spray</intervention_name>
    <description>open label Topicort spray</description>
    <arm_group_label>open label</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female adults ≥ 18 years of age.&#xD;
&#xD;
          2. Diagnosis of chronic plaque-type psoriasis.&#xD;
&#xD;
          3. Able to give written informed consent prior to performance of any study related&#xD;
             procedures.&#xD;
&#xD;
          4. Treated with a biologic agent for a minimum of 24 weeks at baseline.&#xD;
&#xD;
          5. Plaque-type psoriasis as defined at screening and baseline by BSA ≤ 5%.&#xD;
&#xD;
          6. Females of childbearing potential (FCBP) must have a negative pregnancy test at&#xD;
             Screening and Baseline. FCBP who engage in activity in which conception is possible&#xD;
             must use one of the approved contraceptive options: hormonal contraception;&#xD;
             intrauterine device (IUD); tubal ligation; or partner's vasectomy; Male or female&#xD;
             condom diaphragm with spermicide, cervical cap with spermicide, or contraceptive&#xD;
             sponge with spermicide.&#xD;
&#xD;
          7. Subject must be in general good health (except for psoriasis) as judged by the&#xD;
             Investigator, based on medical history, physical examination.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. &gt;5% Body Surface Area&#xD;
&#xD;
          2. Any condition, which would place the subject at unacceptable risk if he/she were to&#xD;
             participate in the study.&#xD;
&#xD;
          3. Pregnant or breast feeding, or considering becoming pregnant during the study.&#xD;
&#xD;
          4. Malignancy or history of malignancy, except for:&#xD;
&#xD;
               1. treated [ie, cured] basal cell or squamous cell in situ skin carcinomas;&#xD;
&#xD;
               2. treated [ie, cured] malignancy with no evidence of recurrence within the previous&#xD;
                  5 years.&#xD;
&#xD;
          5. Use of any investigational drug within 4 weeks prior to randomization, or within 5&#xD;
             pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).&#xD;
&#xD;
          6. Use of oral systemic medications for the treatment of psoriasis within 4 weeks&#xD;
             (includes, but not limited to, oral corticosteroids, methotrexate, acitretin,&#xD;
             apremilast and cyclosporine).&#xD;
&#xD;
          7. Patient used other topical therapies to treat within 2 weeks of the Baseline Visit&#xD;
             (includes, but not limited to, topical corticosteroids, vitamin D analogs, or&#xD;
             retinoids).&#xD;
&#xD;
          8. Patient received UVB phototherapy within 2 weeks of Baseline.&#xD;
&#xD;
          9. Patient received PUVA phototherapy within 4 weeks of Baseline.&#xD;
&#xD;
         10. Patient has a known hypersensitivity to the excipients of Topicort Spray® as stated in&#xD;
             the label.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jerry Bagel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Director</affiliation>
  </overall_official>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>October 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <results_first_submitted>December 21, 2017</results_first_submitted>
  <results_first_submitted_qc>April 4, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">May 7, 2018</results_first_posted>
  <last_update_submitted>December 28, 2018</last_update_submitted>
  <last_update_submitted_qc>December 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Desoximetasone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Topicort Topical Spray</title>
          <description>Topicort spray applied BID for 4 weeks followed by BID on 2 consecutive days through week 16</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Open Label</title>
          <description>Topicort topical spray&#xD;
Topicort Topical Spray: open label Topicort spray applied twice daily for 4 weeks followed by twice daily BID on two consecutive days a week (e.g. Saturday and Sunday) for 12 weeks.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
          </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="53.33" spread="7.92"/>
                  </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="5"/>
                  </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>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="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Psoriasis Severity</title>
        <description>Physician's Global Assessment x Percentage of Body Surface Area (scale scores 0-400 where 0 is best psoriasis 400 is worst possible psoriasis) Body surface area calculated as 1 of patient's palm is 1%.</description>
        <time_frame>16 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Open Label</title>
            <description>Topicort topical spray&#xD;
Topicort Topical Spray: open label Topicort spray</description>
          </group>
        </group_list>
        <measure>
          <title>Psoriasis Severity</title>
          <description>Physician's Global Assessment x Percentage of Body Surface Area (scale scores 0-400 where 0 is best psoriasis 400 is worst possible psoriasis) Body surface area calculated as 1 of patient's palm is 1%.</description>
          <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="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.25" spread="5.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Psoriasis Severity</title>
        <description>Physician's Global Assessment Scores Scales 0-4 with 0 as no psoriasis and 4 is severe psoriasis</description>
        <time_frame>16 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Open Label</title>
            <description>Topicort topical spray&#xD;
Topicort Topical Spray: open label Topicort spray</description>
          </group>
        </group_list>
        <measure>
          <title>Psoriasis Severity</title>
          <description>Physician's Global Assessment Scores Scales 0-4 with 0 as no psoriasis and 4 is severe psoriasis</description>
          <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="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.65" spread=".89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Psoriasis Severity</title>
        <description>Psoriasis severity measured as Body Surface area measured as 1 of patient's palm is equal to 1% body surface area.</description>
        <time_frame>16 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Open Label</title>
            <description>Topicort topical spray&#xD;
Topicort Topical Spray: open label Topicort spray</description>
          </group>
        </group_list>
        <measure>
          <title>Psoriasis Severity</title>
          <description>Psoriasis severity measured as Body Surface area measured as 1 of patient's palm is equal to 1% body surface area.</description>
          <units>percentage of BSA</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.05" spread="2.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Dermatology Life Quality Index</title>
        <description>calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.</description>
        <time_frame>16 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Open Label</title>
            <description>Topicort topical spray&#xD;
Topicort Topical Spray: open label Topicort spray</description>
          </group>
        </group_list>
        <measure>
          <title>Dermatology Life Quality Index</title>
          <description>calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.</description>
          <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="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.65" spread="4.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Open Label</title>
          <description>Topicort topical spray&#xD;
Topicort Topical Spray: open label Topicort spray</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="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>cough/congestion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>hyperglycemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>sciatic neuralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>worsening of psoriasis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>erythema multiforme</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Jerry Bagel Director of Clinical Trials</name_or_title>
      <organization>Psoriasis Treatment Center of Central New Jersey</organization>
      <phone>6094434500</phone>
      <email>dreamacres1@aol.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/NCT02983981
org study id: JB-01
nct id: NCT02983981
lead sponsor: 
collaborator: 
has dmc: No
A two-phase, single center, study of 20 subjects to assess 4 weeks of add-on therapy of
      Topicort® BID and 12 weeks BID on two consecutive days a week to patients with ≤5% BSA who
      are receiving biologic therapy for at least 24 weeks
A two-phase, single center, study of 20 subjects to assess 4 weeks of add-on therapy of
      Topicort® BID and 12 weeks BID on two consecutive days a week to patients with ≤5% BSA who
      are receiving biologic therapy for at least 24 weeks.

      Adult male and female subjects with moderate to severe chronic plaque psoriasis All patients
      will receive Topicort® BID for 4 weeks.

      After week 4 patients will receive Topicort® BID on two consecutive days a week for 12 weeks.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Psoriasis Severity
time frame: 16 weeks
description: Physician's Global Assessment x Percentage of Body Surface Area (scale scores 0-400 where 0 is best psoriasis 400 is worst possible psoriasis) Body surface area calculated as 1 of patient's palm is 1%.
measure: Psoriasis Severity
time frame: 16 weeks
description: Physician's Global Assessment Scores Scales 0-4 with 0 as no psoriasis and 4 is severe psoriasis
measure: Psoriasis Severity
time frame: 16 weeks
description: Psoriasis severity measured as Body Surface area measured as 1 of patient's palm is equal to 1% body surface area.
measure: Dermatology Life Quality Index
time frame: 16 weeks
description: calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
arm group label: open label
arm group type: Experimental
description: Topicort topical spray
intervention type: Drug
intervention name: Topicort Topical Spray
description: open label Topicort spray
arm group label: open label
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Jerry Bagel, MD
role: Principal Investigator
affiliation: Director
responsible party type: Sponsor
mesh term: Psoriasis
mesh term: Desoximetasone
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 