<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/NCT02985736</url>
  </required_header>
  <id_info>
    <org_study_id>JB-02</org_study_id>
    <nct_id>NCT02985736</nct_id>
  </id_info>
  <brief_title>Topical Scalp Psoriasis Study Evaluating Topicort Topical Spray</brief_title>
  <official_title>An Open-Label, Study Evaluating Topicort® Topical Spray 0.25% (Desoximetasone) in Patients With Scalp Psoriasis</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 single center, study of 20 subjects to assess 4 weeks of therapy with Topicort® twice daily&#xD;
      BID and 12 weeks twice daily on 2 consecutive days to patients with scalp psoriasis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients will receive Topicort® twcie daily (BID) for 4 weeks. After week 4 patients will&#xD;
      receive Topicort® twice weekly (on consecutive days) for 12 weeks, Patients will treat other&#xD;
      body areas affected by plaque psoriasis with Topicort® during the study period (excludes&#xD;
      face, groin, axilla)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2016</start_date>
  <completion_date type="Actual">January 27, 2017</completion_date>
  <primary_completion_date type="Actual">January 27, 2017</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>Investigator Global Assessment (scalp only)</measure>
    <time_frame>16 weeks</time_frame>
    <description>Scalp psoriasis severity scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Psoriasis Scalp Severity Index</measure>
    <time_frame>16 weeks</time_frame>
    <description>Scalp psoriasis severity scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Scalp Surface Area</measure>
    <time_frame>16 weeks</time_frame>
    <description>Measures % of scalp affected with psoriasis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>body surface area multiplied by physician's global assessement</measure>
    <time_frame>16 weeks</time_frame>
    <description>measures psoriasis severity improvement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>scalpdex questionnaire</measure>
    <time_frame>16 weeks</time_frame>
    <description>patient reported outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>visual analog scale</measure>
    <time_frame>16 weeks</time_frame>
    <description>measures subject assessment of pain</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>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Topicort Topical Spray</intervention_name>
    <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 scalp psoriasis.&#xD;
&#xD;
          3. IGA of mild or greater (scalp only) determined at screening&#xD;
&#xD;
          4. Scalp surface area of 30% or greater determined at screening&#xD;
&#xD;
          5. Able to give written informed consent prior to performance of any study related&#xD;
             procedures.&#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. &lt;30% scalp surface area&#xD;
&#xD;
          2. Scalp Investigator global assessment (IGA) clear or almost clear at time of screening&#xD;
&#xD;
          3. Any condition, which would place the subject at unacceptable risk if he/she were to&#xD;
             participate in the study.&#xD;
&#xD;
          4. Pregnant or breast feeding, or considering becoming pregnant during the study.&#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. Use of ustekinumab and/or anti-IL-17 (interleukin 17) biologic therapy within 24 weeks&#xD;
             or other experimental or commercially available biologic immune modulator(s) within 12&#xD;
             weeks prior to the first IP dose.&#xD;
&#xD;
          8. Patient used other topical therapies to treat within 2 weeks of the Baseline Visit&#xD;
             (not including permitted topical therapy for face, groin and axilla).&#xD;
&#xD;
          9. Patient received ultraviolet B, UVB phototherapy within 2 weeks of Baseline.&#xD;
&#xD;
         10. Patient received psoralen and Ultraviolet A, PUVA phototherapy within 4 weeks of&#xD;
             Baseline.&#xD;
&#xD;
         11. 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>
  <location>
    <facility>
      <name>Psoriasis Treatment Center of Central New Jersey</name>
      <address>
        <city>East Windsor</city>
        <state>New Jersey</state>
        <zip>08520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>October 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>March 2, 2017</last_update_submitted>
  <last_update_submitted_qc>March 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2017</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>
  <pending_results>
    <submitted>April 6, 2018</submitted>
    <returned>May 4, 2018</returned>
    <submitted>January 29, 2019</submitted>
    <returned>February 19, 2019</returned>
  </pending_results>
  <!-- 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/NCT02985736
org study id: JB-02
nct id: NCT02985736
lead sponsor: 
collaborator: 
has dmc: No
A single center, study of 20 subjects to assess 4 weeks of therapy with Topicort® twice daily
      BID and 12 weeks twice daily on 2 consecutive days to patients with scalp psoriasis
All patients will receive Topicort® twcie daily (BID) for 4 weeks. After week 4 patients will
      receive Topicort® twice weekly (on consecutive days) for 12 weeks, Patients will treat other
      body areas affected by plaque psoriasis with Topicort® during the study period (excludes
      face, groin, axilla)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Investigator Global Assessment (scalp only)
time frame: 16 weeks
description: Scalp psoriasis severity scale
measure: Psoriasis Scalp Severity Index
time frame: 16 weeks
description: Scalp psoriasis severity scale
measure: Scalp Surface Area
time frame: 16 weeks
description: Measures % of scalp affected with psoriasis
measure: body surface area multiplied by physician's global assessement
time frame: 16 weeks
description: measures psoriasis severity improvement
measure: scalpdex questionnaire
time frame: 16 weeks
description: patient reported outcome
measure: visual analog scale
time frame: 16 weeks
description: measures subject assessment of pain
arm group label: open label
arm group type: Experimental
intervention type: Drug
intervention name: Topicort Topical Spray
arm group label: open label
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Psoriasis
mesh term: Desoximetasone
sharing ipd: No
submitted: April 6, 2018
returned: May 4, 2018
submitted: January 29, 2019
returned: February 19, 2019