<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/NCT03827876</url>
  </required_header>
  <id_info>
    <org_study_id>PTC04</org_study_id>
    <nct_id>NCT03827876</nct_id>
  </id_info>
  <brief_title>Enstilar in Combination With Enbrel or Humira for Plaque Psoriasis</brief_title>
  <official_title>An Open-Label Study Evaluating Enstilar® (Calcipotriene and Betamethasone Dipropionate) Foam, 0.005%/0.064% QD in Psoriasis Patients Being Treated With Etanercept or Adalimumab</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Psoriasis Treatment Center of Central New Jersey</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>LEO Pharma</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Psoriasis Treatment Center of Central New Jersey</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      4 weeks of adjunctive therapy of Enstilar® QD followed by 12 weeks QOD to patients with 2-10%&#xD;
      BSA who are receiving etanercept or adalimumab for at least 24 weeks&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      30 subjects treated with etanercept or adalimumab for at least 24 weeks with a body surface&#xD;
      area 2-10% and physician global assessment greater than or equal to 2 will receive Enstilar®&#xD;
      once daily for 4 weeks followed by QOD for 12 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 16, 2019</start_date>
  <completion_date type="Anticipated">December 15, 2019</completion_date>
  <primary_completion_date type="Anticipated">September 15, 2019</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>
    <intervention_model_description>open label</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PGA x BSA improvement</measure>
    <time_frame>16 weeks</time_frame>
    <description>body surface area multiplied by physician global assessment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>BSA improvement</measure>
    <time_frame>16 weeks</time_frame>
    <description>body surface area improvement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dermatology Life Quality Index improvement</measure>
    <time_frame>16 weeks</time_frame>
    <description>patient reported outcome improvements of DLQI (Dermatology Life Quality Index). 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. The DLQI can also be expressed as a percentage of the maximum possible score of 30.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Itch Numerical Rating Scale</measure>
    <time_frame>16 weeks</time_frame>
    <description>Patient reported itch scale from 0 (no itch) to 10 (worst imaginable itch).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Psoriasis</condition>
  <arm_group>
    <arm_group_label>Open Label Enstilar</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>once daily for 4 weeks followed by QOD for 12 weeks for patients receiving Enbrel or Humira</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Enstilar 0.005%-0.064% Topical Foam</intervention_name>
    <description>Enstilar 0.005%-0.064% Topical Foam applied once daily for 4 weeks followed by QOD for 12 weeks for patients receiving Enbrel or Humira</description>
    <arm_group_label>Open Label Enstilar</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female adult ≥ 18 years of age;&#xD;
&#xD;
          -  Diagnosis of chronic plaque-type&#xD;
&#xD;
          -  Patient with 2-10% BSA&#xD;
&#xD;
          -  Physician Global Assessment of 2 or greater&#xD;
&#xD;
          -  Patient has been treated with etanercept or adalimumab for a minimum of 24 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ˂2 or &gt;10% BSA&#xD;
&#xD;
          -  PGA &lt;2&#xD;
&#xD;
          -  Patient not receiving etanercept or adalimumab, or receiving etanercept or adalimumab&#xD;
             &lt;24weeks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jerry Bagel, MD</last_name>
    <phone>6094434500</phone>
    <email>dreamacres1@aol.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Elise Nelson</last_name>
    <phone>6094434500</phone>
    <email>enelson@windsordermatology.com</email>
  </overall_contact_backup>
  <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>
    <status>Recruiting</status>
    <contact>
      <last_name>Elise Nelson</last_name>
      <phone>609-443-4500</phone>
      <phone_ext>1402</phone_ext>
      <email>enelson@windsordermatology.com</email>
    </contact>
    <investigator>
      <last_name>Jerry Bagel, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Brian Keegan, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>David Nieves, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Alexa Hetzel, PA-C</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>January 31, 2019</last_update_submitted>
  <last_update_submitted_qc>January 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 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>Calcitriol</mesh_term>
    <mesh_term>Betamethasone</mesh_term>
    <mesh_term>Betamethasone-17,21-dipropionate</mesh_term>
    <mesh_term>Calcipotriene</mesh_term>
  </intervention_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/NCT03827876
org study id: PTC04
nct id: NCT03827876
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
4 weeks of adjunctive therapy of Enstilar® QD followed by 12 weeks QOD to patients with 2-10%
      BSA who are receiving etanercept or adalimumab for at least 24 weeks
30 subjects treated with etanercept or adalimumab for at least 24 weeks with a body surface
      area 2-10% and physician global assessment greater than or equal to 2 will receive Enstilar®
      once daily for 4 weeks followed by QOD for 12 weeks.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: open label
primary purpose: Treatment
masking: None (Open Label)
measure: PGA x BSA improvement
time frame: 16 weeks
description: body surface area multiplied by physician global assessment
measure: BSA improvement
time frame: 16 weeks
description: body surface area improvement
measure: Dermatology Life Quality Index improvement
time frame: 16 weeks
description: patient reported outcome improvements of DLQI (Dermatology Life Quality Index). 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. The DLQI can also be expressed as a percentage of the maximum possible score of 30.
measure: Itch Numerical Rating Scale
time frame: 16 weeks
description: Patient reported itch scale from 0 (no itch) to 10 (worst imaginable itch).
arm group label: Open Label Enstilar
arm group type: Experimental
description: once daily for 4 weeks followed by QOD for 12 weeks for patients receiving Enbrel or Humira
intervention type: Drug
intervention name: Enstilar 0.005%-0.064% Topical Foam
description: Enstilar 0.005%-0.064% Topical Foam applied once daily for 4 weeks followed by QOD for 12 weeks for patients receiving Enbrel or Humira
arm group label: Open Label Enstilar
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jerry Bagel, MD
phone: 6094434500
email: dreamacres1@aol.com
last name: Elise Nelson
phone: 6094434500
email: enelson@windsordermatology.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Psoriasis
mesh term: Calcitriol
mesh term: Betamethasone
mesh term: Betamethasone-17,21-dipropionate
mesh term: Calcipotriene
sharing ipd: No