xml: <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/NCT06032858</url>
    </required_header>
    <id_info>
      <org_study_id>D6</org_study_id>
      <nct_id>NCT06032858</nct_id>
    </id_info>
    <brief_title>Efficacy and Safety of Apremilast in Psoriasis</brief_title>
    <official_title>Efficacy and Safety of Apremilast in Patients With Moderate to Severe Chronic Plaque Psoriasis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ghurki Trust and Teaching Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ghurki Trust and Teaching Hospital</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>
        Psoriasis is a long standing inflammatory, autoinflammatory disease linked with many&#xD;
        comorbidities. Patients with moderate to severe plaque psoriasis can be managed with topical&#xD;
        as well as systemic medications. FDA approved Apremilast as first drug to be taken orally in&#xD;
        cases of psoriasis in mid 1990's. Currently, according to researchers best knowledge no study&#xD;
        has been done on use of Apremilast in Pakistan. It has recently become available here.&#xD;
        Keeping in view all the benefits of this drug, a study has been planned to check its&#xD;
        effectiveness and safety 30mg twice a day, in patients with moderate to severe chronic plaque&#xD;
        psoriasis based on Psoriasis area and severity index and Body surface area assessments in our&#xD;
        population.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 6, 2022</start_date>
    <completion_date type="Actual">August 10, 2023</completion_date>
    <primary_completion_date type="Actual">July 10, 2023</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 area and severity index</measure>
      <time_frame>16 weeks</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>body surface area</measure>
      <time_frame>16 weeks</time_frame>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">30</enrollment>
    <condition>Psoriasis</condition>
    <arm_group>
      <arm_group_label>Apremilast 30 mg twice daily</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Apremilast 30mg</intervention_name>
      <description>Apremilast 30mg twice daily</description>
      <arm_group_label>Apremilast 30 mg twice daily</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosed patients of chronic plaque psoriasis&#xD;
  &#xD;
            -  patients applicant for oral or parenteral treatments and for light therapy&#xD;
  &#xD;
            -  patients not responding to topical treatments&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who show hypersensitive reactions to apremilast to any of its inactive&#xD;
               component&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Lactating mothers&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>59 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Prof. Dr. Haroon Nabi</last_name>
      <role>Study Director</role>
      <affiliation>Professor Department of Dermatology LMDC</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Dr. Saira Muaaz</last_name>
      <role>Principal Investigator</role>
      <affiliation>Department of Dermatology Ghurki Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Dr. Hira Tariq</last_name>
      <role>Study Chair</role>
      <affiliation>Senior Registrar Department of Dermatology Services Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Dr. Sumera Hanif</last_name>
      <role>Study Chair</role>
      <affiliation>Senior Registrar Department of Dermatology LMDC</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Dr. Talat Akbar</last_name>
      <role>Study Chair</role>
      <affiliation>Associate Professor, Dermatology, LMDC</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Prof. Dr. Faria Asad</last_name>
      <role>Study Chair</role>
      <affiliation>Head of Department Dermatology SIMS/ Services Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Ghurki Hospital</name>
        <address>
          <city>Lahore</city>
          <state>Punjab</state>
          <zip>54000</zip>
          <country>Pakistan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <reference>
      <citation>Schafer P. Apremilast mechanism of action and application to psoriasis and psoriatic arthritis. Biochem Pharmacol. 2012 Jun 15;83(12):1583-90. doi: 10.1016/j.bcp.2012.01.001. Epub 2012 Jan 10.</citation>
      <PMID>22257911</PMID>
    </reference>
    <reference>
      <citation>Crowley J, Thaci D, Joly P, Peris K, Papp KA, Goncalves J, Day RM, Chen R, Shah K, Ferrandiz C, Cather JC. Long-term safety and tolerability of apremilast in patients with psoriasis: Pooled safety analysis for &gt;/=156 weeks from 2 phase 3, randomized, controlled trials (ESTEEM 1 and 2). J Am Acad Dermatol. 2017 Aug;77(2):310-317.e1. doi: 10.1016/j.jaad.2017.01.052. Epub 2017 Apr 14.</citation>
      <PMID>28416342</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</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>Apremilast</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06032858
  org study id: D6
  nct id: NCT06032858
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Psoriasis is a long standing inflammatory, autoinflammatory disease linked with many
        comorbidities. Patients with moderate to severe plaque psoriasis can be managed with topical
        as well as systemic medications. FDA approved Apremilast as first drug to be taken orally in
        cases of psoriasis in mid 1990's. Currently, according to researchers best knowledge no study
        has been done on use of Apremilast in Pakistan. It has recently become available here.
        Keeping in view all the benefits of this drug, a study has been planned to check its
        effectiveness and safety 30mg twice a day, in patients with moderate to severe chronic plaque
        psoriasis based on Psoriasis area and severity index and Body surface area assessments in our
        population.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Psoriasis area and severity index
  time frame: 16 weeks
  measure: body surface area
  time frame: 16 weeks
  arm group label: Apremilast 30 mg twice daily
  arm group type: Experimental
  intervention type: Drug
  intervention name: Apremilast 30mg
  description: Apremilast 30mg twice daily
  arm group label: Apremilast 30 mg twice daily
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 59 Years
  healthy volunteers: No
  last name: Prof. Dr. Haroon Nabi
  role: Study Director
  affiliation: Professor Department of Dermatology LMDC
  last name: Dr. Saira Muaaz
  role: Principal Investigator
  affiliation: Department of Dermatology Ghurki Hospital
  last name: Dr. Hira Tariq
  role: Study Chair
  affiliation: Senior Registrar Department of Dermatology Services Hospital
  last name: Dr. Sumera Hanif
  role: Study Chair
  affiliation: Senior Registrar Department of Dermatology LMDC
  last name: Dr. Talat Akbar
  role: Study Chair
  affiliation: Associate Professor, Dermatology, LMDC
  last name: Prof. Dr. Faria Asad
  role: Study Chair
  affiliation: Head of Department Dermatology SIMS/ Services Hospital
  facility: 
  country: Pakistan
  citation: Schafer P. Apremilast mechanism of action and application to psoriasis and psoriatic arthritis. Biochem Pharmacol. 2012 Jun 15;83(12):1583-90. doi: 10.1016/j.bcp.2012.01.001. Epub 2012 Jan 10.
  PMID: 22257911
  citation: Crowley J, Thaci D, Joly P, Peris K, Papp KA, Goncalves J, Day RM, Chen R, Shah K, Ferrandiz C, Cather JC. Long-term safety and tolerability of apremilast in patients with psoriasis: Pooled safety analysis for >/=156 weeks from 2 phase 3, randomized, controlled trials (ESTEEM 1 and 2). J Am Acad Dermatol. 2017 Aug;77(2):310-317.e1. doi: 10.1016/j.jaad.2017.01.052. Epub 2017 Apr 14.
  PMID: 28416342
  responsible party type: Sponsor
  mesh term: Psoriasis
  mesh term: Apremilast
  sharing ipd: No