<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/NCT03791216</url>
  </required_header>
  <id_info>
    <org_study_id>2019-2361</org_study_id>
    <nct_id>NCT03791216</nct_id>
  </id_info>
  <brief_title>Characterization of Lipoprotein Composition and Function in Pediatric Psoriasis Before and After Treatment</brief_title>
  <official_title>Characterization of Lipoprotein Composition and Function in Pediatric Psoriasis Before and After Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Psoriasis Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Children's Hospital of Philadelphia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Radboud University Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Northwestern University</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 study will assess differences in inflammatory proteins, lipoprotein composition,&#xD;
      cholesterol efflux and HDL-proteome in moderate-to-severe pediatric psoriasis who at baseline&#xD;
      begin systemically administered therapy vs: a) healthy controls; and b) patients with milder&#xD;
      psoriasis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">June 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Lipoprotein composition differences-glucose</measure>
    <time_frame>one year</time_frame>
    <description>To assess differences in the blood concentration levels at baseline for glucose in moderate-to-severe pediatric psoriasis at baseline who begin systemically administered therapy vs: a) healthy controls; and b) patients with milder psoriasis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lipoprotein composition differences-insulin</measure>
    <time_frame>one year</time_frame>
    <description>To assess differences in the blood concentration levels at baseline for insulin in moderate-to-severe pediatric psoriasis at baseline who begin systemically administered therapy vs: a) healthy controls; and b) patients with milder psoriasis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lipoprotein composition differences-c-reactive protein</measure>
    <time_frame>one year</time_frame>
    <description>To assess differences in the blood concentration levels at baseline for c-reactive protein in moderate-to-severe pediatric psoriasis at baseline who begin systemically administered therapy vs: a) healthy controls; and b) patients with milder psoriasis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lipoprotein composition differences-lipid concentration</measure>
    <time_frame>one year</time_frame>
    <description>To assess differences in the blood concentration levels at baseline for lipid concentration in moderate-to-severe pediatric psoriasis at baseline who begin systemically administered therapy vs: a) healthy controls; and b) patients with milder psoriasis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lipoprotein composition differences-chemistry panel</measure>
    <time_frame>one year</time_frame>
    <description>To assess differences in the blood concentration levels at baseline for chemistry panel in moderate-to-severe pediatric psoriasis at baseline who begin systemically administered therapy vs: a) healthy controls; and b) patients with milder psoriasis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lipoprotein composition differences-apolipoprotein</measure>
    <time_frame>one year</time_frame>
    <description>To assess differences in the blood concentration levels at baseline for apolipoprotein in moderate-to-severe pediatric psoriasis at baseline who begin systemically administered therapy vs: a) healthy controls; and b) patients with milder psoriasis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lipoprotein composition differences-NMR</measure>
    <time_frame>one year</time_frame>
    <description>To assess differences in the blood concentration levels at baseline for NMR derived lipoprotein particle concentrations in moderate-to-severe pediatric psoriasis at baseline who begin systemically administered therapy vs: a) healthy controls; and b) patients with milder psoriasis.</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Psoriasis</condition>
  <arm_group>
    <arm_group_label>Psoriasis patients to be treated only topically</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Psoriasis patients with moderate-to-severe psoriasis who begin</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Age-, sex- and BMI percentile-matched controls</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients being treated with isotretinoin for acne</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fasting blood draw for lipid assessments</intervention_name>
    <description>Fasting blood draw for lipid assessments</description>
    <arm_group_label>Age-, sex- and BMI percentile-matched controls</arm_group_label>
    <arm_group_label>Patients being treated with isotretinoin for acne</arm_group_label>
    <arm_group_label>Psoriasis patients to be treated only topically</arm_group_label>
    <arm_group_label>Psoriasis patients with moderate-to-severe psoriasis who begin</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples for lipids testing&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The investigators plan to recruit approximately 120 subjects total. Subjects will be&#xD;
        divided into 4 groups: i) patients to be treated only topically (n=30); ii) patients with&#xD;
        moderate-to-severe psoriasis who begin systemic treatment (n=30; ~15 DMARDs and 15&#xD;
        biologics); iii) age-, sex- and BMI percentile-matched controls (n=30); iv) patients being&#xD;
        treated with isotretinoin for acne (n=30).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children ages 6-17 years of all races/ethnicities with plaque and/or extensive guttate&#xD;
             psoriasis for at least 6 months and on topical or systemic therapy&#xD;
&#xD;
          -  Patients in the systemic group can be starting a medication for the first time OR&#xD;
             transitioning from another systemic if unresponsive and on that previous treatment for&#xD;
             ≤ 3 months.&#xD;
&#xD;
          -  Patients may concurrently have psoriatic arthritis if initiation of a systemic&#xD;
             medication is warranted by skin severity.&#xD;
&#xD;
          -  Children ages 6-17 years of all races/ethnicities with acne being treated with&#xD;
             isotretinoin&#xD;
&#xD;
          -  Children ages 6-17 years of all races/ethnicities without plaque or guttate psoriasis&#xD;
             and history of severe acne or treatment with isotretinoin as controls.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients less than 6 years of age or 18 years and older&#xD;
&#xD;
          -  Patients with congenital heart disease, prior cardiac catheterizations/surgeries, or&#xD;
             on cardiac medications in the past two years other than for hypertension (eg, calcium&#xD;
             channel-blockers, beta-blockers and vasotropic medications).&#xD;
&#xD;
          -  Patients who have other systemic inflammatory diseases (including atopic dermatitis,&#xD;
             severe acne, inflammatory bowel disease, juvenile idiopathic arthritis, connective&#xD;
             tissue diseases and/or other autoimmune diseases).&#xD;
&#xD;
          -  Patients who have active infection or malignancy or have suffered from infection&#xD;
             requiring oral or parenteral antibiotic in past 2 weeks.&#xD;
&#xD;
          -  Patients and parents/caregivers unable to give written informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amy Paller, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>DermatologyCTU</last_name>
    <phone>312-503-5944</phone>
    <email>NUderm-research@northwestern.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ann &amp; Robert H. Lurie Children's Hospital of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>DermatologyCTU</last_name>
      <phone>312-503-5944</phone>
      <email>NUderm-research@northwestern.edu</email>
    </contact>
    <investigator>
      <last_name>Amy Paller, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 2019</study_first_posted>
  <last_update_submitted>April 4, 2023</last_update_submitted>
  <last_update_submitted_qc>April 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Amy Paller</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </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/NCT03791216
org study id: 2019-2361
nct id: NCT03791216
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will assess differences in inflammatory proteins, lipoprotein composition,
      cholesterol efflux and HDL-proteome in moderate-to-severe pediatric psoriasis who at baseline
      begin systemically administered therapy vs: a) healthy controls; and b) patients with milder
      psoriasis.
observational model: Case-Control
time perspective: Prospective
measure: Lipoprotein composition differences-glucose
time frame: one year
description: To assess differences in the blood concentration levels at baseline for glucose in moderate-to-severe pediatric psoriasis at baseline who begin systemically administered therapy vs: a) healthy controls; and b) patients with milder psoriasis.
measure: Lipoprotein composition differences-insulin
time frame: one year
description: To assess differences in the blood concentration levels at baseline for insulin in moderate-to-severe pediatric psoriasis at baseline who begin systemically administered therapy vs: a) healthy controls; and b) patients with milder psoriasis.
measure: Lipoprotein composition differences-c-reactive protein
time frame: one year
description: To assess differences in the blood concentration levels at baseline for c-reactive protein in moderate-to-severe pediatric psoriasis at baseline who begin systemically administered therapy vs: a) healthy controls; and b) patients with milder psoriasis.
measure: Lipoprotein composition differences-lipid concentration
time frame: one year
description: To assess differences in the blood concentration levels at baseline for lipid concentration in moderate-to-severe pediatric psoriasis at baseline who begin systemically administered therapy vs: a) healthy controls; and b) patients with milder psoriasis.
measure: Lipoprotein composition differences-chemistry panel
time frame: one year
description: To assess differences in the blood concentration levels at baseline for chemistry panel in moderate-to-severe pediatric psoriasis at baseline who begin systemically administered therapy vs: a) healthy controls; and b) patients with milder psoriasis.
measure: Lipoprotein composition differences-apolipoprotein
time frame: one year
description: To assess differences in the blood concentration levels at baseline for apolipoprotein in moderate-to-severe pediatric psoriasis at baseline who begin systemically administered therapy vs: a) healthy controls; and b) patients with milder psoriasis.
measure: Lipoprotein composition differences-NMR
time frame: one year
description: To assess differences in the blood concentration levels at baseline for NMR derived lipoprotein particle concentrations in moderate-to-severe pediatric psoriasis at baseline who begin systemically administered therapy vs: a) healthy controls; and b) patients with milder psoriasis.
arm group label: Psoriasis patients to be treated only topically
arm group label: Psoriasis patients with moderate-to-severe psoriasis who begin
arm group label: Age-, sex- and BMI percentile-matched controls
arm group label: Patients being treated with isotretinoin for acne
intervention type: Other
intervention name: Fasting blood draw for lipid assessments
description: Fasting blood draw for lipid assessments
arm group label: Age-, sex- and BMI percentile-matched controls
arm group label: Patients being treated with isotretinoin for acne
arm group label: Psoriasis patients to be treated only topically
arm group label: Psoriasis patients with moderate-to-severe psoriasis who begin
Blood samples for lipids testing
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Amy Paller, MD
role: Principal Investigator
affiliation: Northwestern University
last name: DermatologyCTU
phone: 312-503-5944
email: NUderm-research@northwestern.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Amy Paller
investigator title: Principal Investigator
mesh term: Psoriasis
sharing ipd: No