<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/NCT02193919</url>
  </required_header>
  <id_info>
    <org_study_id>PO-001</org_study_id>
    <nct_id>NCT02193919</nct_id>
  </id_info>
  <brief_title>A Single-Center, Prospective, Pilot Study to Compare the Effect of Diet in Overweight or Obese Patients With Psoriasis on Light Therapy</brief_title>
  <official_title>A Single-Center, Prospective, Single-Blind, Pilot Study to Compare the Effect of Diet in Overweight or Obese Patients With Psoriasis on Light Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bagel, Jerry, M.D.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bagel, Jerry, M.D.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Weight loss may help psoriasis. Phototherapy helps psoriasis. Combining the two treatments&#xD;
      may help even more. Determining if a high protein diet vs a low protein diet results in&#xD;
      improving psoriais may help lead to future dietary effects on psoriasis therapy&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2007</start_date>
  <completion_date type="Actual">May 2008</completion_date>
  <primary_completion_date type="Actual">May 2008</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Does weight decrease the amount of UVB needed to clear psoriasis</measure>
    <time_frame>12 weeks</time_frame>
    <description>3 cohorts, all get UVB thrice per week one cohort placebo diet one cohort south beach diet one cohort ornish diet I evaluated PASI 75 improvement within each cohort 0 Adverse Events</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Psoriasis</condition>
  <arm_group>
    <arm_group_label>cohort 1 placebo + UVB</arm_group_label>
    <description>cohort 1 placebo + UVB</description>
  </arm_group>
  <arm_group>
    <arm_group_label>South Beach Diet + UVB</arm_group_label>
    <description>South Beach DIet + UVB</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ornish Diet + UVB</arm_group_label>
    <description>Ornish Diet + UVB</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        30 patients, males, females, over 18 yo with moderate-to-severe psoriasis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  PSA greater 10&#xD;
&#xD;
          -  BMI greater than 30&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  PSA less than 10&#xD;
&#xD;
          -  less than 18 years old&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jerry Bagel</last_name>
    <role>Principal Investigator</role>
    <affiliation>Psoriasis Treatment Center of Central New Jersey</affiliation>
  </overall_official>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>February 4, 2013</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>July 16, 2014</last_update_submitted>
  <last_update_submitted_qc>July 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bagel, Jerry, M.D.</investigator_affiliation>
    <investigator_full_name>Jerry Bagel MD</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <keyword>psoriasis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <!-- 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/NCT02193919
org study id: PO-001
nct id: NCT02193919
lead sponsor: 
has dmc: No
Weight loss may help psoriasis. Phototherapy helps psoriasis. Combining the two treatments
      may help even more. Determining if a high protein diet vs a low protein diet results in
      improving psoriais may help lead to future dietary effects on psoriasis therapy
observational model: Cohort
time perspective: Prospective
measure: Does weight decrease the amount of UVB needed to clear psoriasis
time frame: 12 weeks
description: 3 cohorts, all get UVB thrice per week one cohort placebo diet one cohort south beach diet one cohort ornish diet I evaluated PASI 75 improvement within each cohort 0 Adverse Events
arm group label: cohort 1 placebo + UVB
description: cohort 1 placebo + UVB
arm group label: South Beach Diet + UVB
description: South Beach DIet + UVB
arm group label: Ornish Diet + UVB
description: Ornish Diet + UVB
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jerry Bagel
role: Principal Investigator
affiliation: Psoriasis Treatment Center of Central New Jersey
responsible party type: Principal Investigator
investigator affiliation: Bagel, Jerry, M.D.
investigator full name: Jerry Bagel MD
investigator title: Director
mesh term: Psoriasis
mesh term: Overweight