<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/NCT01714284</url>
  </required_header>
  <id_info>
    <org_study_id>PSODIET1</org_study_id>
    <nct_id>NCT01714284</nct_id>
  </id_info>
  <brief_title>Efficacy Study of Dietary Intervention and Weight Loss in Improving Psoriasis</brief_title>
  <official_title>Multicenter Randomized Clinical Study Evaluating the Efficacy of Dietary Intervention and Weight Loss in Improving Psoriasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centro Studi Gised</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Azienda Ospedaliero-Universitaria di Modena</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centro Studi Gised</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multicenter randomized controlled clinical trial evaluating the impact of a&#xD;
      structured non pharmacological intervention consisting in intensive weight reduction&#xD;
      (qualitative and quantitative changes in diet associated with physical exercise) compared to&#xD;
      an intervention based on a simple informative counseling about the utility of weight loss for&#xD;
      clinical control of psoriatic disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2011</start_date>
  <completion_date type="Actual">January 2012</completion_date>
  <primary_completion_date type="Actual">January 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Any change from baseline of PASI index</measure>
    <time_frame>20 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent change from baseline of PASI index equal to or greater than 50% (PASI50+)</measure>
    <time_frame>8 weeks, 16 weeks, 20 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent change from baseline of PASI index equal to 100% (PASI100)</measure>
    <time_frame>8 weeks, 16 weeks, 20 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Any change from baseline of PASI index</measure>
    <time_frame>8 weeks, 16 weeks, 20 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Any reduction from baseline of Body Mass Index (BMI)</measure>
    <time_frame>8 weeks, 16 weeks, 20 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Any reduction from baseline of waist circumference</measure>
    <time_frame>8 weeks, 16 weeks, 20 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent change from baseline of PASI index equal to or greater than 75% (PASI75+)</measure>
    <time_frame>8 weeks, 16 weeks, 20 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">303</enrollment>
  <condition>Psoriasis</condition>
  <arm_group>
    <arm_group_label>Diet and Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Informative</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Informative</intervention_name>
    <description>The intervention consists in a simple informative counseling about the utility of weight loss for clinical control of psoriatic disease.</description>
    <arm_group_label>Informative</arm_group_label>
    <other_name>informative, weight loss</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Diet and Exercise</intervention_name>
    <description>The intervention consists in a 20 weeks quantitative and qualitative dietary plan for weight loss associated with physical exercise. The plan will be developed with the help of qualified staff (Dieticians) and elaborated in relation to individual needs of the patient.</description>
    <arm_group_label>Diet and Exercise</arm_group_label>
    <other_name>diet, weight loss, exercise</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of chronic plaque psoriasis&#xD;
&#xD;
          -  BMI &gt; 25 Kg/m²&#xD;
&#xD;
          -  Patients under systemic treatments for psoriasis or candidates for such treatments&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of other type of psoriasis or psoriatic arthritis&#xD;
&#xD;
          -  Patients under local treatments or candidates for such treatments&#xD;
&#xD;
          -  Patients expected to have poor compliance at follow-up evaluation&#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_official>
    <last_name>Luigi Naldi, MD</last_name>
    <role>Study Director</role>
    <affiliation>Centro Studi Gised</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alberto Giannetti, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University General Hospital of Modena</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Dermatology; Bellaria-Maggiore Hospital</name>
      <address>
        <city>Bologna</city>
        <state>Emilia Romagna</state>
        <zip>40133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Dermatology; S.Orsola-Malpighi General Hospital</name>
      <address>
        <city>Bologna</city>
        <state>Emilia Romagna</state>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatology Department; M. Bufalini Hospital</name>
      <address>
        <city>Cesena</city>
        <state>Emilia Romagna</state>
        <zip>47521</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Dermatology; S. Anna University Hospital</name>
      <address>
        <city>Ferrara</city>
        <state>Emilia Romagna</state>
        <zip>44124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Dermatology; G.B.Morgagni-L.Pierantoni Hospital</name>
      <address>
        <city>Forlì</city>
        <state>Emilia Romagna</state>
        <zip>47121</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Dermatology; University General Hospital of Modena</name>
      <address>
        <city>Modena</city>
        <state>Emilia Romagna</state>
        <zip>41124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Dermatology; University General Hospital of Parma</name>
      <address>
        <city>Parma</city>
        <state>Emilia Romagna</state>
        <zip>43126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Dermatology; Hospital of Piacenza</name>
      <address>
        <city>Piacenza</city>
        <state>Emilia Romagna</state>
        <zip>29121</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Dermatology; AUSL of Ravenna</name>
      <address>
        <city>Ravenna</city>
        <state>Emilia Romagna</state>
        <zip>48121</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Dermatology; S. Maria Nuova Hospital</name>
      <address>
        <city>Reggio Emilia</city>
        <state>Emilia Romagna</state>
        <zip>42123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Dermatology; Infermi Hospital</name>
      <address>
        <city>Rimini</city>
        <state>Emilia Romagna</state>
        <zip>47900</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>February 2013</verification_date>
  <study_first_submitted>October 23, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 25, 2012</study_first_posted>
  <last_update_submitted>February 21, 2013</last_update_submitted>
  <last_update_submitted_qc>February 21, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 22, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>Weight Loss</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/NCT01714284
org study id: PSODIET1
nct id: NCT01714284
lead sponsor: 
collaborator: 
has dmc: No
This is a multicenter randomized controlled clinical trial evaluating the impact of a
      structured non pharmacological intervention consisting in intensive weight reduction
      (qualitative and quantitative changes in diet associated with physical exercise) compared to
      an intervention based on a simple informative counseling about the utility of weight loss for
      clinical control of psoriatic disease.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Any change from baseline of PASI index
time frame: 20 weeks
measure: Percent change from baseline of PASI index equal to or greater than 50% (PASI50+)
time frame: 8 weeks, 16 weeks, 20 weeks
measure: Percent change from baseline of PASI index equal to 100% (PASI100)
time frame: 8 weeks, 16 weeks, 20 weeks
measure: Any change from baseline of PASI index
time frame: 8 weeks, 16 weeks, 20 weeks
measure: Any reduction from baseline of Body Mass Index (BMI)
time frame: 8 weeks, 16 weeks, 20 weeks
measure: Any reduction from baseline of waist circumference
time frame: 8 weeks, 16 weeks, 20 weeks
measure: Percent change from baseline of PASI index equal to or greater than 75% (PASI75+)
time frame: 8 weeks, 16 weeks, 20 weeks
arm group label: Diet and Exercise
arm group type: Experimental
arm group label: Informative
arm group type: Sham Comparator
intervention type: Behavioral
intervention name: Informative
description: The intervention consists in a simple informative counseling about the utility of weight loss for clinical control of psoriatic disease.
arm group label: Informative
other name: informative, weight loss
intervention type: Behavioral
intervention name: Diet and Exercise
description: The intervention consists in a 20 weeks quantitative and qualitative dietary plan for weight loss associated with physical exercise. The plan will be developed with the help of qualified staff (Dieticians) and elaborated in relation to individual needs of the patient.
arm group label: Diet and Exercise
other name: diet, weight loss, exercise
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Luigi Naldi, MD
role: Study Director
affiliation: Centro Studi Gised
last name: Alberto Giannetti, MD
role: Principal Investigator
affiliation: University General Hospital of Modena
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Psoriasis
mesh term: Weight Loss