<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/NCT02990624</url>
  </required_header>
  <id_info>
    <org_study_id>CVR in UV phototherapy</org_study_id>
    <nct_id>NCT02990624</nct_id>
  </id_info>
  <brief_title>Cardiovascular Risk Evaluation in Psoriasis Treated With Photochemotherapy</brief_title>
  <official_title>Effect of Photochemotherapy on Cardiometabolic Markers in Patients With Psoriasis With and Without Atherosclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ultraviolet (UV) phototherapy is a standard treatment for many inflammatory dermatological&#xD;
      diseases, including psoriasis. The systemic effects of UV phototherapy are still not well&#xD;
      studied. There are several factors that may affect patient's cardiovascular (CV) risk during&#xD;
      UV phototherapy. Atherosclerosis is now known to have an inflammatory origin and to be&#xD;
      frequently associated with psoriasis. In this study the investigators aim at studying the&#xD;
      effect of psoralen-UVA phototherapy on several biomarkers of CV risk in patients with&#xD;
      psoriasis with or without atherosclerosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparative change in photoinduced oxidation and related change in cardiovascular risk between both risk groups in response to photochemotherapy</measure>
    <time_frame>day 0 to end of 12 weeks (end of 36 sessions, 3 sessions weekly of photochemotherapy) and/or clinical cure whichever comes first</time_frame>
    <description>Comparison between both risk groups in the amount of change between baseline level and end of study level of oxidized low density lipoprotein</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>comparative number of patients with metabolic syndrome after therapy in both groups</measure>
    <time_frame>end of 12 weeks (end of 36 sessions, 3 sessions weekly of photochemotherapy) and/or clinical cure whichever comes first</time_frame>
    <description>Comparison between both risk groups as regards the number of patients with metabolic syndrome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparative changes in metabolic syndrome component 1: waist circumference</measure>
    <time_frame>day 0 to end of 12 weeks (end of 36 sessions, 3 sessions weekly of photochemotherapy) and/or clinical cure whichever comes first</time_frame>
    <description>Comparison between both risk groups in the amount of change between baseline level and EOS level of waist circumference</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparative changes in metabolic syndrome component 2: arterial blood pressure</measure>
    <time_frame>day 0 to end of 12 weeks (end of 36 sessions, 3 sessions weekly of photochemotherapy) and/or clinical cure whichever comes first</time_frame>
    <description>Comparison between both risk groups in the amount of change between baseline level and EOS level of arterial blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparative changes in metabolic syndrome component 3: blood sugar</measure>
    <time_frame>day 0 to end of 12 weeks (end of 36 sessions, 3 sessions weekly of photochemotherapy) and/or clinical cure whichever comes first</time_frame>
    <description>Comparison between both risk groups in the amount of change between baseline level and EOS level of blood sugar</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparative changes in metabolic syndrome component 4: serum lipids</measure>
    <time_frame>day 0 to end of 12 weeks (end of 36 sessions, 3 sessions weekly of photochemotherapy) and/or clinical cure whichever comes first</time_frame>
    <description>Comparison between both risk groups in the amount of change between baseline level and EOS level of serum lipids</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Atherosclerotic changes in the high risk group in response to PUVA</measure>
    <time_frame>end of 12 weeks (end of 36 sessions, 3 sessions weekly of photochemotherapy)</time_frame>
    <description>comparison of duplex arteriography findings in the high risk group between before and after treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between cutaneous response and systemic response to photochemotherapy in both risk groups</measure>
    <time_frame>day 0 to end of 12 weeks (end of 36 sessions, 3 sessions weekly of photochemotherapy) and/or clinical cure whichever comes first</time_frame>
    <description>Correlation between PASI score after treatment and other parameters of systemic response (hs-CRP, ox-LDL, metabolic syndrome components)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">65</enrollment>
  <condition>Psoriasis Vulgaris</condition>
  <arm_group>
    <arm_group_label>High risk group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with psoriasis and atherosclerosis will receive PUVA therapy for 36 sessions divided as 3 sessions weekly</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low risk group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with psoriasis but no atherosclerosis detected, will receive PUVA therapy for 36 sessions divided as 3 sessions weekly</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Age-matching apparently normal individuals will receive no interventions but will perform investigational tests.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>PUVA</intervention_name>
    <description>36 sessions of psoralen-ultraviolet A, divided as 3 sessions weekly</description>
    <arm_group_label>High risk group</arm_group_label>
    <arm_group_label>Low risk group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Disease affecting &gt; 10% body surface area&#xD;
&#xD;
          -  Patient willing to commit to 3 sessions weekly for 3-6 months without interruption&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Disease severity less than 10% body surface area&#xD;
&#xD;
          -  Patients unable to commit for therapeutic schedule due to work or residence issues.&#xD;
&#xD;
          -  pregnant and lactating females&#xD;
&#xD;
          -  photosensitive dermatoses&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dermatology department - faculty of medicine- Cairo University</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>December 8, 2016</last_update_submitted>
  <last_update_submitted_qc>December 8, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 13, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Vanessa Suzanne Galal Hafez</investigator_full_name>
    <investigator_title>Lecturer of dermatology</investigator_title>
  </responsible_party>
  <keyword>psoriasis</keyword>
  <keyword>photochemotherapy</keyword>
  <keyword>atherosclerosis</keyword>
  <keyword>metabolic syndrome</keyword>
  <keyword>cardiovascular risk</keyword>
  <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/NCT02990624
org study id: CVR in UV phototherapy
nct id: NCT02990624
lead sponsor: 
has dmc: Yes
Ultraviolet (UV) phototherapy is a standard treatment for many inflammatory dermatological
      diseases, including psoriasis. The systemic effects of UV phototherapy are still not well
      studied. There are several factors that may affect patient's cardiovascular (CV) risk during
      UV phototherapy. Atherosclerosis is now known to have an inflammatory origin and to be
      frequently associated with psoriasis. In this study the investigators aim at studying the
      effect of psoralen-UVA phototherapy on several biomarkers of CV risk in patients with
      psoriasis with or without atherosclerosis.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Comparative change in photoinduced oxidation and related change in cardiovascular risk between both risk groups in response to photochemotherapy
time frame: day 0 to end of 12 weeks (end of 36 sessions, 3 sessions weekly of photochemotherapy) and/or clinical cure whichever comes first
description: Comparison between both risk groups in the amount of change between baseline level and end of study level of oxidized low density lipoprotein
measure: comparative number of patients with metabolic syndrome after therapy in both groups
time frame: end of 12 weeks (end of 36 sessions, 3 sessions weekly of photochemotherapy) and/or clinical cure whichever comes first
description: Comparison between both risk groups as regards the number of patients with metabolic syndrome
measure: Comparative changes in metabolic syndrome component 1: waist circumference
time frame: day 0 to end of 12 weeks (end of 36 sessions, 3 sessions weekly of photochemotherapy) and/or clinical cure whichever comes first
description: Comparison between both risk groups in the amount of change between baseline level and EOS level of waist circumference
measure: Comparative changes in metabolic syndrome component 2: arterial blood pressure
time frame: day 0 to end of 12 weeks (end of 36 sessions, 3 sessions weekly of photochemotherapy) and/or clinical cure whichever comes first
description: Comparison between both risk groups in the amount of change between baseline level and EOS level of arterial blood pressure
measure: Comparative changes in metabolic syndrome component 3: blood sugar
time frame: day 0 to end of 12 weeks (end of 36 sessions, 3 sessions weekly of photochemotherapy) and/or clinical cure whichever comes first
description: Comparison between both risk groups in the amount of change between baseline level and EOS level of blood sugar
measure: Comparative changes in metabolic syndrome component 4: serum lipids
time frame: day 0 to end of 12 weeks (end of 36 sessions, 3 sessions weekly of photochemotherapy) and/or clinical cure whichever comes first
description: Comparison between both risk groups in the amount of change between baseline level and EOS level of serum lipids
measure: Atherosclerotic changes in the high risk group in response to PUVA
time frame: end of 12 weeks (end of 36 sessions, 3 sessions weekly of photochemotherapy)
description: comparison of duplex arteriography findings in the high risk group between before and after treatment
measure: Correlation between cutaneous response and systemic response to photochemotherapy in both risk groups
time frame: day 0 to end of 12 weeks (end of 36 sessions, 3 sessions weekly of photochemotherapy) and/or clinical cure whichever comes first
description: Correlation between PASI score after treatment and other parameters of systemic response (hs-CRP, ox-LDL, metabolic syndrome components)
arm group label: High risk group
arm group type: Active Comparator
description: Patients with psoriasis and atherosclerosis will receive PUVA therapy for 36 sessions divided as 3 sessions weekly
arm group label: Low risk group
arm group type: Active Comparator
description: Patients with psoriasis but no atherosclerosis detected, will receive PUVA therapy for 36 sessions divided as 3 sessions weekly
arm group label: Control group
arm group type: No Intervention
description: Age-matching apparently normal individuals will receive no interventions but will perform investigational tests.
intervention type: Radiation
intervention name: PUVA
description: 36 sessions of psoralen-ultraviolet A, divided as 3 sessions weekly
arm group label: High risk group
arm group label: Low risk group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Vanessa Suzanne Galal Hafez
investigator title: Lecturer of dermatology
mesh term: Psoriasis
sharing ipd: No