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Cardiovascular Risk Evaluation in Psoriasis Treated With Photochemotherapy

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ClinicalTrials.gov Identifier: NCT02990624
Recruitment Status : Completed
First Posted : December 13, 2016
Last Update Posted : December 13, 2016
Sponsor:
Information provided by (Responsible Party):
Vanessa Suzanne Galal Hafez, Cairo University

Tracking Information
First Submitted Date  ICMJE November 29, 2016
First Posted Date  ICMJE December 13, 2016
Last Update Posted Date December 13, 2016
Study Start Date  ICMJE April 2014
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2016)
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 ]
Comparison between both risk groups in the amount of change between baseline level and end of study level of oxidized low density lipoprotein
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2016)
  • 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 ]
    Comparison between both risk groups as regards the number of patients with metabolic syndrome
  • 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 ]
    Comparison between both risk groups in the amount of change between baseline level and EOS level of waist circumference
  • 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 ]
    Comparison between both risk groups in the amount of change between baseline level and EOS level of arterial blood pressure
  • 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 ]
    Comparison between both risk groups in the amount of change between baseline level and EOS level of blood sugar
  • 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 ]
    Comparison between both risk groups in the amount of change between baseline level and EOS level of serum lipids
  • 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) ]
    comparison of duplex arteriography findings in the high risk group between before and after treatment
  • 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 ]
    Correlation between PASI score after treatment and other parameters of systemic response (hs-CRP, ox-LDL, metabolic syndrome components)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cardiovascular Risk Evaluation in Psoriasis Treated With Photochemotherapy
Official Title  ICMJE Effect of Photochemotherapy on Cardiometabolic Markers in Patients With Psoriasis With and Without Atherosclerosis
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis Vulgaris
Intervention  ICMJE Radiation: PUVA
36 sessions of psoralen-ultraviolet A, divided as 3 sessions weekly
Study Arms  ICMJE
  • Active Comparator: High risk group
    Patients with psoriasis and atherosclerosis will receive PUVA therapy for 36 sessions divided as 3 sessions weekly
    Intervention: Radiation: PUVA
  • Active Comparator: Low risk group
    Patients with psoriasis but no atherosclerosis detected, will receive PUVA therapy for 36 sessions divided as 3 sessions weekly
    Intervention: Radiation: PUVA
  • No Intervention: Control group
    Age-matching apparently normal individuals will receive no interventions but will perform investigational tests.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 8, 2016)
65
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Disease affecting > 10% body surface area
  • Patient willing to commit to 3 sessions weekly for 3-6 months without interruption

Exclusion Criteria:

  • Disease severity less than 10% body surface area
  • Patients unable to commit for therapeutic schedule due to work or residence issues.
  • pregnant and lactating females
  • photosensitive dermatoses
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02990624
Other Study ID Numbers  ICMJE CVR in UV phototherapy
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Vanessa Suzanne Galal Hafez, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cairo University
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP