Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cardiovascular Risk Evaluation in Psoriasis Treated With Photochemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Psoriasis Vulgaris Radiation: PUVA Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Photochemotherapy on Cardiometabolic Markers in Patients With Psoriasis With and Without Atherosclerosis
Study Start Date : April 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: High risk group
Patients with psoriasis and atherosclerosis will receive PUVA therapy for 36 sessions divided as 3 sessions weekly
Radiation: PUVA
36 sessions of psoralen-ultraviolet A, divided as 3 sessions weekly

Active Comparator: Low risk group
Patients with psoriasis but no atherosclerosis detected, will receive PUVA therapy for 36 sessions divided as 3 sessions weekly
Radiation: PUVA
36 sessions of psoralen-ultraviolet A, divided as 3 sessions weekly

No Intervention: Control group
Age-matching apparently normal individuals will receive no interventions but will perform investigational tests.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02990624


Locations
Layout table for location information
Egypt
Dermatology department - faculty of medicine- Cairo University
Cairo, Egypt
Sponsors and Collaborators
Cairo University
Layout table for additonal information
Responsible Party: Vanessa Suzanne Galal Hafez, Lecturer of dermatology, Cairo University
ClinicalTrials.gov Identifier: NCT02990624    
Other Study ID Numbers: CVR in UV phototherapy
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: December 13, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Vanessa Suzanne Galal Hafez, Cairo University:
psoriasis
photochemotherapy
atherosclerosis
metabolic syndrome
cardiovascular risk
Additional relevant MeSH terms:
Layout table for MeSH terms
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases