Back to resultsCardiovascular Risk Evaluation in Psoriasis Treated With Photochemotherapy
Primary Purpose
Psoriasis Vulgaris
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
PUVA
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis Vulgaris focused on measuring psoriasis, photochemotherapy, atherosclerosis, metabolic syndrome, cardiovascular risk
Eligibility 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
Sites / Locations
- Dermatology department - faculty of medicine- Cairo University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
High risk group
Low risk group
Control group
Arm Description
Patients with psoriasis and atherosclerosis will receive PUVA therapy for 36 sessions divided as 3 sessions weekly
Patients with psoriasis but no atherosclerosis detected, will receive PUVA therapy for 36 sessions divided as 3 sessions weekly
Age-matching apparently normal individuals will receive no interventions but will perform investigational tests.
Outcomes
Primary Outcome Measures
Comparative change in photoinduced oxidation and related change in cardiovascular risk between both risk groups in response to photochemotherapy
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
comparative number of patients with metabolic syndrome after therapy in both groups
Comparison between both risk groups as regards the number of patients with metabolic syndrome
Comparative changes in metabolic syndrome component 1: waist circumference
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
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
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
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
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
Correlation between PASI score after treatment and other parameters of systemic response (hs-CRP, ox-LDL, metabolic syndrome components)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02990624
Brief Title
Cardiovascular Risk Evaluation in Psoriasis Treated With Photochemotherapy
Official Title
Effect of Photochemotherapy on Cardiometabolic Markers in Patients With Psoriasis With and Without Atherosclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris
Keywords
psoriasis, photochemotherapy, atherosclerosis, metabolic syndrome, cardiovascular risk
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High risk group
Arm Type
Active Comparator
Arm Description
Patients with psoriasis and atherosclerosis will receive PUVA therapy for 36 sessions divided as 3 sessions weekly
Arm Title
Low risk group
Arm Type
Active Comparator
Arm Description
Patients with psoriasis but no atherosclerosis detected, will receive PUVA therapy for 36 sessions divided as 3 sessions weekly
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Age-matching apparently normal individuals will receive no interventions but will perform investigational tests.
Intervention Type
Radiation
Intervention Name(s)
PUVA
Intervention Description
36 sessions of psoralen-ultraviolet A, divided as 3 sessions weekly
Primary Outcome Measure Information:
Title
Comparative change in photoinduced oxidation and related change in cardiovascular risk between both risk groups in response to photochemotherapy
Description
Comparison between both risk groups in the amount of change between baseline level and end of study level of oxidized low density lipoprotein
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
Secondary Outcome Measure Information:
Title
comparative number of patients with metabolic syndrome after therapy in both groups
Description
Comparison between both risk groups as regards the number of patients with metabolic syndrome
Time Frame
end of 12 weeks (end of 36 sessions, 3 sessions weekly of photochemotherapy) and/or clinical cure whichever comes first
Title
Comparative changes in metabolic syndrome component 1: waist circumference
Description
Comparison between both risk groups in the amount of change between baseline level and EOS level of 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
Title
Comparative changes in metabolic syndrome component 2: arterial blood pressure
Description
Comparison between both risk groups in the amount of change between baseline level and EOS level of 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
Title
Comparative changes in metabolic syndrome component 3: blood sugar
Description
Comparison between both risk groups in the amount of change between baseline level and EOS level of 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
Title
Comparative changes in metabolic syndrome component 4: serum lipids
Description
Comparison between both risk groups in the amount of change between baseline level and EOS level of 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
Title
Atherosclerotic changes in the high risk group in response to PUVA
Description
comparison of duplex arteriography findings in the high risk group between before and after treatment
Time Frame
end of 12 weeks (end of 36 sessions, 3 sessions weekly of photochemotherapy)
Title
Correlation between cutaneous response and systemic response to photochemotherapy in both risk groups
Description
Correlation between PASI score after treatment and other parameters of systemic response (hs-CRP, ox-LDL, metabolic syndrome components)
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Dermatology department - faculty of medicine- Cairo University
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cardiovascular Risk Evaluation in Psoriasis Treated With Photochemotherapy
We'll reach out to this number within 24 hrs