Cardiovascular Risk Evaluation in Psoriasis Treated With Photochemotherapy

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Photochemotherapy on Cardiometabolic Markers in Patients With Psoriasis With and Without Atherosclerosis

Conditions
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Psoriasis Vulgaris

Intervention / Treatment
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* Radiation: PUVA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High risk group<br>Patients with psoriasis and atherosclerosis will receive PUVA therapy for 36 sessions divided as 3 sessions weekly | Radiation: PUVA<br>* 36 sessions of psoralen-ultraviolet A, divided as 3 sessions weekly<br>|
| Active Comparator: Low risk group<br>Patients with psoriasis but no atherosclerosis detected, will receive PUVA therapy for 36 sessions divided as 3 sessions weekly | Radiation: PUVA<br>* 36 sessions of psoralen-ultraviolet A, divided as 3 sessions weekly<br>|
| No Intervention: Control group<br>Age-matching apparently normal individuals will receive no interventions but will perform investigational tests. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | end of 12 weeks (end of 36 sessions, 3 sessions weekly of photochemotherapy) and/or clinical cure whichever comes first | 
| 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 | day 0 to end of 12 weeks (end of 36 sessions, 3 sessions weekly of photochemotherapy) and/or clinical cure whichever comes first | 
| 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 | day 0 to end of 12 weeks (end of 36 sessions, 3 sessions weekly of photochemotherapy) and/or clinical cure whichever comes first | 
| 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 | day 0 to end of 12 weeks (end of 36 sessions, 3 sessions weekly of photochemotherapy) and/or clinical cure whichever comes first | 
| 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 | day 0 to end of 12 weeks (end of 36 sessions, 3 sessions weekly of photochemotherapy) and/or clinical cure whichever comes first | 
| 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 | end of 12 weeks (end of 36 sessions, 3 sessions weekly of photochemotherapy) | 
| 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) | day 0 to end of 12 weeks (end of 36 sessions, 3 sessions weekly of photochemotherapy) and/or clinical cure whichever comes first | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psoriasis, photochemotherapy, atherosclerosis, metabolic syndrome, cardiovascular risk