Cardiovascular Risk Evaluation in Psoriasis Treated With Photochemotherapy

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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis Vulgaris
• Intervention / Treatment: Radiation: PUVA

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Dermatology department - faculty of medicine- Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: November 29, 2016
• First Submitted That Met QC Criteria: December 8, 2016
• First Posted (Estimate): December 13, 2016

Study Record Updates

• Last Update Posted (Estimate): December 13, 2016
• Last Update Submitted That Met QC Criteria: December 8, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: cardiovascular risk; atherosclerosis; metabolic syndrome; psoriasis; photochemotherapy
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: CVR in UV phototherapy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO