Cardiovascular Risk Evaluation in Psoriasis Treated With Photochemotherapy

Not Applicable

Completed

• Conditions: Psoriasis Vulgaris
• Interventions: Radiation: PUVA

• Registration Number: NCT02990624
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Primary Completion: 2015-09
• Study Completion: 2015-10
• Study First Submitted: 2016-11-29
• Status Verified: 2016-12
• Study First Submitted QC: 2016-12-08
• Last Update Submitted: 2016-12-08
• Study First Posted: 2016-12-13
• Last Update Posted: 2016-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High risk group	PUVA	Patients with psoriasis and atherosclerosis will receive PUVA therapy for 36 sessions divided as 3 sessions weekly
Low risk group	PUVA	Patients with psoriasis but no atherosclerosis detected, will receive PUVA therapy for 36 sessions divided as 3 sessions weekly

Primary Outcome Measures

Name	Time	Method
Comparative change in photoinduced oxidation and related change in cardiovascular risk between both risk groups in response to photochemotherapy	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

Name	Time	Method
Atherosclerotic changes in the high risk group in response to PUVA	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	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)
comparative number of patients with metabolic syndrome after therapy in both groups	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	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 3: 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	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 2: 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	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 4: 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	Comparison between both risk groups in the amount of change between baseline level and EOS level of serum lipids

Trial Locations

Locations (1)

Dermatology department - faculty of medicine- Cairo University; 🇪🇬 Cairo, Egypt