Cardiovascular Risk Evaluation in Psoriasis Treated With Photochemotherapy

Psoriasis Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02990624
• Other study ID #: CVR in UV phototherapy
• Status: Completed
• Phase: N/A
• First received: November 29, 2016
• Last updated: December 8, 2016
• Start date: April 2014
• Est. completion date: October 2015

Study information

• Verified date: December 2016
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Psoriasis
• Psoriasis Vulgaris

Intervention

Radiation:
• PUVA
36 sessions of psoralen-ultraviolet A, divided as 3 sessions weekly

Locations

Country	Name	City	State
Egypt	Dermatology department - faculty of medicine- Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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)
Secondary	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	No