Clinical trial NCT02990624: 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
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis Vulgaris
Keywords: psoriasis
photochemotherapy
atherosclerosis
metabolic syndrome
cardiovascular risk
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-12-13
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Comparative change in photoinduced oxidation and related change in cardiovascular risk between both risk groups in response to photochemotherapy
timeFrame: day 0 to end of 12 weeks (end of 36 sessions, 3 sessions weekly of photochemotherapy) and/or clinical cure whichever comes first
Secondary outcomes:
measure: comparative number of patients with metabolic syndrome after therapy in both groups
timeFrame: end of 12 weeks (end of 36 sessions, 3 sessions weekly of photochemotherapy) and/or clinical cure whichever comes first
measure: Comparative changes in metabolic syndrome component 1: waist circumference
timeFrame: day 0 to end of 12 weeks (end of 36 sessions, 3 sessions weekly of photochemotherapy) and/or clinical cure whichever comes first
measure: Comparative changes in metabolic syndrome component 2: arterial blood pressure
timeFrame: day 0 to end of 12 weeks (end of 36 sessions, 3 sessions weekly of photochemotherapy) and/or clinical cure whichever comes first
measure: Comparative changes in metabolic syndrome component 3: blood sugar
timeFrame: day 0 to end of 12 weeks (end of 36 sessions, 3 sessions weekly of photochemotherapy) and/or clinical cure whichever comes first
measure: Comparative changes in metabolic syndrome component 4: serum lipids
timeFrame: day 0 to end of 12 weeks (end of 36 sessions, 3 sessions weekly of photochemotherapy) and/or clinical cure whichever comes first
measure: Atherosclerotic changes in the high risk group in response to PUVA
timeFrame: end of 12 weeks (end of 36 sessions, 3 sessions weekly of photochemotherapy)
measure: Correlation between cutaneous response and systemic response to photochemotherapy in both risk groups
timeFrame: day 0 to end of 12 weeks (end of 36 sessions, 3 sessions weekly of photochemotherapy) and/or clinical cure whichever comes first
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Dermatology department - faculty of medicine- Cairo University
Study officials:
References: