Psoriasis Vulgaris
Conditions
Keywords
psoriasis, photochemotherapy, atherosclerosis, metabolic syndrome, cardiovascular risk
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.
Interventions
RADIATIONPUVA
36 sessions of psoralen-ultraviolet A, divided as 3 sessions weekly
Sponsors
Cairo University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 |
| 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 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 |
Countries
Egypt
Outcome results
None listed