Effect of Photochemotherapy on Cardiometabolic Markers in Patients With Psoriasis With and Without Atherosclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Comparative change in photoinduced oxidation and related change in cardiovascular risk between both risk groups in response to photochemotherapy
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Disease affecting > 10% body surface area
- •Patient willing to commit to 3 sessions weekly for 3-6 months without interruption
排除标准
- •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
结局指标
主要结局
Comparative change in photoinduced oxidation and related change in cardiovascular risk between both risk groups in response to photochemotherapy
时间窗: 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
次要结局
- Atherosclerotic changes in the high risk group in response to PUVA(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(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 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)
- 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)
- 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)
- 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)
- 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)
研究者
Vanessa Suzanne Galal Hafez
Lecturer of dermatology
Cairo University