NCT00512187已完成4 期
Moderate Weight Loss Makes Obese Patients With Severe Chronic Plaque Psoriasis Responsive to Sub-Optimal Dose of Cyclosporine: an Investigator Blinded, Controlled, Randomized Clinical Trial
Universita di Verona2 个研究点 分布在 1 个国家开始时间: 2005年11月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 试验地点
- 2
- 主要终点
- Primary end point PASI 75 response
研究概览
简要总结
The study hypothesis is to investigate whether a moderate weight loss (i.e. a weight reduction of at least 5%) could improve the response rate to a suboptimal dose of cyclosporine in patients with severe psoriasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age,active but clinically stable plaque psoriasis involving at least 10 percent of the body surface area and a psoriasis area and severity index (PASI) score ≥10 and a body mass index ≥30.
排除标准
- •Other type of psoriasis (guttate, erythrodermic and pustular psoriasis)
- •Uncontrolled hypertension
- •Severe congestive heart failure
- •Renal and liver impairment
- •Active or chronic infections, including HIV, HBV and HCV infections, latent tuberculosis
- •Previous or active malignancies
- •Pregnancy and lactations
- •Previous treatment with cyclosporine
- •Phototherapy or any systemic or topical therapy for psoriasis within the previous 4 weeks before enrolment.
结局指标
主要结局
Primary end point PASI 75 response
时间窗: week 24
次要结局
- secondary end point was % of body weight reduction(week 24)
研究者
研究点 (2)
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