Fumaric Acid Esters Versus Fumaric Acid Esters Plus Narrow Band Type B Ultraviolet (UVB) in Patients With Severe Plaque Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Mean reduction in Psoriasis Area and Severity Index (PASI)
研究概览
简要总结
The main objective of the study is to evaluate the additional effect of a narrow band Type B Ultraviolet (UVB) therapy on the treatment of severe plaque psoriasis with fumaric acid esters (FAE) in comparison to FAE monotherapy. The secondary objectives are to evaluate the effect of an additional narrow band UVB therapy on the cumulative FAE dose required to reach Psoriasis Area and Severity Index (PASI) 75 in comparison to FAE monotherapy and to evaluate whether a leukopenia and lymphopenia frequently occurring during the FAE treatment is a positive predictive factor for the treatment response.
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 (Investigator)
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
- •Patient with moderately severe to severe Psoriasis (BSA ≥ 10 and PASI ≥ 10)
- •Age between 18 and 80 years old
排除标准
- •pregnant woman and satisfying women
- •cancer, chronic infections, autoimmune diseases
- •gastrointestinal illnesses
- •liver diseases
- •renal malfunctions
研究组 & 干预措施
Fumaric acid esters
Fumaric acid esters monotherapy
干预措施: Fumaric acid esters (Drug)
fumaric acid esters plus narrow band UVB
Combination therapy of fumaric acid esters plus narrow band type B ultraviolet therapy (UVB)
干预措施: Full Body UV Therapy System UV 7002 plus fumaric acid esters (Device)
结局指标
主要结局
Mean reduction in Psoriasis Area and Severity Index (PASI)
时间窗: Baseline and 6 weeks
次要结局
- Mean reduction in Psoriasis Log-based Area and Severity Index (PLASI)(Baseline and 6 months)
- Mean reduction in Dermatology Life Quality INDEX (DLQI)(Baseline and 6 months)
- Mean white blood cells (Leukocytes and Lymphocytes) count(Baseline and 6 months)
- Mean cumulative FAE dose required to reach PASI 75(6 months)
- Mean reduction in Psoriasis Area and Severity Index (PASI)(Baseline and 6 months)
研究者
Adrian Tanew
MD
Medical University of Vienna