Ustekinumab Plus UVB-311nm Half-side Phototherapy in Patients With Psoriasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Modified PASI (psoriasis area and severity index)
研究概览
简要总结
Ustekinumab, an IL-12/23 antibody has been approved in the E.C. and U.S.A. for the treatment of moderate to severe psoriasis. The aim of this study is to determine in a randomized half-side comparison whether additional narrowband UVB-311nm phototherapy accelerates and improves the clearance of skin lesions in Ustekinumab-treated patients.
详细描述
Patients with moderate to severe psoriasis who receive standard treatment with Ustekinumab (45 mg at week 0, 4, and every 12 weeks) are exposed to UVB-311nm phototherapy on a randomized body half (left or right; head exempt) 3 x per week for six weeks and/or until complete response (defined as reduction in PASI to < 3). PASI score, patient visual analogue score (VAS) for therapeutic response, and patient VAS for severity of skin lesions is assessed weekly; and at follow-up visits at month 3, 6, and 12. Paired Wilcoxon testing for differences in PASI and patient VAS scores is done; Fischer exact test is applied to determine differences in complete remission, PASI reduction > 90%, > 75% and/or 50% between body sites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Psoriasis patients who receive treatment with Ustekinumab
排除标准
- •Age below 18 years
- •Pregnancy or lactation
- •History of malignant melanoma
- •History of invasive squamous cell carcinoma of the skin
- •Dysplastic melanocytic nevus syndrome
- •Antinuclear antibodies (ds-DNA, Ro/SSA, La/SSB)
- •Autoimmune disorders such as Lupus erythematosus or Dermatomyositis
- •Photosensitive diseases such as porphyria, chronic actinic dermatitis, Xeroderma pigmentosum, basal cell nevus syndrome, and others
- •General poor health status
结局指标
主要结局
Modified PASI (psoriasis area and severity index)
时间窗: 12 months
次要结局
- Patient visual analogue (VAS) score for therapeutic effect and severity of skin lesions(12 months)
研究者
Peter Wolf, MD
Professor of Bioimmunotherapy
Medical University of Graz