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临床试验/NCT01402414
NCT01402414终止不适用

Study Comparing the Effectiveness of Narrow-band UVB vs. Bath-PUVA and Narrow-band UVB + Salt Water Baths in Atopic Dermatitis

Ruhr University of Bochum2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2011年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
10
试验地点
2
主要终点
Clinical improvement after treatments using a validated SASSAD index

研究概览

简要总结

In this controlled crossover study we aim to compare the efficacy of narrow-band UVB (NB-UVB) with bath-PUVA and NB-UVB plus salt water baths in atopic dermatitis.

详细描述

Atopic dermatitis (AD) is a very common skin disorder that is characterized by pruritic inflammatory skin lesions, with patients usually having an individual or family history of atopic diseases in their background (e.g., allergic asthma and rhinitis). Defective skin barrier, immunological dysfunctions (type I and IV allergy), genetic disorders, and psychological factors contribute to the pathogenesis of AD. However, among these factors, CD4+ Th cells are reported to play a particularly crucial role in the pathogenesis of AD. Phototherapy is among the first-line approaches in the management of AD. In this context, a variety of studies have shown a beneficial effect of natural or artificial UV radiation in AD. Different broadband (BB) UV spectra (BB-UVA, BB-UVB, BB-UVA/BB-UVB) and combined treatment modalities such as balneophototherapy and PUVA have previously been proven to be effective in AD. A small controlled study has previously demonstrated that the combination of UVB/UVA and saltwater baths is superior to phototherapy alone. Previous data from uncontrolled studies also speak for the effectiveness of systemic psoralen plus UVA (PUVA) therapy. A controlled crossover study has shown that systemic PUVA therapy is clearly superior to UVA1 phototherapy both in terms of clinical score (SCORAD) and reduction of response time. Systemic PUVA has in relation to bath PUVA significantly greater adverse effects (eg, nausea, liver enzyme elevation, photocarcinogenesis). A direct comparison between NB-UVB and bath PUVA has only been studied by a half-side comparison in a small number of patients. Both therapies were proved equally effective. In a recent study, it has been shown a clear advantage of NB-UVB plus salt water baths in comparison to NB-UVB alone. Tolerability was comparable; both treatments showed to be safe.

A randomized observer-blinded controlled crossover trial is conducted in which patients with AD receive a 4-week course of both NB-UVB and bath-PUVA or NB-UVB plus salt water baths. Clinical efficacy is assessed using the Six Area, Six Sign, Atopic Dermatitis (SASSAD) score and a visual analogue scale for pruritus. Assessment of health-related quality of life was performed using the Skindex-29. Moreover, immunohistochemical, RT-PCR and serological studies are planned.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with moderate to severe disease AD with SASSAD-Score > 25
  • Age > 18 years
  • No topical steroids or topical/systemic antibiotics within the last 2 weeks, no systemic glucocorticosteroids or other immunosuppressive agents within the last 8 weeks, no phototherapy within the last 12 weeks before inclusion

排除标准

  • Pregnancy or lactation
  • Skin cancer or dysplastic naevi, photosensitive skin diseases, autoimmune diseases or relevant cardiovascular diseases
  • Photo-skin type I according to Fitzpatrick
  • severe cardiovascular disease
  • intense UV radiation (tanning beds, sun exposure, phototherapy, etc.) 8 weeks before the start of the study

结局指标

主要结局

Clinical improvement after treatments using a validated SASSAD index

时间窗: Evaluation at baseline and after 4-week treatment, 3 months follow-up

Clinical improvement after treatments using a validated SASSAD index

次要结局

  • Evaluation of pruritus and sleeplessness visual analogue scales(Evaluation at baseline and after 4-week treatment, 3 months follow-up)
  • Measuring quality of life using the Skindex-29(Evaluation at baseline and after 4-week treatment, 3 months follow-up)
  • Immunohistochemical, RT-PCR and serological parameters(Evaluation at baseline and after 4-week treatment)

研究者

发起方
Ruhr University of Bochum
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sarah Terras

Thilo Gambichler, Professor, Ruhr University Bochum

Ruhr University of Bochum

研究点 (2)

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