跳至主要内容
临床试验/NCT01569906
NCT01569906已完成不适用

Narrowband Ultraviolet B Phototherapy in Children With Moderate to Severe Atopic Eczema- an Observational Prospective Controlled Study

Royal Victoria Infirmary1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2009年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
58
试验地点
1
主要终点
Score at the end of treatment compared to the control group

研究概览

简要总结

To assess prospectively, the response of moderate to severe atopic eczema to a standard course of narrowband ultraviolet B phototherapy by using validated objective and subjective scoring systems.

详细描述

Children with moderate to severe atopic eczema prescribed a course of narrowband UVB phototherapy were scored (using validated scoring systems) objectively and subjectively before, during and after the course of treatment, as well as 3 and 6 months post treatment (to determine length of remission). Their scores were compared to a control group. The control group comprised children with moderate to severe atopic eczema who were offered UVB but were unable to undertake the treatment.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
3 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 3-16 years with moderate to severe atopic eczema (as defined by the modified Hannifin and Rajka criteria) in whom there is a clinical indication for phototherapy (as deemed by their specialist Dermatology consultant).

排除标准

  • Children under the age of 3 years or any child who lacks the maturity needed to stand in the phototherapy cabinet unsupervised.
  • Mild disease (defined as a Six Area Six Sign Atopic Dermatitis (SASSAD) score <10)

结局指标

主要结局

Score at the end of treatment compared to the control group

时间窗: 12 weeks

Measurement of Six Area Six Sign Atopic Dermatitis (SASSAD) score and percentage surface area affected of those treated with narrowband UVB as compared to a control group

次要结局

  • Subjective scores at the end of treatment as compared to controls(12 weeks)
  • objective scores at 3 months post treatment compared to controls(3 months)
  • Association of filaggrin status with outcome(12 weeks)
  • Objective scores at 6 months post treatment compared to controls(6 months)
  • Subjective scores at 3 months post treatment compared to controls(3 months)
  • Subjective scores at 6 months post treatment compared to controls(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr AEM Taylor

Consultant Dermatologist

Royal Victoria Infirmary

研究点 (1)

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