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临床试验/NCT03160053
NCT03160053已完成不适用

Improving Keloids Using Targeted Ultraviolet-B Irradiation

Johns Hopkins University0 个研究点目标入组 2 人开始时间: 2015年6月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
2
主要终点
Clinical Appearance As Assessed by the Patient and Observer Scar Assessment (POSAS) Scale

研究概览

简要总结

Treatment of keloids with targeted Ultraviolet-Beta (UVB) radiation will improve the clinical appearance and induration of lesions.

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
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

入选标准

  • Participants must be 18 years old or over
  • Participants must have a diagnosis of keloid
  • No treatment with topical or intralesional steroids for 1 month prior to study

排除标准

  • Patients who are unable to provide informed consent
  • A history of photosensitivity, lupus erythematosus, porphyria or current use of a known photosensitizing drug
  • Unwillingness to stop with topical or intralesional steroids for 1 month prior to study
  • A history of malignant melanoma
  • A history of radiation therapy to area of interest
  • Subjects who self-report that they are pregnant or nursing

研究组 & 干预措施

Control Group

No Intervention

Keloids that were randomized to a non treatment group, were not exposed to the NB-UVB light.

Treatment Group

Experimental

Keloids that were randomized to the treatment group, were exposed to Narrowband-UVB (NB-UVB). Targeted UVB will be delivered to the keloid for up to 16 weeks using the Lumera UVB light phototherapy device (Daavlin, Bryan Ohio, USA).The affected skin will be irradiated using a hand-held fiber optic cable with an adjustable aperture.

干预措施: NB-UVB (Device)

结局指标

主要结局

Clinical Appearance As Assessed by the Patient and Observer Scar Assessment (POSAS) Scale

时间窗: 16 weeks

Investigators will evaluate the pre- and post-study clinical photographs of all participants. The grading investigator will grade the degree of improvement using the POSAS scale to measure the clinical appearance of the keloids

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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