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临床试验/NCT00814918
NCT00814918撤回不适用

Topical 5-ALA-PDT With Blu-U Therapy Vs. Topical 5-ALA With Pulse Dye Laser In Treatine Recalcitrant Acne Vulgaris

University of Chicago1 个研究点 分布在 1 个国家开始时间: 2009年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Acne complete /incomplete therapy and reoccurence

研究概览

简要总结

The goal of this study is to compare how efficient two different types of PDTs are when used in combination with topical 5-ALA. The two types of PDT lights are Blu-U light and Candela V-beam Pulse Dye Laser.

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 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-79 years of age
  • Patients who failed the topical and oral antibiotics after 6 month therapy.
  • Patients who failed the topical retinoids after 6 month therapy.
  • Patients that are not good candidate to start oral isotretinoin (Accutane) due to contraindications.

排除标准

  • Patients who have had Isotretinoin therapy less that 1 year prior to this ALA-PDT procedure.
  • Patients who have an adverse reaction to light exposure (for example photo- exacerbated seizures).
  • Patients with a history of porphyria.

研究组 & 干预措施

1

Experimental

5-ALA Application and exposure using Blu-U light to 1/2 of face.

干预措施: 5-ALA with Blu-U Light (Drug)

2

Experimental

5-ALA Application and exposure using Candela V-beam Pulse Dye Laser to 1/2 of face.

干预措施: 5-ALA with Candela V-beam Pulse Dye Laser (Drug)

结局指标

主要结局

Acne complete /incomplete therapy and reoccurence

时间窗: 18 months

次要结局

  • Early skin responses 2 weeks post therapy (erythema, scaling, post inflammatory skin changes, fine wrinkling of skin, mottled pigmentation)(2-18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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