NCT00814528撤回不适用
Photodynamic Therapy Mediated by Topical Application of 5- ALA for the Treatment of Actinic Keratoses
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
- Actinic keratosis /incomplete therapy and reoccurence
研究概览
简要总结
The purpose of this study is to compare the treatment of skin growths called actinic keratoses (AK) with 5-ALA PDT, an FDA-approved treatment, versus treatment with other conventionally used FDA-approved agents such as cryotherapy, Imiquimod, or 5-fluorouracil (5-FU).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-95 years old
- •Diagnosied with actinic keratoses.
排除标准
- •Patients who have had Isotretinoin therapy less that 1 year prior to screening.
- •Patients who have an adverse reaction to light exposure (for example photo- exacerbated seizures).
- •History of porphyria
研究组 & 干预措施
1
Experimental
Application of 5-ALA PDT to some lesions on skin with "Blue U" light source (417 nm).
干预措施: 5-ALA plus Blu-Light (Drug)
2
Experimental
5-FU, Imiquimod or treatment with cryotherapy to lesions on the skin.
干预措施: 5-FU, Imiquimod or treatment with cryotherapy (Drug)
结局指标
主要结局
Actinic keratosis /incomplete therapy and reoccurence
时间窗: 18 months
次要结局
- Erythema(2 weeks post therapy)
研究者
研究点 (1)
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