NCT01812837已完成不适用
The Use of Microneedles in Photodynamic Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Actinic Keratoses Reduction Percent
研究概览
简要总结
The global aim of this study is to investigate how microneedles can facilitate the penetration and efficacy of photodynamic therapy in the treatment of actinic keratoses
The specific aims are as follows:
- Investigate whether pretreatment with microneedles enhances penetration of topical aminolevulinic acid (ALA) that is marketed as Levulan® Kerasticks by DUSA pharmaceuticals Inc.
- Investigate whether pretreatment with microneedles can decrease the required incubation times of the topical ALA prior to exposure to blue light photodynamic therapy.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who are 18 and older
- •Subjects who have at least 3 actinic keratoses on each side of the forehead
- •Subjects who signed an IRB approved informed consent
排除标准
- •Subjects who smoke
- •Subjects who have a photosensitizing condition such as lupus, porphyria, or similar condition.
- •Subjects who received a diagnosis of skin cancer on the face in past year
- •Subjects who received field treatment for actinic keratoses to the face in the past 60 days
研究组 & 干预措施
20 minutes incubation - with pretreatment
Experimental
干预措施: Microneedle (Device)
20 minutes incubation - with pretreatment
Experimental
干预措施: Aminolevulinic Acid (Drug)
20 minutes incubation - with pretreatment
Experimental
干预措施: Blue light (Radiation)
40 minutes incubation - with pretreatment
Experimental
干预措施: Microneedle (Device)
40 minutes incubation - with pretreatment
Experimental
干预措施: Aminolevulinic Acid (Drug)
40 minutes incubation - with pretreatment
Experimental
干预措施: Blue light (Radiation)
60 minutes incubation - with pretreatment
Experimental
干预措施: Microneedle (Device)
60 minutes incubation - with pretreatment
Experimental
干预措施: Aminolevulinic Acid (Drug)
60 minutes incubation - with pretreatment
Experimental
干预措施: Blue light (Radiation)
60 minutes incubation - no pretreatment
Sham Comparator
干预措施: Aminolevulinic Acid (Drug)
60 minutes incubation - no pretreatment
Sham Comparator
干预措施: Blue light (Radiation)
结局指标
主要结局
Actinic Keratoses Reduction Percent
时间窗: one month after treatment
次要结局
未报告次要终点
研究者
研究点 (1)
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