The Use of Microneedles to Expedite Treatment Time in Photodynamic Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Difference in the Percentage of Complete Clearance of the Actinic Keratoses
研究概览
简要总结
The aim of this study is to investigate how varying incubation periods of topical aminolevulinic acid after pretreatment with microneedle application can facilitate the penetration and efficacy of photodynamic therapy.
详细描述
The current standard of care of photodynamic therapy to treat actinic keratoses includes pre-treatment of the area with topical aminolevulinic acid for 1 hour, followed by treatment with blue light. In a previous study, the investigators showed pretreatment of microneedles enhance penetration of topical aminolevulinic acid as compared to the control group.
The aim of this study is to investigate how varying incubation periods of topical aminolevulinic acid after pretreatment with microneedle application can facilitate the penetration and efficacy of 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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age and older
- •Subjects has actinic keratoses and qualifies for photodynamic therapy
- •Do not meet any of the exclusion criteria
排除标准
- •Subjects who smoke
- •Subjects who have a photosensitizing condition such as lupus, porphyria, or similar condition
- •Subjects who have established allergy to topical ALA
- •Subjects who have had a documented nonmelanoma skin cancer on the face over the past 6 months
研究组 & 干预措施
10-minute Incubation with Microneedle Roller & Sham
10-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.
干预措施: Microneedle Roller (Device)
10-minute Incubation with Microneedle Roller & Sham
10-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.
干预措施: Aminolevulinic Acid (Drug)
10-minute Incubation with Microneedle Roller & Sham
10-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.
干预措施: Blue Light (Radiation)
20-minute Incubation with Microneedle Roller & Sham
20-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.
干预措施: Microneedle Roller (Device)
20-minute Incubation with Microneedle Roller & Sham
20-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.
干预措施: Aminolevulinic Acid (Drug)
20-minute Incubation with Microneedle Roller & Sham
20-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.
干预措施: Blue Light (Radiation)
结局指标
主要结局
Difference in the Percentage of Complete Clearance of the Actinic Keratoses
时间窗: Baseline, 2 Months
The primary endpoint will be the difference in the percentage of complete clearance of the actinic keratoses as an intraindividual comparison between the treatment groups.
次要结局
- Visual Analog Pain Scale(Immediately Post-Treatment)