Indoor Daylight Photo Dynamic Therapy (PDT) for Actinic Keratosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Change in the amount of PpIX in the lesion
研究概览
简要总结
The purpose of this study is to understand better if indoor daylight Photo Dynamic Therapy (PDT) can provide effective lesion clearing versus conventional red lamp light therapy.
详细描述
Subjects who enroll into this research study, their participation in this study will last up to 6 months. They will be asked to return to the clinic 3-4 times.
Subjects will be randomized into one of two study arms:
Arm 1 - Indoor Daylight PDT Therapy Arm 2 - FDA Approved Standard Light Therapy Treatment
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
- 否
入选标准
- •All patients with actinic keratosis appearing at the Dermatology Clinic for PDT treatment.
- •Age ≥ 18 years older.
排除标准
- •Pregnant women or women who are breast-feeding.
- •Any patients with a condition that makes them not suitable for clinical PDT.
结局指标
主要结局
Change in the amount of PpIX in the lesion
时间窗: Baseline and immediately post procedure
Secondary diagnostic study to determine if low-cost cellphone-based skin dosimetry in PDT can facilitate objective measurement of drug levels.
Changes or clearing of the lesions
时间窗: Baseline, immediately post-procedure (2 hours) and one and 6 months
The primary aim of this study is to study if indoor daylight PDT can be as effective as regular lamp light PDT. This study can be confounded by the amount of PpIX produced in the lesions as well as the clearing of lesions at one month and six months.
次要结局
未报告次要终点
研究者
Michael S. Chapman
Staff Physican
Dartmouth-Hitchcock Medical Center