Conventional Photodynamic Therapy vs. Painless Photodynamic Therapy for Actinic Keratosis#a Randomized, Open-label Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The clearance rate of Actinic Keratoses
研究概览
简要总结
This study is being done to compare a new, continuous illumination and short Incubation time regimen of aminolevulinic acid photodynamic therapy#ALA-PDT) to a conventional regimen for treatment of Actinic Keratosis. The hypothesis is that the continuous illumination approach will be less or even no painful, but equally efficacious, as the old regimen.
详细描述
This study is being done to compare a new, continuous illumination and short Incubation time regimen of aminolevulinic acid photodynamic therapy#painless-PDT) to a conventional regimen for treatment of Actinic Keratosis. The hypothesis is that the continuous illumination approach will be less or even no painful, but equally efficacious, as the old regimen.
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 (Outcomes Assessor)
盲法说明
Evaluator assesses photographs without prior knowledge of intervention
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
- •Clinical diagnosed with AK (OLSEN classification grade I, II, III), aged > 18 years (Because no dosing or adverse event data are currently available on the use of topical aminolevulinic acid in patients <18 years of age, children are excluded from this study);
- •All patients are unfit and reluctant to undergo surgery for any reasons, and volunteered to participate in the study and ability to understand and the willingness to sign a written informed consent. Patents are willing to pay for the treatment, and agreed to take a picture of the skin lesions.
排除标准
- •Those who had ALA-PDT and any other studies that affect this study within 12 weeks ;
- •There are other facial diseases that may affect the efficacy evaluation, such as other photodermatosis;
- •Take phototoxic or photosensitizer within 8 weeks;
- •Clinical and / or pathological prove that the tumor has invaded other organs or tissues;
- •Serious immunocompromised persons;
- •scar constitution;
- •Patients are known to have skin photosensitivity, porphyria, or allergies to ALA, light or lidocaine;
- •Persons are suffering from severe internal diseases, mental and mental illness, infectious diseases or pregnant or lactating women.
结局指标
主要结局
The clearance rate of Actinic Keratoses
时间窗: six weeks after treatment
The change rate in lesion clearance of Actinic Keratoses at six weeks after treatment will be measured as the primary outcome
次要结局
- Pain assessment(Immediately, 1st minute, 3rd minute, 5th minute, 10th minute, 30th minute, 1hour ,2hour, 4hour, 12hour, 24hour,48hour ,72hour)
研究者
Xiuli Wang
Director, Clinical Professor
Shanghai Dermatology Hospital