Aminolevulinic Acid-photodynamic Therapy for Facial Actinic Keratosis Treatment and Prevention: A Long-term (3 Years) Follow-up of Prospective, Randomized, Multicenter-clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Number of new Actinic Keratoses
研究概览
简要总结
Background Actinic keratoses (AKs) are often treated separately, lesion by lesion. However, in the past years, AKs have been described as a field disease and not limited to single clinically apparent lesions. Treatment should therefore target an area of field change which may treat the subclinical AKs and reduce the risk of development of further AKs, second tumours, and local recurrence.
Objectives The investigators sought to investigate whether field ALA-PDT of facial actinic keratosis would prevent new AKs, in comparison with a lesion area receiving the same ALA-PDT, in patients with clinical signs of field cancerization.
Methods Eighty patients, previously diagnosed as having AKs of the face, were randomized distribution into two groups. 10% aminolaevulinic acid (ALA)-PDT for field treatment was on one group and for a lesion area (Vehicle control cream was applied to the non-lesion area) was on the other group. During the next 5-year period of follow up, patients were clinically evaluated for new AKs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Single (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
- 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.
研究组 & 干预措施
ALA for all face group
Scales and crusts were gently removed by curettage, and the lesions to be treated were scraped carefully to avoid bleeding. Immediately afterwards, a 1-mm thick layer of 10% ALA was applied to the all face. The area was covered with an occlusive dressing for 3 h, after which the remaining cream was removed with saline gauze, and the red fluorescence of porphyrins was visualized with Wood's lamp. Treatment area (all face)was then separately illuminated with red light-emitting diode lamps with peak emission at 630 nm and total light dose of 100 J/cm2. The treatment is once a week for total 3 times. The patients then follow up in clinic 3 years after their treatment to have the number of actinic keratoses counted.
干预措施: ALA (Drug)
ALA for AK lesion group
Scales and crusts were gently removed by curettage, and the lesions to be treated were scraped carefully to avoid bleeding. Then a 1-mm thick layer of 10% ALA was applied to the lesion and 5 mm of surrounding healthy tissue. Vehicle control cream was applied to the non-lesion area. All area was covered with an occlusive dressing for 3 h, after which the remaining cream was removed with saline gauze, and the red fluorescence of porphyrins was visualized with Wood's lamp. Treatment area (all face)was then separately illuminated with red light-emitting diode lamps with peak emission at 630 nm and total light dose of 100 J/cm2. The treatment is once a week for total 3 times. The patients then follow up in clinic 3 years after their treatment to have the number of actinic keratoses counted.
干预措施: ALA (Drug)
结局指标
主要结局
Number of new Actinic Keratoses
时间窗: 1, 3, 6, 9, 12, 18, 24, 30, 36 months after treatment
The change in number of actinic keratoses at each follow-up will be measured as the primary outcome
次要结局
- The clearance rate of Actinic Keratoses(1 month after treatment)
研究者
Xiuli Wang
Clinical Professor
Shanghai Dermatology Hospital