Short Contact Protocols to Reduce Pain During Treatment of Actinic Keratoses With 10% ALA Gel Red-light Photodynamic Therapy (PDT)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Treatment Efficacy Based on Participant AK Lesion Clearance
研究概览
简要总结
The goal of this clinical trial is to see if shorter Photodynamic Therapy (PDT) treatment times will still be effective at treating actinic keratoses (AK) while reducing or eliminating the pain that patients sometimes experience during conventional PDT treatment. The main questions it aims to answer are:
- Will the application of the nanoemulsion (10% ALA gel), in the absence of occlusion, still achieve significant inflammation and lesion clearance?
- Will shortened incubation times of Ameluz still achieve significant inflammation and lesion clearance?
- Will the new test regimens achieve reduced pain during illumination?
- Will the new test regimens be safe?
Participants will be randomly assigned to one of three treatment regimens, which will determine the length of time that the topical medication will incubate on the face before red light exposure in PDT treatments. The incubation period will be either 10 minutes, 20 minutes, or 60 minutes.
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
- •Minimum of 10 actinic keratoses lesions on the face.
- •Female subjects must not become pregnant during the study
- •Subjects must be able to understand and willing to sign a written informed consent document.
排除标准
- •Pregnant or nursing.
- •Using any topical treatment on their AKs; must stop at least one month prior.
- •Currently undergoing treatment for other cancers with medical or radiation therapy.
- •Patients with a known hypersensitivity to 5-aminolevulinic acid or any component of the study material.
- •Patients with history of a photosensitivity disease, such as porphyria cutanea tarda.
研究组 & 干预措施
Regimen B
Apply topical aminolevulinic acid gel and incubate for 20 minutes prior to red light source
干预措施: Topical aminolevulinate (10% ALA gel) (Drug)
Regimen B
Apply topical aminolevulinic acid gel and incubate for 20 minutes prior to red light source
干预措施: Red light illumination (Device)
Regimen C
Apply topical aminolevulinic acid gel and incubate for 60 minutes prior to red light source
干预措施: Topical aminolevulinate (10% ALA gel) (Drug)
Regimen A
Apply topical aminolevulinic acid gel and incubate for 10 minutes prior to red light source
干预措施: Topical aminolevulinate (10% ALA gel) (Drug)
Regimen A
Apply topical aminolevulinic acid gel and incubate for 10 minutes prior to red light source
干预措施: Red light illumination (Device)
Regimen C
Apply topical aminolevulinic acid gel and incubate for 60 minutes prior to red light source
干预措施: Red light illumination (Device)
结局指标
主要结局
Treatment Efficacy Based on Participant AK Lesion Clearance
时间窗: Lesion clearance at Visit 3 (month 2) and at Visit 4 (month 6)
To test the hypothesis that a short-contact PDT protocol with Ameluz and red light will produce lesion clearance outcomes that are statistically non-inferior to the traditional, painful protocol. This will be measured by Clinical Efficacy, which will be based on the AK lesion counts and lesion clearance rate after two treatments.
Differences in Pain Level Reported Throughout Exposure to Red Light
时间窗: Pain measured during illumination with red light (during a 10 min period) at Visit 1 (Day 3) and at Visit 3 (Month 2)
Pain will be reported by the participants during illumination will be measured on a subjective 11-point visual-analog scale (VAS scale 0= no pain, 10 = intolerable pain)
次要结局
- Patient Satisfaction Survey as Measured by Treatment Outcome Score(6 months)
- Patient Satisfaction Survey as Measured by Cosmetic Outcome Score(At month 6)
- Number of Participant Reported Adverse Events and Side Effects(Up to 6 days (Day 6) after Visit 1)