Cyclic PDT for the Prevention of Actinic Keratosis and Non Melanoma Skin Cancer in Solid Organ Transplant Recipients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Time to occurrence of AKs in recently transplanted solid organ recipient
研究概览
简要总结
This is a pilot, phase 2, prospective, comparative study to evaluate the safety and efficacy of the combination of Levulan® Kerastick® for Topical Solution and blue light illumination using the BLU-U® Blue Light Photodynamic Therapy Illuminator (LevulanPDT).
The study hypothesis is that post solid organ transplantation patients, highly susceptible to non-melanoma skin cancer, can be treated safely and effectively through clinical cyclic application of PDT, lessening morbidity and possible mortality for this immunosuppressed patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Received solid organ transplant
- •3-24 months post-transplant (any number of transplant)
- •Time interval of at least 6 days duration where complications such as rejection episodes, viral infections, surgical interventions and therapies with mono or polyclonal antibodies are ruled out by the transplant team.
- •No prior history of NMSC in the treatment fields
- •No AK/Bowen's disease in the treatment fields within the last 3 months.
- •Moderate to severe sun damage
- •Be willing to forego other interventions in the treatment fields than the ones approved by the investigator that would interfere with the protocol or evaluation of the study medication
排除标准
- •Patients with Fitzpatrick's scale skin type IV-VI
- •Cutaneous photosensitivity to wavelengths of 400-450 nm, porphyria or known allergies to porphyrins
- •Known sensitivity to any of the components of the Levulan® Kerastick® for Topical Solution
- •Prior use of topical or systemic therapies that might interfere with the evaluation of the study medication during the study, within a 3 month washout period from the time of the screening visit
- •Unable to return for follow-up visits and tests
- •Any condition or situation which in the Investigator's opinion may put the subject at significant risk, could confound the study results, or could interfere significantly with the subject's participation in the study
研究组 & 干预措施
Levulan® Kerastick® and blue light illumination
Levulan® Kerastick® for Topical Solution will be applied to a designated area for 3 hours without occlusion prior to illumination with blue light using the standard FDA approved treatment time for the BLU-U device of 16 minutes 40 seconds.
Each subject will be randomized to undergo treatment to one side face and one dorsal forearm/hand treatment, while the other side will serve as untreated control. Treatments will be conducted at the beginning of study Day 1 (Initial Treatment), Day 30 after the initial treatment (+ 3 days), Day 180 after initial treatment (+ 30 days), 1 year after the initial treatment (+ 30 days), and every 6 months (+ 30 days) thereafter for 2 additional years.
干预措施: Levulan® Kerastick® (Drug)
Levulan® Kerastick® and blue light illumination
Levulan® Kerastick® for Topical Solution will be applied to a designated area for 3 hours without occlusion prior to illumination with blue light using the standard FDA approved treatment time for the BLU-U device of 16 minutes 40 seconds.
Each subject will be randomized to undergo treatment to one side face and one dorsal forearm/hand treatment, while the other side will serve as untreated control. Treatments will be conducted at the beginning of study Day 1 (Initial Treatment), Day 30 after the initial treatment (+ 3 days), Day 180 after initial treatment (+ 30 days), 1 year after the initial treatment (+ 30 days), and every 6 months (+ 30 days) thereafter for 2 additional years.
干预措施: BLU-U Blue Light Photodynamic Therapy (Drug)
结局指标
主要结局
Time to occurrence of AKs in recently transplanted solid organ recipient
时间窗: 3 Years
Time to occurrence of AK will be calculated from the first visit to the development of an AK in the treatment areas and in the control areas.
Primary prevention of NMSC in recently transplanted solid organ recipient
时间窗: 3 Years
Number of NMSC will be counted for each site using the photographs of the treatment and the control areas. NMSC, including basal cell carcinoma, Bowen's disease and squamous cell carcinoma, will be diagnosis and confirmed histologically by biopsy.
Primary prevention of AKs in recently transplanted solid organ recipient
时间窗: 3 Years
Number of AK will be counted for each site using the photographs of the treatment and the control areas. AKs will be graded by thickness.
Time to occurrence of NMSC in recently transplanted solid organ recipient
时间窗: 3 Years
Time to occurrence of NMSC will be calculated from the first visit to the development of an NMSC in the treatment areas and in the control areas.
次要结局
- Pain control with Levulan-PDT in Solid Organ Transplant Recipient(Day 1, Day 30, Day 180, 12 months, 18 months, 24 months, 30 months, 36 months)
- The number of participants with treatment related adverse events as assessed by the CTCAE v4.0(3 Years)