Twelve Month Follow-Up Evaluation of Subjects Participating in DUSA-CP0108 (A Phase 3 Study of Photodynamic Therapy With Levulan Kerastick Topical Solution + Blue Light Versus Topical Solution Vehicle + Blue Light for the Treatment of Actinic Keratoses on the Upper Extremities)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 206
- 试验地点
- 13
- 主要终点
- Duration of Response
研究概览
简要总结
The purpose of this study is to determine the long-term safety and efficacy of Levulan PDT in subjects with multiple actinic keratosis of the upper extremities who received treatment as part of the DUSA CP0108 study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Subject must have been enrolled in the DUSA-CP0108 study, completed their assigned treatment and Visit 6 (Week 12).
排除标准
- 未提供
研究组 & 干预措施
ALA
Subjects who received ALA in CP0108
干预措施: BLU-U Blue Light Photodynamic Therapy Illuminator (Device)
Vehicle
Subjects who received Vehicle in CP0108
干预措施: Topical Solution Vehicle (Drug)
ALA
Subjects who received ALA in CP0108
干预措施: Aminolevulinic Acid (ALA) (Drug)
Vehicle
Subjects who received Vehicle in CP0108
干预措施: BLU-U Blue Light Photodynamic Therapy Illuminator (Device)
结局指标
主要结局
Duration of Response
时间窗: one year
the time from Week 12 (in the DUSA-CP0108 study) to the visit at which a previously treated and cleared lesion recurs. If a subject begins or receives treatment for previously cleared AK lesions in the Treatment Area between scheduled visits, the date the treatment started will be the end of treatment response, or, if the start date is unknown, the visit prior to starting the new treatment will be the end of treatment response.
Lesion Recurrence Rate
时间窗: Month 12
the proportion of lesions that were CR at Week 12 in CP0108 that are visible or palpable at Visit 10, will be determined for all ALA-PDT treated subjects who have at least one AK designated as "clear" at Week 12 in the DUSA-CP0108 study.
Subject Recurrence Rate
时间窗: Month 12
percentage of subjects who had achieved 100% clearance at Visit 6 (Week 12) in CP0108, that have one or more previously treated (as part of CP0108) AK lesion(s) present in the Treatment Area at any visit during CP0108A follow-up
Duration of Lesion Response
时间窗: one year
the time from Week 12 (in the DUSA-CP0108 study) to the visit at which the AK lesion recurs for all ALA-PDT treated subjects who have at least one AK designated as "clear" at Week 12 in the DUSA-CP0108 study. If a previously cleared lesion receives treatment between scheduled visits, the date the treatment started will be the end of treatment response for that lesion, or, if the start date is unknown, the visit prior to starting the new treatment will be the end of treatment response.
次要结局
未报告次要终点