Treatment of Field Cancerization for Reduction in Tumor Burden - A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Count of the Number of Actinic Keratosis and Non Melanoma Skin Cancers in the Treatment Area
研究概览
简要总结
This project aims to treat field cancerization ( pre-skin cancers) in a manner that will reduce the future pre-skin cancers and non-melanoma skin cancers in patients with significant photodamage.
This is 3 year prospective, randomized, controlled comparison of a single treatment with carbon dioxide laser resurfacing vs. carbon dioxide resurfacing plus autologous epidermal skin graft from a non sun exposed site vs. control.
Thirty subjects will receive treatment with each of the modalities.
The primary measures of efficacy are (a) count of the number of actinic keratosis and non melanoma skin cancers, (b) blinded evaluation of severity from standard digital photographs taken before and after the treatments, and (c) change in histology before and after treatment. Safety measures include (a) pain, (b) scarring, (c) wound healing, (d) and infection
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Count of the Number of Actinic Keratosis and Non Melanoma Skin Cancers in the Treatment Area
时间窗: Entire study period (3 years)
This is done at every visit over the 3 year period
次要结局
未报告次要终点
研究者
Richard Rox Anderson, MD
Harvard Medical School Professor in dermatology, Director of the Wellman Center for Photomedicine; and adjunct Professor of Health Sciences and Technology at MIT
Massachusetts General Hospital