The Preventive Role of Fractionated Laser Resurfacing Against Actinic Neoplasia in an At-Risk Geriatric Population
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change from baseline in the number of actinic keratosis due to FLR treatment.
研究概览
简要总结
The purpose of this study is to determine if the Fractionated Laser Resurfacing (FLR) procedure can protect one forearm/wrist from precancerous actinic keratosis (AKs) as well as prevent skin cancer in older subjects with active AKs. This study builds on a similar study ongoing at the Dayton Veterans Administration dermatology clinic. This study is also testing if a photograph of the skin can be used to predict where the AKs and an skin cancers will form.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult Males and Females aged 60 and older
- •Have at least 5 AKs on each forearm/wrist, but no more than 10 to allow for easy monitoring
- •Skin type fair (Fitzpatrick I-II)
- •Females must be post-menopausal and not be on systemic hormone replacement therapy
- •Able to comprehend procedures and risks
排除标准
- •More than 10 AKs on an extremity
- •AKs that are large (2-3+, hyperkeratotic grade 3 lesions)
- •AKs that are very thick (>3 mm)
- •Medical history of diabetes
- •History of poor wound healing or scarring
- •Large tattoos that can interfere with study
- •Other serious health issues and other skin diseases that could interfere with the study
- •Recent (within 1 year) field therapies such as efudex cream or PDT to forearms/wrists.
- •Planning to leave region in next 5 years
- •Subjects with allergies to xylocaine will be excluded if they need this topical anesthetic.
研究组 & 干预措施
Fractionated Laser Resurfacing - Left Arm
Left forearm treatment of fractionated laser resurfacing.
干预措施: Fractionated Laser Resurfacing (Device)
Fractionated Laser Resurfacing - Right Arm
Right forearm treatment of fractionated laser resurfacing.
干预措施: Fractionated Laser Resurfacing (Device)
结局指标
主要结局
Change from baseline in the number of actinic keratosis due to FLR treatment.
时间窗: Up to 5 years
Investigator will assess the number of actinic keratosis on both forearms at each visit.
Change from baseline in the number of non-melanoma skin cancers due to FLR treatment.
时间窗: Up to 5 years
Investigator will assess the number of actinic keratosis on both forearms at each visit.
次要结局
- Skin dysplasia change, in regards to non-melanoma skin cancer, from baseline due to FLR treatment.(Up to 5 years)
- Skin dysplasia change, in regards to actinic keratosis, from baseline due to FLR treatment.(Up to 5 years)