Therapeutic Induction of Dermal Remodeling in Veterans to Prevent Actinic Neoplasia Caused by Chronic Environmental Exposure to Ultraviolet Radiation
The investigators' previous studies demonstrate geriatric subject skin responds differently to ultraviolet B (UVB) light compared to young subject skin, which contribute to increased rates of nonmelanoma skin cancer (NMSC) and actinic keratosis (AK) development in geriatric populations. Previously, the investigators have shown that therapeutic dermal remodeling interventions (e.g., fractionated laser resurfacing and microneedling) can restore appropriate skin responses to UVB in geriatric skin. The investigators also demonstrated fractionated laser resurfacing (FLR) reduced rates of NMSC and AK development (compared to untreated control skin) in at risk geriatric subjects.
This interventional study will assess the ability of two therapeutic dermal remodeling therapies, microneedling and trichloroacetic acid chemical (TCA) peel, to impact NMSC and AK development in at risk geriatric subjects. Geriatric subjects will be enrolled into one of two study groups. In the first group, one arm will be treated with microneedling and the other arm will not be treated on day 1. In the second group, one arm will be treated with TCA peel and the other arm will not be treated on day 1. Subjects will subsequently be monitored for number of NMSC and AK on treated and untreated (control) forearms in each group. In addition to monitoring NMSC and AK development, subjects at the Richard L. Roudebush VAMC will undergo skin punch biopsy at one of their follow up visits for microscopic and molecular analyses of treated and untreated skin.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Matthew J Turner, MD
- 电话号码：(317) 988-5000
- 邮箱：matthew.turner@va.gov
学习地点
-
-
Indiana
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Indianapolis、Indiana、美国、46202-2884
- Richard L. Roudebush VA Medical Center, Indianapolis, IN
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接触：
- Matthew J Turner, MD
- 电话号码：317-988-5000
- 邮箱：matthew.turner@va.gov
-
首席研究员：
- Matthew J Turner, MD
-
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Ohio
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Dayton、Ohio、美国、45428
- Dayton VA Medical Center, Dayton, OH
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接触：
- Jeffrey B Travers, MD
- 邮箱：jeffrey.travers@va.gov
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接触：
- Craig A Rohan, MD
- 邮箱：craig.rohan@va.gov
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Adult Males and Females age 60 and older with 5 or more AKs on each forearm
- Skin type fair-Fitzpatrick I-II
- Able to comprehend procedures and risks
Exclusion Criteria:
- More than 10 AKs on an extremity, or AKs that are large (2-3+)
- Medical history of Diabetes
- Coagulopathy or easy bleeding
- 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
- Planning to leave region in next 4 years
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Microneedling - Male
Forearm treatment with microneedling
|
Microneedling- a mechanical tool that makes tiny holes in a superficial part of the skin
|
|
实验性的：Microneedling - Female
Forearm treatment with microneedling
|
Microneedling- a mechanical tool that makes tiny holes in a superficial part of the skin
|
|
实验性的：Trichloroacetic acid peel - Male
Forearm treatment with trichloroacetic acid peel
|
Trichloroacetic acid peel that removes a superficial part of the skin
|
|
实验性的：Trichloroacetic acid peel - Female
Forearm treatment with trichloroacetic acid peel
|
Trichloroacetic acid peel that removes a superficial part of the skin
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change From Baseline in the Number of Actinic Keratosis due to treatment.
大体时间：up to 4 years
|
Investigator will assess the number of actinic keratosis on both forearms
|
up to 4 years
|
|
Change From Baseline in the Number Non-Melanoma Skin Cancers due to treatment.
大体时间：up to 4 years
|
Investigator will assess the number of nonmelanoma skin cancers on both forearms.
|
up to 4 years
|
合作者和调查者
调查人员
- 首席研究员：Matthew J Turner, MD、Richard L. Roudebush VA Medical Center, Indianapolis, IN
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- ONCE-003-25S
- RD001084 (其他赠款/资助编号：U.S. Veterans Administration)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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