Effectiveness of Fractionated Laser Resurfacing to Protect Geriatric Skin From Actinic Neoplasia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 1
- 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
This study is following up on previous studies that have demonstrated that geriatric subjects respond different to ultraviolet B (UVB) light than young subjects. The treatment of geriatric skin with dermal rejuvenation therapies (dermabrasion, fractionated laser resurfacing) restores the appropriate UVB response. Ongoing studies have tested the ability of fractionated laser resurfacing (FLR) to assess how long this wounding effect lasts-and have found that this appears to be a durable response which lasts for at least two years. The findings that FLR protects geriatric skin at two years is the impetus for this study.
This study is an interventional study to assess if FLR treatment of one forearm of geriatric subjects with multiple actinic keratosis will result in the short-term removal of actinic keratosis, and the long-term decrease in levels of future actinic keratosis and other non-melanoma skin cancers in comparison to the untreated arm.
Study length and visit: The first part of the study is completed in 1 day then there are follow up visits at 90 days and every 6 months for 5 years.
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
- •Diagnosed with Actinic Keratosis within the past 6 months
- •At least 60 years of age, or older
- •Ability to comprehend procedures and risks versus benefits
- •Able to provide Informed Consent
- •Fair Skin (Fitzpatrick Type I or II)
- •Possess both Right and Left Forearms
排除标准
- •Uncontrolled Diabetes Mellitus
- •Not able to comprehend procedures or risks versus benefits
- •Pregnant or nursing
- •Large tattoos on forearms
- •History of abnormal healing or scarring (i.e., keloids)
- •Any disease that gets worse while in the sun
- •Use of topical or oral anti-inflammatory medication or steroids
- •Allergy to lidocaine
- •Current use of photosensitizing medication
研究组 & 干预措施
Factionated Laser Resurfacing - Right Arm
Right forearm treatment of fractionated laser resurfacing.
干预措施: Fractionated Laser Resurfacing (Device)
Factionated Laser Resurfacing - Left Arm
Left 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.
Change From Baseline in the Number 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.
次要结局
未报告次要终点