NCT00520910已完成2 期
Single-Blind Study Determining the Efficacy of Polypodium Leucotomos Extract Supplement in Decreasing UVA Premutagenic and Photoaging Markers
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in Common Deletion (CD) Value in DNA of Skin Biopsy Sample
研究概览
简要总结
With this study, the investigators will like to determine if taking a dose of the study medication, called Polypodium leucotomos (PL), prevents some of the changes in the skin caused by the adverse effects of UVA, a type of ultraviolet light.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects,
- •18 years of age or older,
- •with Fitzpatrick skin types II and III.
排除标准
- •Pregnancy
- •Personal history of skin cancer
- •History of abnormal photosensitivity
- •Patients with history or being exposed to other forms of radiation (other than sunlight)
- •History or current exposure to asbestos
- •Patients taking any drug that might alter the response of skin to UVR (including, but are not limited to, doxycycline, sulfas, psoralens, and amiodarone)
- •Patients unable to undergo skin biopsies
- •History of abnormal scarring
- •History of adverse reaction to local anesthesia
研究组 & 干预措施
Polypodium leucotomos extract
Experimental
Subject is given a 7.5 mg/kg dose of Polypodium leucotomos.
干预措施: Polypodium leucotomos (Drug)
结局指标
主要结局
Change in Common Deletion (CD) Value in DNA of Skin Biopsy Sample
时间窗: baseline, 24 hours
CD is determined by semiquantitative real-time polymerase chain reaction.
8-oxo-7,8-dihydro-2'-Deoxyguanosine (8-oxo-dG) Quantification in Skin Biopsy Sample Taken From Final Visit
时间窗: 24 hours
次要结局
未报告次要终点
研究者
Robert S. Kirsner
Professor
University of Miami
研究点 (1)
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