NCT01481155Unknown不适用
Prospective, Single-center, Investigator-blinded, Randomized, Half-side, Comparative Study of Photodynamic Therapy vs. CO2 Laser Therapy in Treatment of Actinic Keratoses
Ruhr University of Bochum2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2011年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Number of actinic keratoses 3 months after treatment
研究概览
简要总结
The purpose of this study is to determine whether photodynamic therapy or CO2 laser therapy is superior in the treatment of actinic keratoses with respect to efficacy and side effects.
详细描述
Ablative laser therapy and photodynamic therapy are widely used and accepted therapeutic methods to treat multiple actinic keratoses, yet comparative studies are rare. The purpose of this study is to compare both treatments intraindividually with respect to treatment efficacy and side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- •men and women with clinical and histological diagnosed, symmetrical distributed actinic keratoses
- •at least 2 actinic keratoses, on each of both treatment areas at least one
- •Patients must be 18 years or older.
排除标准
- •Age 17 years or younger
- •lack of patient's informed consent for any of the two treatments
- •contraindication for Co2 therapy or for photodynamic therapy
- •skin infection in the treatment area
结局指标
主要结局
Number of actinic keratoses 3 months after treatment
时间窗: 3 months
次要结局
- Histologic features(1 month after therapy)
- Epidermal thickness in optical coherence tomography(1 month after therapy)
研究者
Dr. Nina Scola
Dr. med. Nina Scola, consultant in Ruhr University of Bochum
Ruhr University of Bochum
研究点 (2)
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