PDT Versus the Combination of Jessner's Solution and 35% TCA for Treatment of Actinic Keratoses on Upper Extremities: A Randomized Controlled Split-arm Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Percentage of total AKs cleared
研究概览
简要总结
The purpose of this study is to to compare photodynamic therapy (PDT) versus the combination of Jessner's solution and 35% trichloroacetic acid (TCA) chemical peels for the treatment of actinic keratoses on upper extremities.
This is a randomized clinical trial. Approximately 60 participants with actinic keratoses on both upper arms will be randomized to have one arm receive photodynamic therapy, while the contralateral arm receives Jessner's solution followed immediately by 35% TCA. AKs will be counted before treatment and 2-8 weeks after treatment. This study is a pilot study designed to determine the feasibility of this procedure.
Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •>18 years of age
- •Interested in receiving treatment for actinic keratoses on the bilateral upper arms
- •In good general health as assessed by the investigator
- •Participants must have the ability to understand and the willingness to sign a written informed consent prior to registration on study
排除标准
- •Patient pregnant or nursing
- •Patient with extensive concurrent skin conditions (such as eczema, psoriasis, etc) on upper extremities that would interfere with treatment as determined by the treating physician
- •Subject unwilling to sign an IRB approved consent form
- •Participants who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function are not eligible
研究组 & 干预措施
Chemical Peels
One upper arm will be exposed to Jessner's Solution AND 35% Trichloroacetic acid peel
干预措施: Chemical Peels (Drug)
Photodynamic Therapy
One upper arm will be exposed to blue light therapy
干预措施: Photodynamic Therapy (Procedure)
结局指标
主要结局
Percentage of total AKs cleared
时间窗: 2-8 weeks after treatments
Percentage of total AKs cleared will be calculated by counting the number of AKs before treatment and 2-8 weeks after treatments.
次要结局
未报告次要终点
研究者
Murad Alam
Professor of Dermatology
Northwestern University