Double-Blind, Vehicle-Controlled Study to Evaluate Cellular and Molecular Events During Four Weeks of Treatment for Actinic Keratosis With Aldara (Imiquimod) Cream, 5%
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Gene expression profiling of treated lesions
研究概览
简要总结
Treatment of actinic keratosis with imiquimod cream is expected to cause changes in the genes that are turned on, and turned off, by skin cells. Some of the drug induced changes in skin cells should also be visible using a special microscope. This study examines both types of changes.
详细描述
The primary objective of this study was to assess apoptosis by examining the gene expression profiles of actinic keratosis (AK) lesions that were treated with imiquimod 5% cream or vehicle cream once daily 3 times per week for 4 weeks. Secondary objectives were to assess the utility of confocal microscopy (CM) to visually track cellular response to treatment with study cream compared with clinical and histological evaluations, and to evaluate the safety of treatment with imiquimod in subjects with AK on the balding scalp.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Have actinic keratoses on balding scalp
- •Discontinuation of tanning bed use
- •Discontinuation of moisturizers
- •Avoidance of retinol products
排除标准
- •Uncontrolled, clinically significant medical condition
- •Dermatologic disease other than actinic keratosis in treatment area
研究组 & 干预措施
Imiquimod cream
Imiquimod 5% cream containing 12.5 mg of imiquimod per 250 mg of cream Applied 3 times per week for 4 weeks
干预措施: Aldara (imiquimod 5% cream) (Drug)
Vehicle cream
Vehicle cream 250 mg Applied 3 times per week for 4 weeks
干预措施: Vehicle cream (Drug)
结局指标
主要结局
Gene expression profiling of treated lesions
时间窗: weeks 1, 2, and 4, and at 4 weeks post-treatment
次要结局
- Confocal microscopic evaluation before, during and post treatment(weeks 1, 2, 4 and at 4 weeks post-treatment)