Measuring Adherence To Topical 5-Fluorouracil in a Clinic Population
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Adherence to Carac® in Subjects With Moderate to Severe Actinic Keratosis.
研究概览
简要总结
The purpose of this research study is to measure adherence to the study drug (Carac) for the treatment of actinic keratoses.
详细描述
The purpose of this research study is to measure adherence to the study drug for the treatment of actinic keratoses. The study drug is 5-Fluorouracil (Carac®); it will be used in this study to treat actinic keratoses on the face and anterior scalp. This proposed study will evaluate adherence to topical Carac® in 20 adults age 50 or greater with actinic keratoses from a clinic population. Adherence data will be collected by the MEMS cap (Medication Event Monitoring System
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
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any male or female 50 years of age or older with moderate to severe actinic keratoses of the face and anterior scalp diagnosed by a dermatologist will be eligible for participation.
排除标准
- •Age less than
- •Known allergy or sensitivity to topical Carac® in the subject.
- •Inability to complete all study-related visits.
- •Introduction of any other prescription medication, topical or systemic, for actinic keratosis while participating in the study.
- •Subjects should not receive surgical or cryotherapy while participating in the study.
- •Pregnant women, women who are breast feeding, or women of child bearing potential who are not practicing two acceptable methods of birth control
研究组 & 干预措施
Fluorouracil 0.5%
each subject will receive the study medication: Carac® 0.5% Fluorouracil, a standard treatment for actinic keratoses. Carac® will be dispensed to the subjects in the original tube with MEMS electronic monitoring caps attached. Subjects will be asked to apply the medication daily to AK lesions
干预措施: Fluorouracil 0.5% (Drug)
结局指标
主要结局
Adherence to Carac® in Subjects With Moderate to Severe Actinic Keratosis.
时间窗: 12 weeks
Measure of adherence by MEMS caps and the % of total prescribed doses that were actually used
次要结局
未报告次要终点