A Follow-up Study to Evaluate Actinic Keratosis Recurrence Rates One Year After Completion of the 1487-IMIQ Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 主要终点
- Efficacy
研究概览
简要总结
The purpose of the study is to obtain recurrence rates and long-term safety data for patients who had been treating actinic keratoses on the face and scalp with 5 % Imiquimod Cream in a previous study.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
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
- •100% clearance of Actinic Keratosis (AK) lesions in the 1487 IMIQ study
排除标准
- •used any treatments in the previous treatment area within 24 hours prior to the follow-up visit
研究组 & 干预措施
Imiquimod 5% cream
No investigational treatments were given during this study.
干预措施: Imiquimod (Drug)
结局指标
主要结局
Efficacy
时间窗: one year after completion of study 1487-Imiq
Efficacy was evaluated by counting AK lesions in the previous treatment area. Subjects at the 1-year follow-up visit with recurrence of lesion(s).
Safety
时间窗: one year after completion of study 1487-Imiq
Safety was evaluated by assessing the area of previous treatment for LSRs and skin quality
Adverse Events
时间窗: one year after completion of study 1487-Imiq
AEs considered by investigator to be possibly or probably related to the 1487-Imiq study medication were documented and recorded.
次要结局
未报告次要终点