An Open-label Study to Evaluate the Safety and Long-Term Clinical Efficacy of Imiquimod 5% Cream Applied Once Daily 7 Days Per Week for 6 Weeks in the Treatment of Superficial Basal Cell Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 169
- 试验地点
- 18
- 主要终点
- Number of Participants With Sustained Clearance Rate of Superficial Basal Cell Carcinoma (sBCC)
研究概览
简要总结
An open-label study to evaluate the safety and the ability of Imiquimod 5% cream, applied topically, to clear superficial basal cell carcinoma and to keep it clear for 5 years of follow-up.
详细描述
Evaluate the long-term sustained clearance rate, defined as the proportion of those subjects clinically clear of basal cell carcinoma (BCC) at the treated superficial BCC (sBCC) target tumor site at the 12-week posttreatment visit who remain clear during a 5 year follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Have at least 1 previously untreated superficial basal cell carcinoma tumor
- •Minimum tumor size 0.5 cm2 and maximum diameter of 2.0 cm
排除标准
- •Evidence of clinically significant, unstable medical conditions
- •Cannot have recent use of topical steroids or retinoids in the treatment area.
研究组 & 干预措施
Aldara
Aldara (imiquimod) cream 5% applied 7 times per week for 6 weeks
干预措施: Imiquimod 5% cream (Drug)
结局指标
主要结局
Number of Participants With Sustained Clearance Rate of Superficial Basal Cell Carcinoma (sBCC)
时间窗: 5 years
Number of participants clinically clear of superficial basal cell carcinoma at the treated target tumor site at the 12-week posttreatment visit (ie, initial clearance rate) who remain clear during a 5 year follow-up period.
次要结局
- Number of Participants Cleared of Superficial Basal Cell Carcinoma at 12 Weeks(12 week posttreatment visit)