NCT00314756已完成4 期
Topical Imiquimod 5% Cream in the Treatment of Nodular Basal Cell Carcinoma After Initial Treatment With Curettage
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- histologic clearance of basal cell carcinoma
研究概览
简要总结
To assess the efficacy of treating a nodular basal cell carcinoma with imiquimod cream after initial treatment with curettage
详细描述
The primary objective of this study is to evaluate the efficacy of imiquimod 5% cream on nodular BCC lesions treated 5x/week for 6 weeks after primary treatment with curettage without electrodesiccation. The secondary objective of this study is to evaluate the cosmetic outcome after treatment of the lesions using this modality.
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
- 是
入选标准
- •Are willing and able to give informed consent;
- •Are at least 18 years of age;
- •Are willing to comply with all study requirements, evaluations, and procedures
- •Have 1 clinically typical, visible nodular BCC lesion which meets the following criteria:
- •a primary lesion (not recurrent, not previously treated or biopsied)
- •non-infected
- •size between 0.25 and 1.5 cm2
- •located at least 1 cm from the eyes, nose, mouth, ear, and hairline to exclude the H-zone of the face
- •clinically consistent with nodular BCC
- •histologically consistent with nodular BCC and have no histological evidence of a morpheaform or micronodular pattern
- •suitable for treatment with surgical excision
- •easily identifiable and treatable by subject or reliable subject representative
- •Are free of any significant physical abnormalities or previous scarring in the potential application site area that may cause difficulty with examinations.
- •Are willing to stop using over-the-counter retinol products or products containing alpha or beta hydroxyacids in the treatment and surrounding area 8 hours prior to treatment with the imiquimod cream and clinic visits.
排除标准
- •Have evidence of clinically significant, unstable, cardiovascular or immunosuppressive, hematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, or gastrointestinal abnormalities or disease that may interfere with completion of the study.
- •Have any dermatological disease in the treatment or surrounding area that may be exacerbated by treatment with imiquimod or cause difficulty with examination.
- •Have a BCC lesion located within 1 cm of the eyes, nose, mouth, ear, and hairline.
- •Are pregnant at the screening or treatment initiation visit.
- •Have known allergies to any excipient in the study cream
- •Have undergone any surgical procedures in the potential treatment area within 4 weeks of the screening/treatment initiation visit. In addition, skin in the potential application area must be healed.
结局指标
主要结局
histologic clearance of basal cell carcinoma
次要结局
未报告次要终点
研究者
研究点 (2)
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