A Pilot Study of the Treatment of Facial Nodular and Nodulocystic Basal Cell Carcinoma With Double Curettage and Cautery Followed by Application of Imiquimod to the Base
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Basal Cell Carcinoma recurrence rates in 3 years
研究概览
简要总结
The purpose of this study is to determine recurrence rates of nodular Basal Cell Carcinomas on the face removed with curettage and electrodessication (cautery) followed by application of Imiquimod cream to the base and further to achieve lower recurrence rates than after treatment with curettage and electrodessication alone.
详细描述
Basal Cell Carcinomas (BCC) are the commonest form of skin cancer in the white population. The face is where they most frequently occur and the nodular BCCs are the commonest type. Curettage and cautery/electrodessication (C&C) has been an established way of management of nodular BCCs for years, being a simple surgical procedure readily performed in outpatient clinics with good aesthetic results and high cure rates. The purpose of this study is to determine recurrence rates of nodular BCCs on the face removed with C&C followed by application of Imiquimod cream to the base and further to achieve lower recurrence rates than after treatment with C&C alone. Imiquimod is an immune response modifier with anti-tumour effects already licensed for the treatment of superficial BCCs in the UK.
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
- 49 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Well-defined primary, not previously treated nodulo-cystic BCC
- •Size of the lesions: ≤ 1cm diameter
- •Facial lesions
- •Patient compliance competent
- •Patient physically able to apply the treatment (cream)
排除标准
- •Recurrent lesions
- •Superficial, morphoeic or pigmented BCC
- •Lesions close to vital structures; i.e. where C&C is not considered a standard treatment (eyelids, inner canthus, free borders)
- •Lesions within 1 cm of the eyelids, nose, lips and hairline
- •Immunosuppressed patients
- •Women in childbearing age, pregnancy and breast-feeding
- •Ages <50 or >90
- •Patients compliance incompetent
- •Patients physically incapable to apply the treatment (cream)
- •Patients with Gorlin Syndrome (nevoid Basal Cell Carcinoma syndrome)
结局指标
主要结局
Basal Cell Carcinoma recurrence rates in 3 years
次要结局
未报告次要终点