Cure Rates of Superficial Basal Cell Carcinoma Following 1 Versus 3 Cycles of Electrodessication & Curettage: A Randomized Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Difference in Cure Rates of Superficial BCC Following One Cycle of ED&C Versus Three Cycles of ED&C.
研究概览
简要总结
This is a prospective, randomized clinical trial conducted at the Unviersity of Wisconsin (UW) Dermatology Clinic located at 1 S. Park Street, Madison, WI 53715. There are no controls. Subjects meeting eligibility criteria are randomly divided into one of two treatment groups (ED&C x 1 cycle or ED&C x 3 cycles) using computer generated random numbers. One cycle of ED&C is defined according to standard technique currently employed. It involves scraping away the tumor with a curette (ring- shaped instrument) and then burning the curetted site with a small electric needle (electrodessication). During Visit 1, the surgical site is marked, local numbing medication is injected, and 1 or 3 cycles of ED&C is/are performed by board-certified dermatologists or a dermatology resident under the direct supervision of a board certified dermatologist. All follow-up visits (3, 6, 9, and 12 months after Visit 1) include skin evaluations by the physician who performed the ED&C. The lesion site is examined, measured, and photographed for clinical evidence of recurrence, as defined by a new lesion within the previously treated site. If there is evidence of possible tumor recurrence at the treated surgical site during Visit 2, 3, 4 or 5, then the lesion will be biopsied using a shave procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Untreated, biopsy proven superficial type basal cell carcinoma (BCC-S) on the trunk and/or extremities
- •Age greater than 21
- •Women with childbearing potential (including those who are pregnant/lactating)
- •Able to provide written informed consent
排除标准
- •Aggressive histology on initial biopsy (i.e. morpheaform, infiltrative, desmoplastic, or purely micronodular)
- •Prior history of BCC or other skin cancer at the same location
- •Lesion > 2 cm
- •Patients with basal cell nevus syndrome
- •Transplant patients
- •Immunocompromised patients
- •Recurrent BCC
- •Greater than 2 BCC-S on the trunk and/or extremities
- •Prisoners
- •Allergy to lidocaine or epinephrine
结局指标
主要结局
Difference in Cure Rates of Superficial BCC Following One Cycle of ED&C Versus Three Cycles of ED&C.
时间窗: base line, every 3 months until 12 month completion
Clinical evidence of BCC recurrence post treatment
次要结局
未报告次要终点
