Open Label, Randomized Comparison of Two Schemes of Cryosurgery and Imiquimod Combination Treatment for Basal Cell Carcinoma of the Skin
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Comparison of the efficacy of immunocryosurgery and cryoimmunotherapy
研究概览
简要总结
To compare the effectiveness of two application schemes of cryosurgery during a 5 week course of topical imiquimod i.e. cryosurgery at the end of the second week of imiquimod followed by 3 more weeks of imiquimod (immunocryosurgery) versus cryosurgery at day 0 followed by 5 weeks of topical imiquimod (cryoimmunotherapy)
详细描述
Comparison of efficacy
- Number of patients: N=40
- Arms: Two equal arms (20 patients each)
- Inclusion criteria: Basal cell carcinoma of the skin proven with biopsy
- Exclusion criteria: (1) Size of the tumors >5cm; (2) Distance from the eyelid <0,5cm; (3)Number of tumors >5
- Interim analysis: When at least 10 patients are included in each arm or at the end of the first year of the study
The patients will be randomized in 2 groups Group 1 (Immunocryosurgery) and Group 2 (Cryoimmunotherapy)
Treatment protocols:
Group 1 (Immunocryosurgery): Patients will apply imiquimod daily for 14 days on the tumor and a rim of 2mm around the tumor. On day 14 a session of mild cryosurgery (2 cycles of 15 seconds, with open spray liquid nitrogen) will be applied and the patients will continue application of imiquimod for another 3 weeks before being evaluated again.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy proven basal cell carcinoma of the skin
- •Size <5cm
- •Number of tumors <5 cm
- •Distance from eyelids, mouth 0,5cm
排除标准
- •Size >5cm
- •Number of tumors > or =5
- •Distance from eyelids or mouth < or =0.5cm
研究组 & 干预措施
Immunocryosurgery
2 weeks imiquimod, cryosurgery (open spray liquid nitrogen, 2 cycles, 15 secs each), 3 weeks imiquimod
干预措施: Immunocryosurgery (Procedure)
Cryoimmunotherapy
Cryosurgery (open spray liquid nitrogen, 2 cycles, 15 secs each), 5 weeks imiquimod
干预措施: Cryoimmunotherapy (Procedure)
结局指标
主要结局
Comparison of the efficacy of immunocryosurgery and cryoimmunotherapy
时间窗: 1 month
次要结局
未报告次要终点
研究者
Ioannis Bassukas
Associate Professor of Dermatology
University of Ioannina