Open Label, Phase 3 Study of the Efficacy of Combination of Imiquimod and Cryosurgery in the Treatment of Primary Basal Cell Carcinomas of the Skin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Efficacy of immunocryosurgery in the treatment of basal cell carcinoma of the skin
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of cryosurgery during continuing imiquimod application in the treatment of basal cell carcinoma of the skin.
详细描述
Evaluation of efficacy:
- Number of patient: N=50
- Inclusion criteria: Basal cell carcinoma of the skin proven with biopsy
- Exclusion criteria: (1) Size of the tumors >2cm; (2) Distance from the eyelid <1cm; (3)Number of tumors >5
Treatment protocol: 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 10-15 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. Persisting erosion will be considered as persistence of the tumor and imiquimod will be continued for another 3 weeks with/or without a cryosurgery session. The patients will be evaluated at 1,3,6,12 months after discontinuation of imiquimod and yearly thereafter for relapse. In case of clinical relapse, it will be confirmed by biopsy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Basal cell carcinoma of the skin
- •Size < or = 2cm
- •Number of tumors < or = 5
- •Distance from eyelids, mouth >1cm
排除标准
- •Size >2cm Number of tumors > 5 Distance from eyelids or mouth < or = 1cm
结局指标
主要结局
Efficacy of immunocryosurgery in the treatment of basal cell carcinoma of the skin
时间窗: 1 months
Basal cell carcinomas of the skin will be treated with immunocryosurgery and the efficacy will be measured 1, 3, 6, and 12 months. Reappearance of the tumor within the primary lesion and 1cm around it will be considered as relapse.
次要结局
- Feasibility and Tolerability of Immunocryosurgery(1 month)
研究者
Ioannis Bassukas
Associate Professor of Dermatology
University of Ioannina