Imiquimod 5% Cream for the Treatment of Periocular Basal Cell Carcinoma
试验速览
- 阶段
- 4 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- post-treatment biopsy
研究概览
简要总结
This study aimed to prove the efficacy and safety of the use of imiquimod 5% cream in the periorbital region.
详细描述
This is a prospective study including patients presenting in aggregate primary lesions affected by nodular BCC of the eyelid (all subjects were submitted to incisional biopsy at 2 mm punch) at the commencement of this study. All were submitted to a local treatment with Imiquimod 5% cream (Aldara ®), once daily, 5 days per week for 8-16 weeks (average). All subjects were submitted to a new incisional biopsy at 2 mm punch, after 12 weeks of treatment, and all of them were monitored monthly up to now.If positive biopsy (residue tumor) cases will managed with surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients whose injuries were confirmed by anatomical and pathological study (periocular superficial basal cell carcinoma).
- •Patients with clinical counter indication for reconstructive surgery (high surgical risk).
- •Patients who have refused a restorative surgery. (aesthetic reasons)
- •Patients who have signed the free and informed consent.
排除标准
- •Patients who have a hypersensitivity reaction to the formula components.
- •Children under 12 years of age.
- •Pregnant and breastfeeding women.
- •Patients whose injury was not confirmed by anatomical and pathological study.
- •Individuals with previous autoimmune or inflammatory disease.
- •Patients who have refused to sign the free and informed term of consent.
研究组 & 干预措施
nodular BCC of the eyelid
Patients with nodular BCC of the eyelid
干预措施: Imiquimod 5% cream (Drug)
结局指标
主要结局
post-treatment biopsy
时间窗: post-treatment biopsy
次要结局
未报告次要终点
研究者
Erick Marcet Santiago de Macedo
Imiquimod 5% Cream for the Treatment of Periocular Basal Cell Carcinoma
University of Sao Paulo