NCT00189280已完成3 期
Open Study to Evaluate the Efficacy and Tolerance of Imiquimod 5% Cream for the Treatment of a Large and/or Multiple Superficial Basal Cell Carcinoma.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Clinical clearance of sBCC
研究概览
简要总结
BCC is the most common form of skin cancer. Current treatment is often surgery but this can be limited by the number of lesions, their location the age of the patient or the potential cosmetic outcome. The purpose of this study is to evaluate the effectiveness of imiquimod, on a non surgical treatment, in subjects with multiple of large sBCCs.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •One or more sBCC on torso, neck or face
- •Total surface area <= 40 sq cm
排除标准
- •Pregnancy or women who are breastfeeding
- •Xeroderma pigmentosum, albinism, epidermodysplasia verruciformis, any genetic anomaly accompanied by skin tumors
- •Metatypical, adnexal, or sclerodermiform carcinomas
- •Current or other previous malignant skin tumor (epidermoid carcinoma, melanoma) in the region of the current lesion
- •Known HIV positive serology
- •Skin tumor that is already or highly likely to become metastatic
- •Presence of a clinically significant anomaly or illness (immunological, cardiovascular, pulmonary, hematological, neurological, hepatic, renal, endocrine, gastrointestinal, collagenous)
- •Previous organ transplant history
研究组 & 干预措施
imiqimod 5% cream
Experimental
干预措施: Imiquimod (Drug)
结局指标
主要结局
Clinical clearance of sBCC
时间窗: 12 or 16 weeks after treatment
次要结局
- Rate of clearance, Cosmetic outcome(12 or 16 weeks after treatment)
- Reduction in size of tumour(12 or 16 weeks after treatment)
- Sustained clearance rate over 3 year follow-up(3 years after treatment)
- Tolerability & QoL(12 or 16 weeks after treatment)
研究者
研究点 (1)
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