Open, Prospective, Single-center Study Evaluating the Efficacy and Safety of 0.05% Ingenol Mebutate (Picato® 500) in the Treatment of Basal Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy, in terms of complete remission, of 2 cycles (for patients who did not respond to the first cycle) of a topical treatment with picato 0.05% gel topical
研究概览
简要总结
Basal cell carcinomas (BCCs) are the most common form of cancer. The treatment of BCC can be surgical or topical for the low-risk subtypes. Topical treatments used for BCC are imiquimod and photodynamic therapy (PDT). Ingenol mebutate could provide a fast and easy topical therapy for BCC. Data regarding the treatment of BCC with ingenol mebutate are still limited. The investigators propose a pilot study to investigate the efficacy of 1 or 2 courses of ingenol mebutate 0,05%, on superficial and nodular BCC
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Histologically confi rmed, primary, previously untreated, nodular or superfi cial basal-cell carcinoma not arising on the face or scalp, measuring 1 to 4 cm (large axis)
排除标准
- •Basal cell carcinomas of the scalp
- •Basal cell carcinomas recurrent, sclerodermiform, infiltrant, metatypic
- •Allergic patient to treatment products
- •Patient treated with immunosuppressants, immunomodulators, systemic cytotoxic agents or local corticosteroids applied in the CBC area during the 4 weeks prior to the screening visit
研究组 & 干预措施
TREATMENT
干预措施: Picato 0.05% Topical Gel (Drug)
结局指标
主要结局
To evaluate the efficacy, in terms of complete remission, of 2 cycles (for patients who did not respond to the first cycle) of a topical treatment with picato 0.05% gel topical
时间窗: 6 months
To evaluate the efficacy, in terms of complete remission, of 1 of a topical treatment with picato 0.05% gel topical
时间窗: 3 months
次要结局
- Evaluate the tumor response according ultrasound(3 months)
- Evaluate the tumor response according to dermoscopic(6 months)
- Evaluate the tumor response according to ultrasound(6 months)
- determine the tolerance of the treatment: complete remission after 2 cycle(3 months and 6 months)
- Evaluate the tumor response according Optical Coherence Tomography(3 months)
- Evaluate the tumor response according to Optical Coherence Tomography(6 months)
- determine the tolerance of the treatment: complete remission after 1 cycle(3 months)
- Evaluate the tumor response according dermoscopic,(3 months)
- Evaluate the tumor response according histology(6 months)
- Evaluate the tumor response according to clinical criteria(6 months)