NCT03070691撤回2 期
A Randomized, Double-blind, Vehicle-controlled, Multicenter Trial of Topically Administered LDE225 Cream (0.75% Bid) to Evaluate Clearance of Basal Cell Carcinoma in Adult Patients With Nevoid Basal Cell Carcinoma Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- To demonstrate superiority of topical LDE225 versus vehicle in terms of treatment success in patients with NBCCs. Measure: Complete clinical clearance and complete histological clearance of BCCs
研究概览
简要总结
This 22 week study will assess the efficacy, safety, and tolerability of LDE225 versus vehicle when applied topically to basal cell carcinoma (BCC) in patients with NBCCS. Patients will treat multiple BCCs for up to 12 weeks. Treatment success is defined as complete clinical clearance and complete histological clearance in BCCs.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Adult greater than 18 years old, male or female.
- •Patient must be able to understand and communicate with the investigator and comply with the requirements of the study.
- •Typical presentation of NBCCS in the opinion of the investigator
- •At least one of the major clinical criteria of NBCCS.
- •Multiple BCCs during the screening period
排除标准
- •Any concomitant dermatological disease that could confound the evaluations, based on the discretion of the investigator.
- •Prior exposure to LDE
- •Use of systemic treatment for BCC in the 4 weeks prior to Baseline.
- •Use of topical treatment or photodynamic therapy (PDT) in the 12 weeks prior to Baseline.
- •Use of other investigational drugs at Baseline, or within 30 days or 5 half-lives prior to Baseline, whichever is longer.
- •Clinically significant medical condition, as per judgment of the investigator.
- •History of hypersensitivity to any of the ingredient of the study drug.
- •Pregnant or nursing (lactating) women
- •Women of child-bearing potential and fertile males, UNLESS they are using two birth control methods
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
LDE225 0.75% cream
Active Comparator
干预措施: LDE225B (Drug)
Vehicle
Placebo Comparator
干预措施: Vehicle (Drug)
结局指标
主要结局
To demonstrate superiority of topical LDE225 versus vehicle in terms of treatment success in patients with NBCCs. Measure: Complete clinical clearance and complete histological clearance of BCCs
时间窗: 4 weeks after LDE225 treatment
次要结局
- To assess the safety of topical treatment with LDE225, compared to vehicle. Measure: Reported systemic adverse events in patients with NBCCS(Treatment phase and up to 4 weeks after LDE225 treatment)
- To evaluate the local tolerability of topical treatment with LDE225, compared to vehicle. Measure:Reported local adverse events in patients with NBCCS(Treatment phase and up to 4 weeks after LDE225 treatment)
- To assess the rate of complete clinical clearance of BCCs in patients with NBCCS. Measure: No clinical residual signs of carcinoma(4 weeks after LDE225 treatment)
- To assess the rate of complete histological clearance of BCCs in patients with NBCCS. Measure: No residual tumor tissue(4 weeks after LDE225 treatment)
研究者
研究点 (2)
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