CTIS2023-507528-21-00招募中1 期
A Multicenter, Randomized, Double blind, Vehicle-controlled, Phase 3 Efficacy and Safety Study of Patidegib Gel 2% for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Subjects with Gorlin Syndrome - SGT-610-01
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 156
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •The subject must be at least 18 years old at the Screening Visit, The subject must be confirmed to have a PTCH1 mutation, The subject must have at least 10 BCCs on the face at Randomization (Baseline/Day 1), The subject must be willing to abstain from application of any non-study topical medication (prescription or over the counter) to their facial skin for the duration of the trial, except as prescribed by the investigator
排除标准
- •The subject has used topical treatment to the face or systemic therapies that might interfere with the evaluation of the study Investigational Product (IP), The subject is known to have hypersensitivity to any of the ingredients in the IP formulation, The subject has uncontrolled systemic disease, The subject has been treated for invasive cancer within the past 5 years excluding chronic lymphocytic leukemia Stage 0 and non-melanoma skin cancer, Stage I cervical cancer, or ductal carcinoma in situ of the breast, Previous Hedgehog inhibitor therapy was considered to have failed for reasons other than unfavorable side effect(s)
研究者
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