NL-OMON55856已完成3 期
A Multicenter, Randomized, Double blind, Vehicle-controlled, Phase 3 Efficacy and Safety Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Subjects with Basal Cell Nevus Syndrome - PATIDEGIB study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 14
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 99（—）
入选标准
- •1. The subject must be at least 18 years old at the Screening visit.
- •2. The subject must meet diagnostic criteria for BCNS (Inclusion Criteria 3).
- •3. The subject must have had at least 10 (with at least 3 on the face)
- •clinically typical BCCs present within 24 months prior to Randomization
- •(Baseline/Day 1). Additionally, the subject must have at least 2 BCCs with
- •longest diameter <5 mm present on the face prior to randomization.
- •4. The subject must be willing to abstain from application of a non-study
- •topical medication (prescription or over the counter) to facial skin for the
- •duration of the trial.
排除标准
- •1. The subject has used topical treatment to the face or systemic therapies
- •that might interfere with the evaluation of the study IP.
- •2. The subject is known to have a hypersensitivity to any of the ingredients in
- •3. The subject has uncontrolled systemic disease.
- •4. The subject has been treated for invasive cancer within the past 5 years
- •excluding non-melanoma skin cancer, Stage I cervical cancer, ductal carcinoma
- •in situ of the breast, or chronic lymphocytic leukemia (CLL) Stage 0.
研究者
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