NCT05050149已完成2 期
A Multicenter, Phase 2, Open-Label Study Evaluating The Safety And Efficacy of Sirolimus 3.9% Topical Gel (PTX-022) In The Treatment of Microcystic Lymphatic Malformations
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 7
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
This study evaluates the safety and efficacy of PTX-022 (sirolimus) Topical Gel 3.9% w/w in the treatment of Microcystic Lymphatic Malformations. The participant will receive 3 months of PTX-022 treatment by the end of the study.
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
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be 6 years or older
- •Diagnosed with Microcystic Lymphatic Malformations
- •Able and willing to comply with all protocol-required activities
- •Willing and able to provide written informed consent
排除标准
- •Any significant concurrent condition that could adversely affect participation.
- •Any history of allergy or hypersensitivity to sirolimus, or sirolimus-like medications or to PTX-022
- •Patient's deemed by the investigator as unwilling or unable to remain compliant with all tests and procedures, including adherence to study drug administration and other protocol-required activities.
研究组 & 干预措施
Experimental: PTX-022
Experimental
PTX-022 QTORIN
干预措施: PTX-022 (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: 4 months
次要结局
未报告次要终点
研究者
研究点 (7)
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