NCT06653842进行中（未招募）2 期
A Phase 2, Baseline-Controlled Study Evaluating the Safety and Efficacy of PTX-022 (Sirolimus) Topical Gel 3.9% in the Treatment of Cutaneous Venous Malformations
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 15
- 试验地点
- 19
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
A Phase 2, Baseline-Controlled Study Evaluating the Safety and Efficacy of PTX022 (sirolimus) Topical Gel 3.9% in the Treatment of Cutaneous Venous Malformations
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
- •The participant must have a clinically confirmed superficial/ cutaneous (visible on the skin) venous malformation (cVM), referred to as the treatment area. The treatment area may contain a minority (<30%) lymphatic component (mixed venous / lymphatic malformation).
排除标准
- •The participant's treatment area is mainly in any wet mucosa or within the orbital rim. For clarification, no part of the venous malformation should be evaluated or treated if it in mucosa. External genital presentation is permitted.
- •The participant has a known pervasive extension of the lesion into mucosa, bone or tissue (as determined by diagnostic or the investigator) that would impair the ability of the investigator to evaluate the cutaneous components of the lesion.
研究组 & 干预措施
Single-arm, open-label
Experimental
干预措施: QTORIN 3.9% rapamycin anhydrous gel (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: Week 12
次要结局
- Change in Investigator Global Assessment (cVM-IGA) From Baseline to Week 12(Change from baseline to Week 12)
- Overall Patient Global Impression of Change (PGI-C) From Baseline to Week 12(Change from baseline to Week 12)
研究者
研究点 (19)
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