NCT07552077招募中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 Angiokeratomas (LOTU)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of the experimental drug PTX-022 in the treatment of angiokeratomas
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 angiokeratoma
- •Able and willing to comply with all protocol-related 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
- •Patients 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
Open label
Experimental
干预措施: PTX-022 (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: 3 months
Overall Angiokeratoma Investigator Global Assessment (AK-IGA)
时间窗: 3 months
Overall Patient Global Impression of Change (PGI-C)
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (4)
Loading locations...
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