NCT06239480招募中3 期
SELVA: A Multicenter, Phase 3 Baseline-Controlled Study Evaluating the Safety and Efficacy of QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Microcystic Lymphatic Malformations
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 15
- 主要终点
- Overall microcystic lymphatic malformations Investigator Global Assessment (mLM-IGA)
研究概览
简要总结
SELVA: A Multicenter, Phase 3 Baseline-Controlled Study Evaluating the Safety and Efficacy of QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Microcystic Lymphatic Malformations
The main purpose of this study is to assess the change in microcystic lymphatic malformations IGA after 24 weeks of treatment with QTORIN 3.9% Rapamycin Anhydrous Gel in approximately 40 participants with microcystic lymphatic malformations. Efficacy will be evaluated at 24 weeks and patients have the option of continuing on treatment for >24 weeks.
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
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be at least 3 years of age at time of consent/assent
- •Participant must have a clinically confirmed superficial/cutaneous microcystic lymphatic malformation
排除标准
- •Participants who have vascular malformations that interfere with evaluating the target microcystic lymphatic malformation
- •Participants with complicated vascular anomalies with severe systemic symptoms that require systemic therapy
- •The participant's treatment area is mainly in any wet mucosa or within the orbital rim
- •Participants who are pregnant or planning to become pregnant
研究组 & 干预措施
Active
Experimental
干预措施: QTORIN 3.9% Rapamycin Anhydrous Gel (Drug)
结局指标
主要结局
Overall microcystic lymphatic malformations Investigator Global Assessment (mLM-IGA)
时间窗: At Week 24
A multi-point scale with higher values indicating improvement.
次要结局
- Overall patient global impression of change (PGI-C)(Change from Baseline to Week 24)
- Change in Overall Patient Global Impression of Severity (PGI-S)(Change from Baseline to Week 24)
- Incidence and severity of adverse events(From Baseline to Week 24)
- Change in Overall Clinician Global Impression of Severity (CGI-S)(Change from Baseline to Week 24)
- Change in the blinded clinician microcystic lymphatic malformations Multicomponent Severity Scale (mLM-MCSS)(At Week 24)
- Change in the live clinician microcystic lymphatic malformations Multicomponent Severity Scale (mLM-MCSS)(Change from Baseline to Week 24)
研究者
研究点 (15)
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