NCT05838833招募中2 期
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of INV-001 Administration for the Prevention of Scar After Thyroidectomy
Innovo Therapeutics, Inc.1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2023年2月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Observer overall opinion of POSAS
研究概览
简要总结
The goal of this study is to evaluate the efficacy and Safety of INV-001 administration for the prevention of scar after thyroidectomy.
Participants will be asked to apply ointment on their scar for 12 weeks.
详细描述
to evaluate the efficacy
-investigator check POSAS and VSS
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who got thyroidectomy due to Thyroid cancer
- •has scar longer than 3 cm
排除标准
- •have history about Keloid or Hypertrophic scar
- •have infection on surgical site
研究组 & 干预措施
Low dose
Experimental
low dose ointment
干预措施: INV-001 (Drug)
High dose
Experimental
high dose ointment
干预措施: INV-001 (Drug)
Placebo
Placebo Comparator
same ingredient with active drug except API
干预措施: INV-001 (Drug)
结局指标
主要结局
Observer overall opinion of POSAS
时间窗: 12 weeks
POSAS POSAS: Patient Observer Scar Assessment Scale
次要结局
- Observer overall opinion of POSAS(3, 6 weeks)
研究者
研究点 (1)
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