An Independent Evaluator-Blind, Dose-Escalation, Untreated-Controlled, Within-Subject, Phase 2a Therapeutic Exploratory Clinical Trial to Evaluate the Efficacy and Safety of BMT 101 Administration for the Prevention of Hypertrophic Scar
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Reducing the hypertrophic scar after scar revision surgery
研究概览
简要总结
An Independent Evaluator-Blind, Dose-Escalation, Untreated-Controlled, Within-Subject, Phase 2a Therapeutic Exploratory Clinical Trial
详细描述
As a comparative evaluation between the control group (untreated-control) and the study group (treatment) within a subject, it was decided to assign ten subjects to each of the three dose groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male and female adults aged 19-55 years
- •Those who plan to undergo a revision surgery to remove hypertrophic scar resulted from a previous abdominal surgery
- •Those who voluntarily signed the written consent and agreed to participate in the study.
排除标准
- •Pregnant or lactating women
- •Those with clinically significant systemic disease (e.g. diabetes, hematologic disease, allergic or immunogenic systemic skin disease)
研究组 & 干预措施
BMT101
BMT101 injection (treatment)
干预措施: BMT101 (Drug)
结局指标
主要结局
Reducing the hypertrophic scar after scar revision surgery
时间窗: Week 2, 6, 10, 22
to evaluate Differences in Visual Analogue Scale (VAS) score between the study group and the control group when independent evaluators assessed the severity of the hypertrophic scars.
Safety evaluation of BMT101
时间窗: Week 2, 6, 10, 22
To assess severity and frequency of reported adverse events and clinically-relevant changes in laboratory testing after elective revision of a hypertrophic scar
次要结局
未报告次要终点