NCT02246465Unknown2 期
An Open-Label, Multi-Center, Prospective, Within-Subject Controlled, Phase 2a Study to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Scar Revision Surgery for Hypertrophic Scars in Healthy Adults
RXi Pharmaceuticals, Corp.0 个研究点目标入组 40 人开始时间: 2014年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 主要终点
- Reducing the recurrence of hypertrophic scar after scar revision surgery
研究概览
简要总结
The purpose of this study is to determine the effectiveness of RXI-109 in reducing the recurrence of hypertrophic scar formation following elective revision of a pre-existing hypertrophic scar.
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
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults, 21-55 years of age
- •General good health
- •Previous surgery or injury resulting in a hypertrophic scar
排除标准
- •Scars on the face or front of neck may not be included in the trial
- •Use of tobacco or nicotine-containing products
- •Pregnant or lactating
研究组 & 干预措施
RXI-109
Experimental
RXI-109 dosed at the site of the revised hypertrophic scar
干预措施: RXI-109 (Drug)
结局指标
主要结局
Reducing the recurrence of hypertrophic scar after scar revision surgery
时间窗: 9 months
To evaluate the effectiveness of RXI-109 in reducing the recurrence of hypertrophic scar formation following elective scar revision surgery by review of photographic results and Patient and Observer Scar Assessment Scales.
次要结局
- Safety evaluation of RXI-109(9 months)
研究者
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