A Multi-Center, Prospective, Randomized, Double-Blind, Within-Subject Controlled, Phase 2a Study to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Scar Revision Surgery on Transverse Hypertrophic Scars on the Lower Abdomen Resulting From Previous Surgeries in Healthy Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 主要终点
- Reduction in recurrence of hypertrophic scarring 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 abdominal scar.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 in general good health
- •Previous partial hysterectomy, Cesarean section or abdominoplasty surgery resulting in a transverse hypertrophic scar of ≥ 11 cm in length
- •Scar to be revised must have been present for > 9 months
排除标准
- •Use of tobacco or nicotine-containing products
- •Pregnant or lactating
- •Post-menopausal or full hysterectomy
研究组 & 干预措施
RXI-109
Treatment with RXI-109 on one side of revised scar and a placebo comparator on the other side. Treatment to begin either immediately or 2 weeks following the scar revision surgery.
干预措施: RXI-109 (Drug)
Placebo
Treatment with RXI-109 on one side of revised scar and a placebo comparator on the other side. Treatment to begin either immediately or 2 weeks following the scar revision surgery.
干预措施: Placebo (Drug)
结局指标
主要结局
Reduction in recurrence of hypertrophic scarring 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 revision of a hypertrophic abdominal scar
次要结局
- Safety of RXI-109(9 months)