NCT01640912已完成1 期
A Phase 1 Single Center, Randomized, Double-Blind, Ascending Dose, Within-Subject Controlled Study of RXI-109 for the Treatment of Incision Scars Made in the Pannus of Healthy Women Who Will Later Undergo Elective Abdominoplasty
RXi Pharmaceuticals, Corp.0 个研究点目标入组 15 人开始时间: 2012年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 主要终点
- To assess the safety and tolerability of intradermal administration of RXI-109
研究概览
简要总结
The primary purpose of this study is to evaluate the safety and tolerability of a single intradermal administration of RXI-109 at small surgical incisions in the abdominal skin that will later be removed during an elective abdominoplasty. The effect of RXI-109 versus placebo on scarring at these incision sites will be evaluated visually and histologically.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subject must be a female in general good health with normal screening values
- •Subject must be a good surgical candidate for an elective abdominoplasty
- •Subjects must not be pregnant or lactating and utilize an effective method of contraception (if child-bearing potential exists)
排除标准
- •Currently pregnant or lactating
- •BMI greater than 35 at screening
- •Use of tobacco or nicotine-containing products within the month prior to enrollment and while on study
- •Any medical condition or current therapy which would make the subject unsuitable for this study in the opinion of the PI
研究组 & 干预措施
RXI-109
Experimental
干预措施: RXI-109 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
To assess the safety and tolerability of intradermal administration of RXI-109
时间窗: 12 weeks
Evaluate safety and tolerability of RXI-109 at site of intradermal injection. Examination and assessment of any and all local and systemic toxicities
次要结局
- To assess the effect of RXI-109 on scar formation following small surgical incisions(12 weeks)
研究者
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