A Multi-Center, Prospective, Randomized, Single-Blind, Within-Subject Controlled, Phase 2a Study to Evaluate the Effectiveness and Safety of RXI-109 on the Outcome of Keloid Excision Surgery in Healthy Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 主要终点
- Reduction in the recurrence of a keloid after keloid excision
研究概览
简要总结
To evaluate the effectiveness of RXI-109 in reducing the recurrence of keloid formation following elective keloid excision.
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
- Single (Participant)
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.
- •Two keloids of approximately similar size and anatomical location on the earlobe, neck, or torso.
- •Keloids to be excised must have been present for > 1 year.
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
Cohort 1
Treatment with RXI-109 at the site of one excised keloid and a placebo at the site of a second excised keloid. Dosing to begin at the time of surgery.
干预措施: Placebo (Drug)
Cohort 2
Treatment with RXI-109 at the site of one excised keloid and a placebo at the site of a second excised keloid. Dosing to begin two weeks after surgery.
干预措施: RXI-109 (Drug)
Cohort 1
Treatment with RXI-109 at the site of one excised keloid and a placebo at the site of a second excised keloid. Dosing to begin at the time of surgery.
干预措施: RXI-109 (Drug)
Cohort 2
Treatment with RXI-109 at the site of one excised keloid and a placebo at the site of a second excised keloid. Dosing to begin two weeks after surgery.
干预措施: Placebo (Drug)
结局指标
主要结局
Reduction in the recurrence of a keloid after keloid excision
时间窗: 6 months
To evaluate the effectiveness of RXI-109 in reducing the recurrence of keloid formation following elective keloid excision
次要结局
- Safety of RXI-109(6 months)