NCT02219074已完成不适用
A Feasibility Study to Evaluate the Safety and Preliminary Efficacy of the Sebacia Acne Treatment System for the Treatment of Acne Vulgaris
Sebacia, Inc.4 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2011年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 350
- 试验地点
- 4
- 主要终点
- Number of adverse events
研究概览
简要总结
Prospective, multicenter study with multiple arms to examine the safety and effectiveness of the Sebacia Acne Treatment System for the treatment of acne vulgaris.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of moderate to severe acne vulgaris
排除标准
- •use of oral retinoid therapy in the past 12 months
- •pregnancy, lactating, or planning to become pregnant
- •excessive scarring in the treatment area, or other condition that would impact the ability to evaluate acne
研究组 & 干预措施
Sebacia microparticle and laser treatment
Experimental
干预措施: Sebacia microparticle and laser treatment (Device)
Vehicle and laser treatment
Sham Comparator
干预措施: Vehicle and laser treatment (Device)
结局指标
主要结局
Number of adverse events
时间窗: Screening to 26 weeks
Change in inflammatory lesion count
时间窗: Week 12
次要结局
- Investigator Global Assessment(Week 12)
研究者
研究点 (4)
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