NCT03303170已完成不适用
A Prospective, Multicenter, Randomized, Controlled, Evaluator-Blinded Study of the Safety and Effectiveness of Sebacia Microparticles as an Accessory to 1064 nm Nd:Yag Laser in the Treatment of Facial Inflammatory Acne Vulgaris
Sebacia, Inc.22 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2017年9月25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
- 168
- 试验地点
- 22
- 主要终点
- Change in number of inflammatory acne lesions
研究概览
简要总结
Prospective, randomized, controlled, parallel group clinical study with blinded assessment evaluating Sebacia Microparticles (SM) with Nd:Yag laser in facial inflammatory 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
- 12 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild to moderate acne vulgaris
- •At least 15 inflammatory acne lesions
- •Skin phototype I - III
- •Able to understand and comply with study requirements
排除标准
- •Severe acne vulgaris
- •Nodulocystic acne
- •Ongoing use of medications and/or treatments for acne
- •New hormone regimen (used for less than 12 weeks)
- •Significant medical or mental health condition
研究组 & 干预措施
Nd:Yag Laser
Active Comparator
干预措施: Nd:Yag Laser (Device)
Sebacia Microparticles
Experimental
干预措施: Sebacia Microparticles (Device)
结局指标
主要结局
Change in number of inflammatory acne lesions
时间窗: Week 12
次要结局
未报告次要终点
研究者
研究点 (22)
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