NCT02758041已完成不适用
A Study to Evaluate Sebacia Microparticles in Patients With Inflammatory Acne Vulgaris
Sebacia, Inc.6 个研究点 分布在 2 个国家目标入组 85 人开始时间: 2016年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 6
- 主要终点
- Percent reduction in lesion count from baseline
研究概览
简要总结
This study is proposed to evaluate Sebacia Microparticle treatment in patients with facial inflammatory acne vulgaris.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 16-45 years of age.
- •Moderate to moderately-severe facial inflammatory acne vulgaris
- •Fitzpatrick skin phototype I-III
排除标准
- •Pregnant, lactating, nursing or planning to become pregnant
- •Tattoo in the treatment area
- •Active skin disease, excessive scarring or excess facial hair in the treatment area
- •Certain current or recent acne treatments
- •Recent light treatments including Intense Pulsed Light or other lasers, microdermabrasion or chemical peels in the treatment area
- •Contraindicated for laser treatment, or is unable or unwilling to avoid excessive sun exposure or tanning bed use
- •Known allergy to gold
结局指标
主要结局
Percent reduction in lesion count from baseline
时间窗: Baseline, Week 12, Week 24, Week 36
次要结局
- Improvement in Investigator Global Acne Score(Baseline, Week 12, Week 24, Week 36)
研究者
研究点 (6)
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