NCT03818555Unknown不适用
A Prospective, Multicenter, Postmarket Study of Sebacia Microparticles Treatment in Patients Using Topical Acne Products for Mild to Moderate Inflammatory Acne Vulgaris
Sebacia, Inc.12 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2019年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 125
- 试验地点
- 12
- 主要终点
- Inflammatory Lesion Count
研究概览
简要总结
Postmarket study of Sebacia Microparticles treatment during adoption into clinical use for patients with mild to moderate 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
- Other
- 盲法
- None
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 facial inflammatory acne vulgaris (IGA 2 or 3)
- •Between 10 and 50 papules/pustules
- •Fitzpatrick skin phototype I, II or III
- •Able to provide informed consent and comply with study schedule and other requirements
排除标准
- •Moderately severe or severe acne vulgaris (IGA 4 or 5)
- •Nodulocystic acne, significant scarring or excoriation
- •Requires oral retinoid, antibiotic or corticosteroid for acne
- •New or fluctuating hormone or hormone-regulating therapy
- •Photosensitivity or allergy to gold
- •Medical or mental health condition that would pose a risk to patient or impair treatment and evaluation
结局指标
主要结局
Inflammatory Lesion Count
时间窗: Months 2, 3, 6, 9 and 12
Percent change in number of inflammatory lesions from baseline
次要结局
- Investigator's Global Assessment(Months 2, 3, 6, 9 and 12)
- Physician's Overall Assessment of Improvement(Months 2, 3, 6, 9 and 12)
研究者
研究点 (12)
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