NCT01677221已完成不适用
A Clinical Trial Investigating the Effects of Acleara Needle Insert on Acne Vulgaris
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Subject assessment of reduction in acne lesion size
研究概览
简要总结
This prospective, open-label study will be conducted in 15 healthy subjects per clinical site ages 14 or older who meet the inclusion/exclusion criteria. Each subject may have up to 5 lesions treated on the face, chest or back with the Acleara insert. Subjects will receive up to 3 follow up visits and evaluated for improvement in acne lesions and monitored for any adverse events.
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
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects >14 years of age
- •Subject has mild to moderate acne vulgaris on the face, chest or back.
- •Subject has one or more inflammatory acne lesions on face, chest or back.
- •Willingness to participate in the study
- •Informed consent agreement signed by the subject
- •Willingness to follow the treatment schedule and post treatment care requirements
- •Willingness to remain on current acne therapy as directed by the Investigator.
排除标准
- •Subject has an infection or other dermatologic condition (aside from acne) in the area to be treated
- •Subject is immunosuppressed
- •Subject is unable to comply with treatment or follow-up visits
- •Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
结局指标
主要结局
Subject assessment of reduction in acne lesion size
时间窗: 24-72 hours, 1-2 weeks, 1 month
Percentage range of lesion reduction
次要结局
未报告次要终点
研究者
研究点 (4)
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