NCT02217228已完成不适用
A Randomized, Prospective, Multicenter, Controlled Study With Blinded Assessment to Determine the Safety and Effectiveness of the Sebacia Acne Treatment System in the Treatment of Inflammatory Acne Vulgaris
Sebacia, Inc.19 个研究点 分布在 1 个国家目标入组 394 人开始时间: 2014年9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
- 394
- 试验地点
- 19
- 主要终点
- Number of of adverse events
研究概览
简要总结
Prospective, randomized multicenter study to examine the safety and effectiveness of Sebacia microparticles with or without laser in the treatment of moderate to moderately-severe 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
- 15 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, 15 - 45 years of age
- •Able to provide informed consent/assent; minors will provide assent while parent or legal guardian will provide consent
- •Moderate to moderately severe (3 or 4) inflammatory acne vulgaris by Investigator's Global Assessment
- •Subject has 25 to 75 inflammatory lesions on the cheeks, chin and forehead, not concentrated in one area
- •Subject has Fitzpatrick skin phototype I, II or III
- •Subject is in good health, willing to participate and able to comply with protocol requirements
排除标准
- •Severe acne (Investigator's Global Assessment 5) with significant scarring potential and greater than 2 nodular lesions
- •Clinically relevant history of keloids
- •Facial tattoos
- •Acne conglobata, acne fulminans, chloracne, drug-induced acne
- •Active concomitant skin disease, excessive scarring or excess facial hair
- •Heavily tanned skin; unable or unwilling to avoid tanning beds/excessive sun exposure
- •Acne medication and therapy restrictions - time period prior to Baseline (below)
- •Oral retinoids - 6 months
- •Other systemic medications - 4 weeks
- •Topical retinoids, steroids, antibiotics - 2 weeks
- •OTC topical treatments - 1 week
- •Light treatments (including IPL or laser), microdermabrasion and/or peels - 8 weeks
- •Investigational drug, biologic or device - 30 days
- •Gold therapy of any type for any reason - EXCLUDED
- •Pregnant, lactating, nursing or planning to become pregnant during the study period
- •Known allergy to gold, ethanol, diisopropyl adipate, Polysorbate 80
- •Clinically relevant condition that makes participation unsafe or that would interfere with study treatment and assessment
研究组 & 干预措施
Sebacia microparticles and laser
Experimental
Gold microparticle suspension + laser treatment x 3 over the course of two weeks
干预措施: Sebacia microparticles and laser (Device)
Vehicle suspension and laser
Experimental
Vehicle suspension + laser treatment x 3 over the course of two weeks
干预措施: Vehicle suspension and laser (Device)
Sebacia microparticles without laser
Experimental
Gold microparticle suspension treatment x 3 over the course of two weeks
干预措施: Sebacia microparticles without laser (Device)
结局指标
主要结局
Number of of adverse events
时间窗: Screening to 12 Weeks
Mean percent change in inflammatory lesion count from Baseline to Week 12
时间窗: Week 12
次要结局
- Mean absolute change in inflammatory lesion count from Baseline to Week 12(Week 12)
- Success by Investigator's Global Assessment at Week 12 (defined as 2-point decrease from Baseline IGA)(Week 12)
研究者
研究点 (19)
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