NCT01815450已完成2 期
BLI1100-202: BLI1100 for the Treatment of Moderate to Severe Acne Vulgaris
Braintree Laboratories15 个研究点 分布在 1 个国家目标入组 369 人开始时间: 2013年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 369
- 试验地点
- 15
- 主要终点
- Change in total lesion count
研究概览
简要总结
The purpose of this study is to compare the safety and efficacy of BLI1100 formulations to placebo for the treatment of moderate to severe 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
- Double (Investigator, 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
- •Males or females 12 to 45 years of age with facial acne vulgaris
- •Qualifying Investigator's Global Assessment severity score
- •Qualifying number of non-inflammatory lesions
- •Qualifying number of inflammatory lesions
排除标准
- •Facial hair (beard), excessive scarring, sunburn or other disfigurement that may obscure the accurate assessment of acne grade
- •Using medications that are reported to exacerbate acne
- •Any clinically relevant finding at their baseline physical examination or dermatological medical history such as severe systemic diseases or diseases of the facial skin
- •Have a known hypersensitivity or previous allergic reaction to any of the components
- •Patients who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days
- •Patients who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures
研究组 & 干预措施
BLI1100
Experimental
BLI1100 topical cream
干预措施: BLI1100 (Drug)
BLI1100 - modified formulation
Experimental
BLI1100 topical cream
干预措施: BLI1100 - modified formulation (Drug)
Placebo
Placebo Comparator
Topical cream
干预措施: Placebo (Drug)
结局指标
主要结局
Change in total lesion count
时间窗: Baseline to Week 12
次要结局
- Percent change in total lesion count(Baseline to Week 12)
- Investigator's Global Assessment(12 weeks)
- Local Tolerability Score(12 weeks)
研究者
研究点 (15)
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