NCT02385760已完成2 期
A Multi-centre, Double-blind, Randomized, Parallel Group, Placebo Controlled Efficacy and Safety Study of Oral CTX-4430 for the Treatment of Moderate to Severe Facial Acne Vulgaris
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 10
- 主要终点
- Efficacy as measured by inflammatory lesion counts
研究概览
简要总结
A multi-centre, double-blind, randomized, parallel group, placebo controlled efficacy and safety study of oral CTX-4430 for the treatment of moderate to severe facial 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 16 Years 至 44 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must provide Informed consent.
- •Male or female aged 16 to 44 inclusive.
- •Moderate to severe facial acne vulgaris as defined in the protocol.
排除标准
- •Positive testing for HIV, HBsAg, or hepatitis C virus (HCV).
- •Females who are pregnant, lactating, or planning to become pregnant during the study.
- •Any systemic medical condition which, in the opinion of the investigator, would put the participant at risk by participation in the study.
- •Any systemic or dermatologic disorder that, in the opinion of the investigator will interfere with the assessment of the study endpoints (e.g. psoriasis).
- •Concurrent or previous use of an investigational drug or device within 30 days prior to screening.
- •The presence of acne conglobata, acne fulminans, secondary acne, or nodulocystic acne.
- •The presence of known or suspicious unresolved dermatological cancerous or pre-cancerous lesions.
- •Hypersensitivity or idiosyncratic reaction to compounds related to CTX-4430 or any of its components.
研究组 & 干预措施
Active
Experimental
CTX-4430 oral capsule, 100 mg, once-daily for 12 weeks
干预措施: CTX-4430 (Drug)
Placebo
Placebo Comparator
Placebo: identical oral capsule, without active ingredient, once-daily for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Efficacy as measured by inflammatory lesion counts
时间窗: 12 weeks
Change from baseline in inflammatory lesion count after 12 weeks of treatment as compared to placebo.
Safety as measured by the incidence of treatment emergent adverse events
时间窗: 12 weeks
Incidence of treatment emergent adverse events as compared to placebo.
次要结局
- Efficacy as measured by Investigator Global Assessment (IGA)(12 weeks)
- Efficacy as measured by non-inflammatory lesion counts(12 weeks)
研究者
研究点 (10)
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