NCT02100527撤回2 期
A Phase 2a Randomized, Double-blind, Placebo-Controlled Study To Evaluate The Safety, Tolerability And Effects Of PF-05175157 On Moderate To Severe Acne Vulgaris In Adult Subjects
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Pfizer
- 主要终点
- Safety and tolerability
研究概览
简要总结
This is a 6 week study to characterize the safety, tolerability and effects of PF-05175157 administered for 6 weeks in subjects with 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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males 18 years or older diagnosed with moderate to severe acne vulgaris who are otherwise healthy.
- •Normal spirometry at screening (FEV1 and FVC (Forced Vital Capacity)at least 80% predicted).
- •Minimum of 20 inflammatory lesions on the face.
- •Willing to discontinue other acne treatments prior to and during the study period through follow-up.
排除标准
- •Subjects with active nodulocystic acne.
- •Subjects unwilling to comply with lifestyle guidelines, commit to study visits, and perform study procedures.
- •History of dry eye or other known disease that affects the sclera or cornea.
- •History of pulmonary disease or inability to adequately perform testing.
研究组 & 干预措施
PF-05175157
Experimental
干预措施: PF-05175157 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: Weeks 2, 4, and 6
Physical examination, pulmonary function testing, adverse event monitoring, ECGs, vital signs, laboratory tests
次要结局
- Sebum measurements(Weeks 2, 4, and 6)
- Pharmacokinetics of PF-05175157(Weeks 2, 4, and 6)
研究者
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