NCT00098358Unknown2 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Clinical Proof of Concept Study of Zileuton IR in Patients With Moderate to Severe Facial Acne Vulgaris
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 90
- 试验地点
- 24
- 主要终点
- Change in number of inflammatory lesions
研究概览
简要总结
Tissue inflammation is a major component of the acne disease process. Leukotriene B4 (LTB4) is thought to be a major player in the development of tissue inflammation. Synthesis of LTB4 is controlled by the enzyme 5-lipoxygenase. Zileuton blocks the activity of 5-lipoxygenase. This study will test the safety and efficacy of zileuton in the treatment of facial acne.
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
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe facial acne vulgaris
- •20 to 60 facial inflammatory lesions
- •10 to 200 facial non-inflammatory lesions
- •No more than 3 facial nodular cystic lesions
排除标准
- •Uncontrolled systemic disease
- •Use of systemic or topical acne therapy within 14 days of study
- •Use of systemic retinoids within past 2 years
- •Skin diseases that interfere with acne counts
- •Active liver disease
- •Screening elevations in liver function tests
- •Positive serology for hepatitis B or C
- •Use of theophylline, warfarin, or propranolol within 7 days of study
- •Use of Singulair or Accolate within 14 days of study
- •Female patients who are pregnant or nursing
结局指标
主要结局
Change in number of inflammatory lesions
次要结局
- Physician's global assessment scale
- Change in number of non-inflammatory lesions
- Change in total numbers of lesions
- Change in sebum production
研究者
研究点 (24)
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