A Phase III, Multicenter, Randomized, Double Blind-Double Dummy Study, To Evaluate Efficacy And Safety Of Treatment With Azithromycin, Microspheres, Oral Powder For Suspension, 2 G, In One Administration A Week, For 8 Weeks, Compared With Treatment With Minocycline Capsules, 100 Mg Die For 8 Weeks, In Outpatients With Moderate To Severe Inflammatory Acne.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Change From Baseline to End of Treatment in Global Acne Grading System (GAGS) Score
研究概览
简要总结
The primary objective is to evaluate the clinical efficacy of azithromycin microspheres treatment in outpatients with moderate to severe inflammatory acne compared with first line treatment minocycline after 8 weeks of therapy
详细描述
The study prematurely discontinued on the February 1, 2008 due to slow enrollment.It should be noted that safety concerns have not been seen in this study and have not factored into this decision.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male and female, > 16 years of age, with diagnosis of acne papulo-pustular, moderate (19-30 GAGS score) to severe (31-33 GAGS score)
排除标准
- •pregnancy, gastrointestinal and endocrinological disease, specific systemic disease, hormonal contraceptives, isotretinoin, topic drugs for acne (except detergent allowed)
研究组 & 干预措施
Treatment Group A
干预措施: Azithromycin microspheres (Drug)
Treatment Group A
干预措施: minocycline-placebo capsules (Drug)
Treatment Group B
干预措施: Azithromycin microspheres-placebo (Drug)
Treatment Group B
干预措施: Minocycline capsules, (Drug)
结局指标
主要结局
Change From Baseline to End of Treatment in Global Acne Grading System (GAGS) Score
时间窗: Baseline, Week 8 End of Treatment (EOT)
GAGS used to assess 6 locations on face/chest/upper back; factor for each location based on surface area, distribution, density of pilosebaceous units. Locations graded separately 0 - 4 (hi). Global score factored based on summing of local scores. Change: (Global) score at observation minus (global) score at baseline.
Change From Baseline to End of Treatment (EOT) in Global Acne Grading System (GAGS) Score - Per Protocol Population
时间窗: Baseline, Week 8 EOT
GAGS used to assess 6 locations on face/chest/upper back; factor for each location based on surface area, distribution, density of pilosebaceous units. Locations graded separately 0 - 4 (hi). Global score factored based on summing of local scores. Change: (Global) score at observation minus (global) score at baseline.
次要结局
- Change From Baseline in Global Acne Grading System (GAGS) Score(Baseline, Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT)
- Improvement of Global Acne Grading System (GAGS) Score(Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT)
- Change From Baseline in Acne Graded by Leeds Technique(Baseline, Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT)