NCT00495313已完成4 期
Determine the Effects of COL-101 Administered Once Daily With Metronidazole Topical Gel, 1% Versus Doxycycline Hyclate 100 mg Administered Once Daily With Metronidazole Topical Gel, 1% in Patients With Moderate to Severe Rosacea
CollaGenex Pharmaceuticals7 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2007年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 试验地点
- 7
- 主要终点
- Change in total lesion count from Baseline at the study endpoint
研究概览
简要总结
To compare the safety and efficacy of two treatment regimens: 1) COL-101 and metronidazole gel 1%; 2) Doxycycline hyclate 100 mg and metronidazole gel 1%
详细描述
Compare the safety and efficacy of two treatment regimens: 1) COL-101 and metronidazole gel 1%; 2) Doxycycline hyclate 100 mg and metronidazole gel 1%
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •8-40 total lesions
- •telangiectasia
排除标准
- •non-pregnant, non-lactating
- •achlorhydric
- •gastric by-pass surgery
- •allergy to study medications
- •drug/alcohol abuse
- •use of proton pump inhibitors
研究组 & 干预措施
Cohort 1: doxycycline
Active Comparator
Vibramycin plus metronidazole
干预措施: doxycycline (Drug)
Cohort 2
Active Comparator
Oracea® delayed release plus metronidazole
干预措施: doxycycline (Drug)
结局指标
主要结局
Change in total lesion count from Baseline at the study endpoint
时间窗: 16 weeks
次要结局
- Change in Investigator's Global Assessment from Baseline at the study endpoint(16 weeks)
- Change in Clinician's Erythema Assessment score from Baseline at the study endpoint(16 weeks)
- Change in total lesion count (papules + pustules + nodules) from Baseline at each visit(4 weeks, 8 weeks, 12 weeks)
研究者
研究点 (7)
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