NCT00126399已完成3 期
A Clinical Trial to Determine the Effects of 40 Mg Doxycycline Versus a Placebo Control for the Treatment of Rosacea
CollaGenex Pharmaceuticals0 个研究点目标入组 528 人开始时间: 2004年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 528
- 主要终点
- Change in total inflammatory lesion count
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of 40 mg doxycycline controlled-release capsules administered once daily for the treatment of rosacea compared with a placebo.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main Inclusion Criteria:
- •Healthy patients with rosacea
- •Males and females ≥18 years of age
- •10 to 40 papules and pustules and ≤2 nodules
- •Score of 2 to 4 on the IGA
- •Presence of telangiectasia
- •Moderate to severe erythema
排除标准
- •Use of topical acne treatments or topical or systemic antibiotics
- •Use of systemic retinoids within 90 days of baseline
- •Use of an investigational drug within 90 days of baseline
- •Pregnant or nursing women
- •Women of childbearing potential not using an adequate form of contraception
- •Change in method of contraception within 4 months of baseline
- •Known hypersensitivity to tetracyclines
- •Surgeries that bypass or exclude the duodenum or achlorhydria
结局指标
主要结局
Change in total inflammatory lesion count
次要结局
- Change from baseline in erythema scale scores
- change from baseline in the investigator's global assessment (IGA) score
- proportion of patients being clear or near-clear at endpoint
研究者
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