Randomized, Open-label Study to Evaluate the Efficacy and Safety of Doryx Tablets Compared to Doxycycline Hyclate in the Treatment of Acne Vulgaris.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Successful Outcome According to Investigator's Global Assessment (IGA)
研究概览
简要总结
Randomized, multi-center, open label, active-comparator study to compare the efficacy and tolerability of Doryx Delayed Release Tablets to doxycycline hyclate in patients with moderate to severe acne vulgaris.
详细描述
Efficacy of Doryx Delayed Release Tablets to doxycycline hyclate will be assessed using an Investigator's Global Assessment (IGA) score and the absolute change from baseline to 12 weeks in inflammatory lesion count in patients with moderate to severe facial acne vulgaris. Additionally, the absolute change from baseline to 12 weeks in non-inflammatory lesions count of Doryx Delayed Release Tablets compared to doxycycline hyclate will be evaluated.
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
- None
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
- •Must be 12 years of age or older.
- •Has a diagnosis of facial acne vulgaris with no more than two nodules on the face.
排除标准
- •Is allergic to tetracycline-class antibiotics or to any ingredient in the study medication.
- •Has a history of pseudomembranous colitis or antibiotic-associated colitis.
- •Has a history of hepatitis or liver damage or renal impairment.
研究组 & 干预措施
Doxycycline hyclate (Doryx)
干预措施: Doxycycline hyclate (Doryx) (Drug)
Doxycycline hyclate
干预措施: Doxycycline hyclate (Drug)
结局指标
主要结局
Successful Outcome According to Investigator's Global Assessment (IGA)
时间窗: baseline and 12 weeks
The Investigator's Global Assessment (IGA) was performed at baseline and at 12 weeks. The IGA score is based on a 5-point acne severity scale from zero (clear) to 4 (severe). Successful outcome is at least a 2-point reduction in IGA score from baseline to 12 weeks.
Change From Baseline in Inflammatory Acne Lesion Count on the Face at 12 Weeks
时间窗: baseline and 12 weeks
Acne lesions fall into 2 groups: inflammatory and non-inflammatory. The number of inflammatory acne lesions on the face was measured at baseline and after 12 weeks. The difference (change) was calculated.
次要结局
- Change From Baseline in Non-inflammatory Acne Lesion Count on the Face at 12 Weeks(baseline and 12 weeks)