Evaluation of Relapse, Efficacy and Safety of Long-term Treatment With Oracea® Capsules Compared to Placebo After an Initial 12 Week Treatment Regimen With Oracea® and MetroGel® 1% in Adults With Rosacea
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 235
- 试验地点
- 10
- 主要终点
- Period 2: Number of Subjects Who Relapsed
研究概览
简要总结
The purpose of this study is to assess relapse, efficacy and safety in subjects with rosacea during long-term treatment with either Oracea® or placebo, after an initial 12-week regimen of Oracea® and MetroGel® 1%.
详细描述
Adult subjects with moderate to severe papulopustular rosacea will receive Oracea® and MetroGel® 1% once daily during phase 1 (baseline to week 12) of the study. Subjects will be eligible to enter phase 2 of the study based upon improvements in the Investigator's Global Assessment (IGA) score. During phase 2, subjects will receive either Oracea® or placebo once daily for up to an additional 40 weeks. Subjects who relapse during phase 2 will be discontinued from the study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is male or female aged 18 to 80 years inclusive.
- •Subject with papulopustular rosacea (11 to 40 papules or pustules) and an IGA of moderate or severe.
- •For subjects using medications to treat a concurrent medical condition, type and dose must have been stable for at least 90 days prior to study entry.
排除标准
- •Female subjects who are pregnant, nursing or planning a pregnancy during the study.
- •Subject has any other active dermatological condition on the face that may interfere with the conduct of the study.
- •Subject uses or has recently used any medication which may interfere with the absorption, distribution, or elimination of study medications, or may interfere with the assessments of efficacy or safety of the study medications.
- •Subject has a known allergy to any of the components of the study products, and/or a known hypersensitivity to tetracyclines or metronidazole.
研究组 & 干预措施
Placebo
Subjects will receive placebo during phase 2 (week 12 - week 52)
干预措施: Placebo (Drug)
Doxycycline and Metronidazole
Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
干预措施: Doxycycline (Drug)
Doxycycline and Metronidazole
Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
干预措施: Metronidazole (Drug)
Doxycycline
Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) during phase 2 (week 12 - week 52)
干预措施: Doxycycline (Drug)
结局指标
主要结局
Period 2: Number of Subjects Who Relapsed
时间窗: Period 2 (40 weeks)
Subjects who relapsed during phase 2 were discontinued. Relapse was defined as meeting any one of the following criteria: * A return to the baseline lesion count * A return to the baseline IGA score * The investigator determines that a change in rosacea treatment is warranted due to the subject's clinical condition. The numbers reported here are accumulative numbers for each arm.
次要结局
- Period 2: Investigator's Global Assessment Success(Period 2 (40 weeks))
- Period 2: Inflammatory Lesion Count(Period 2 (40 Weeks))
- Period 2: Clinician's Erythema Assessment(Period 2 (40 Weeks))