NCT01493947已完成3 期
Efficacy and Safety of CD5024 1% Cream Versus Metronidazole 0.75% Cream in Subjects With Papulopustular Rosacea Over 16 Weeks Treatment, Followed by a 36-week Extension Period.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 962
- 试验地点
- 2
- 主要终点
- Percent Change in Inflammatory Lesions From Baseline to Week 16
研究概览
简要总结
Study objectives:
- To compare efficacy and safety of Ivermectin 1% cream versus metronidazole 0.75% cream in subjects with papulopustular rosacea after 16-week topical treatment.
- And to compare, for subjects initially successfully treated by 16 weeks treatment, Ivermectin 1 % cream versus metronidazole 0.75% cream during a 36-week extension period by assessing, the time of first relapse, the relapse rate, and the number of days free of treatment
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
- Single (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
- 否
入选标准
- •Subjects with papulopustular rosacea scored 3 (moderate) or 4 (severe) according to the Investigator Global Assessment (IGA),
- •Subjects with at least 15 but not more than 70 inflammatory lesions (papules and pustules) on the face.
排除标准
- •Subjects with particular forms of rosacea (rosacea conglobate, rosacea fulminant, isolated rhinophyma, isolated pustulosis of the chin) or other facial dermatoses that may be confounded with papulopustular rosacea, such as peri oral dermatitis, facial keratosis pilar, or seborrheic dermatitis and acne,
- •Subjects with rosacea with more than two nodules on the face.
研究组 & 干预措施
Ivermectin 1% cream
Experimental
干预措施: Ivermectin 1% cream (Drug)
Metronidazole 0.75% cream
Active Comparator
干预措施: Metronidazole 0.75% cream (Drug)
结局指标
主要结局
Percent Change in Inflammatory Lesions From Baseline to Week 16
时间窗: Baseline and Week 16
Efficacy of Ivermectin versus Metronidazole as determined by the percent change in inflammatory lesions after a 16-week treatment period
次要结局
未报告次要终点
研究者
研究点 (2)
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