NCT00469755已完成4 期
A Comparison of Differin® Gel, 0.1% vs. Tazorac® Cream, 0.1% vs. Differin® Gel, 0.1% 6-week Treatment Switched to Tazorac® Cream, 0.1% 6-week Treatment in Patients With Acne Vulgaris
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 302
- 试验地点
- 12
- 主要终点
- Efficacy - total lesion counts
研究概览
简要总结
To determine the efficacy and safety of 12 weeks of treatment with Differin Gel, 0.1% compared to 12 weeks of treatment with Tazorac Cream, 0.1% and compared to 6 weeks treatment with Differin Gel, 0.1% followed by 6 weeks of treatment with Tazorac Cream
详细描述
Same as above.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face
- •Subjects with a minimum of 15 and a maximum of 100 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose
排除标准
- •Subjects with more than 3 nodulo-cystic lesions
研究组 & 干预措施
1
Active Comparator
Differin® Gel, 0.1% for 12 weeks
干预措施: Adapalene Gel, 0.1% (Drug)
2
Active Comparator
Tazorac® Cream, 0.1% for 12 weeks
干预措施: Tazarotene Cream, 0.1% (Drug)
3
Active Comparator
Differin® Gel, 0.1% for 6 weeks switched to Tazorac® Cream, 0.1% for 6 weeks
干预措施: Adapalene Gel, 0.1% + Tazarotene Cream, 0.1% (Drug)
结局指标
主要结局
Efficacy - total lesion counts
时间窗: 12 weeks
次要结局
- Safety - tolerability assessments and adverse event reporting(12 weeks)
研究者
研究点 (12)
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