NCT00671749已完成4 期
A Clinical Assessment of Combination Therapy With Differin® Gel, 0.3% With Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Percent Change From Baseline in Total Lesion Counts
研究概览
简要总结
This study is to determine the efficacy and safety of 12 week treatment with Differin® Gel 0.3% applied in the evening, in combination with Duac® (Clindamycin/Benzoyl Peroxide Gel) applied in the morning, in Subjects with Acne vulgaris.
详细描述
Same as above.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 on the face;
- •Subjects with a minimum of 15 and a maximum of 100 non-inflammatory lesions (open and closed comedones) on the face, excluding the nose;
- •Subject has a Global Severity Assessment
排除标准
- •Subjects with more than three nodulo-cystic lesions
研究组 & 干预措施
Study Treatment
Experimental
adapalene gel, 0.3%
Other Names:
Differin® Gel, 0.3% Applied once daily at bedtime
clindamycin/benzoyl peroxide gel
Other Names:
Duac® Gel Applied once daily in the morning
干预措施: adapalene gel, 0.3% (Drug)
Study Treatment
Experimental
adapalene gel, 0.3%
Other Names:
Differin® Gel, 0.3% Applied once daily at bedtime
clindamycin/benzoyl peroxide gel
Other Names:
Duac® Gel Applied once daily in the morning
干预措施: clindamycin/benzoyl peroxide gel (Drug)
结局指标
主要结局
Percent Change From Baseline in Total Lesion Counts
时间窗: 6 and 12 weeks
次要结局
- Worst Post Baseline Tolerability Assessment - Erythema(12 weeks)
- Global Severity Assessment Success(6 and 12 weeks)
- Worst Post Baseline Tolerability Assessment - Scaling(12 weeks)
- Worst Post Baseline Tolerability Assessment - Dryness(12 weeks)
- Worst Post Baseline Tolerability Assessment - Burning/Stinging(12 weeks)
- Global Assessment of Improvement From Baseline(12 weeks)
研究者
研究点 (4)
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