NCT02929719已完成1 期
A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Test Gel, 5% to ACZONE Gel, 5% and Both Active Treatment to a Placebo Control in the Treatment of Acne Vulgaris
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 1,134
- 主要终点
- Change in inflammatory lesion count
研究概览
简要总结
Therapeutic equivalence and safety study
详细描述
To evaluate the therapeutic equivalence and safety of Test formulation and marketed Reference Listed Drug (RLD).
To demonstrate the superiority of efficacy of the Test and Reference products over the placebo control in the treatment.
To compare the safety of Test, Reference and Placebo treatments.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or non pregnant female aged ≥ 12 and ≤ 40years with a clinical diagnosis of acne vulgaris
- •Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA) (per Table 1 below)
排除标准
- •Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
研究组 & 干预措施
Test Gel 5%
Experimental
Topical, twice daily on the face for 84 days.
干预措施: Test. (Drug)
ACZONE Gel 5%
Active Comparator
Topical, twice daily on the face for 84 days
干预措施: Aczone Gel 5% (Drug)
Placebo Gel
Placebo Comparator
Topical, twice daily on the face for 84 days
干预措施: Placebo (Drug)
结局指标
主要结局
Change in inflammatory lesion count
时间窗: baseline to week 12 (study day 84)
Change in non-inflammatory lesion count
时间窗: baseline to week 12 (study day 84)
次要结局
未报告次要终点
研究者
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