A Multi Center Double Blind Randomized Placebo Controlled Parallel Group Study Comparing Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% to Onexton™ Gel and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 844
- 主要终点
- Demonstration of Bioequivalence
研究概览
简要总结
The objectives of this study are to evaluate the therapeutic equivalence and safety.
详细描述
The objectives of this study are to evaluate the therapeutic equivalence and safety of the test product Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% to the reference product Onexton™ Gel (Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%) in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of these test and reference products over the placebo control.
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
- 否
入选标准
- •Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
- •Must have a minimum ≥ 25 non-inflammatory lesions and ≥ 20 inflammatory lesions and ≤ 2 nodulocystic lesions at baseline on the face.
- •Must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment.
排除标准
- •Female subjects who are pregnant, nursing or planning to become pregnant during study participation.
- •A history or presence of Crohn's disease, ulcerative colitis, regional enteritis, or antibiotic-associated colitis.
- •A history of hypersensitivity or allergy to clindamycin, benzoyl peroxide and/or any of the study medication ingredients and its excipients.
研究组 & 干预措施
Clindamycin and BPO Gel 1.2%/3.75%
Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% applied to the face once daily for 84 days.
干预措施: Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% (Drug)
Onexton™ Gel
Onexton™ Gel (Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%) applied to the face once daily for 84 days.
干预措施: Onexton™ Gel (Drug)
Placebo
Placebo (vehicle of the test product) applied to the face once daily for 84 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Demonstration of Bioequivalence
时间窗: Week 12
Demonstration of Bioequivalence in percent change in inflammatory and non-inflammatory lesion counts
次要结局
- Clinical response of success(Week 12)