A Multiple-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study Comparing Tazarotene Cream 0.1% to Tazorac® (Tazarotene Cream 0.1%) 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
- 1,077
- 主要终点
- Change in inflammatory lesion counts
研究概览
简要总结
The purpose of this study is to evaluate the therapeutic equivalence and safety of Tazarotene Cream 0.1% and Tazorac® (tazarotene cream 0.1%).
详细描述
The purpose of this study is to evaluate the therapeutic equivalence and safety of Tazarotene Cream 0.1% and Tazorac® (tazarotene cream 0.1%) in the treatment of acne vulgaris and to demonstrate the superiority of the 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.
- •Subjects aged 18 years and older must have provided written consent. Subjects aged 12 to 17 years must have provided written assent accompanied by written consent from their legally acceptable representative. All subjects or their legally acceptable representatives must sign Health Insurance Portability and Accountability Act authorization.
- •Must have a minimum of ≥ 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.
- •Have a history of hypersensitivity or allergy to tazarotene, retinoids and/or any of the study medication ingredients.
- •Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris.
研究组 & 干预措施
Tazarotene Cream 0.1%
Tazarotene Cream 0.1% (Taro Pharmaceuticals Inc.)
干预措施: Tazarotene Cream 0.1% (Drug)
Tazorac®
Tazorac® (tazarotene cream 0.1%) (Allergan LLC)
干预措施: Tazorac® (Drug)
Placebo
Placebo (Vehicle of the test product) (Taro Pharmaceuticals Inc.)
干预措施: Placebo (Drug)
结局指标
主要结局
Change in inflammatory lesion counts
时间窗: Week 12
Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts
Change in non-inflammatory lesion counts
时间窗: Week 12
Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts
次要结局
- Clinical response of success(Week 12)