A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both Active Treatments to a Vehicle Control in the Treatment of Acne Vulgaris
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,110
- 试验地点
- 1
- 主要终点
- Change in Inflammatory Lesion Counts
研究概览
简要总结
A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both Active Treatments to a Vehicle Control in the Treatment of Acne Vulgaris
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 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
Test
Tazarotene Cream 0.1% (Fougera Pharmaceuticals Inc.)
干预措施: Tazarotene Cream 0.1% (Drug)
Reference
TAZORAC® (tazarotene) Cream, 0.1% (Allergan, Inc.)
干预措施: Tazorac® (Drug)
Placebo
Placebo (Vehicle of test product) (Fougera 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)