A Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-group Study, Comparing Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A, Inc.) to Aklief® Cream (US REFERENCE LISTED DRUG), Aklief Cream (REFERENCE PRODUCT) and Each Active Treatment 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
- 1,000
- 试验地点
- 1
- 主要终点
- Demonstrate the therapeutic equivalence, efficacy and safety of the Investigational Product
研究概览
简要总结
To demonstrate the efficacy, therapeutic equivalence and safety of Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A., Inc.) and US Reference Listed Drug, Canadian Reference Product over the placebo control in the treatment of acne vulgaris.
详细描述
A multi-center, double-blind, randomized, placebo-controlled, parallel-group study, comparing comparing Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A, Inc.) to Aklief® Cream (US REFERENCE LISTED DRUG), Aklief Cream (REFERENCE PRODUCT) and each active treatment to a placebo 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
- Triple (Participant, Care Provider, 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 must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3 or 4 as per the Investigator's Global Assessment (IGA).
- •Subjects must have ≥ 25 non-inflammatory lesions (i.e., open and closed comedones) AND ≥ 20 inflammatory lesions (i.e., papules and pustules) AND ≤2 nodulocystic lesions (i.e., nodules and cysts), at baseline on the face.
- •Subjects must be willing to refrain from using all other topical acne medications or antibiotics for acne vulgaris during the 12-week treatment period, other than the investigational product.
排除标准
- •Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
- •Subjects with a history of hypersensitivity or allergy to Trifarotene, retinoids and/or any of the study medication ingredients.
- •Subjects with excessive facial hair (e.g. beards, sideburns, mustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris.
- •Subjects with a baseline irritation score of 3 = severe (marked, intense).
研究组 & 干预措施
Trifarotene Cream 0.005%
A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime.
干预措施: Trifarotene Cream 0.005% (Drug)
AKLIEF® Cream (Trifarotene 0.005%) US REFERENCE LISTED DRUG
A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime.
干预措施: AKLIEF® Cream (Trifarotene 0.005%) US REFERENCE LISTED DRUG (Drug)
AKLIEF® Cream (Trifarotene 50 mcg/g) CANADIAN REFERENCE PRODUCT
A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime.
干预措施: AKLIEF® Cream (Trifarotene 50 mcg/g) CANADIAN REFERENCE PRODUCT (Drug)
Placebo Control
A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime.
干预措施: Placebo (Drug)
结局指标
主要结局
Demonstrate the therapeutic equivalence, efficacy and safety of the Investigational Product
时间窗: Baseline to Week 12
Percentage change in the inflammatory (papules and pustules) \& non-inflammatory (open and closed comedones) of the lesion counts.
次要结局
未报告次要终点