A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Tretinoin Cream 0.025% and RETIN-A® Cream 0.025% in the Treatment of Acne Vulgaris
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 1,030
- 试验地点
- 1
- 主要终点
- Demonstration of Bioequivalence
研究概览
简要总结
The bioequivalence and safety of Tretinoin Cream 0.025% (Taro Pharmaceuticals U.S.A, Inc.) and RETIN-A® (Tretinoin) Cream 0.025% in the treatment of acne vulgaris.
详细描述
A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Tretinoin Cream 0.025% (Taro Pharmaceuticals U.S.A) and RETIN-A® (Tretinoin) Cream 0.025% and Both 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
- Single (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 ≤ 40 years with a clinical diagnosis of acne vulgaris.
- •Subjects who are 18 years of age or older (up to the age of 40) must have provided IRB approved written informed consent. Subjects 12 to 17 years of age, inclusive, must have provided IRB approved written assent
- •Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA)
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 tretinoin, retinoids, or any of the study medication ingredients.
- •Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
研究组 & 干预措施
Tretinoin Cream 0.025%
The study medication will be self-applied topically on the affected areas of the face lightly, once daily at bedtime, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.
干预措施: Tretinoin Cream 0.025% (Drug)
RETIN-A® (Tretinoin) Cream 0.025%
The study medication will be self-applied topically on the affected areas of the face lightly, once daily at bedtime, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.
干预措施: Tretinoin Cream 0.025% (Drug)
Placebo Control
The study medication will be self-applied topically on the affected areas of the face lightly, once daily at bedtime, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.
干预措施: Tretinoin Cream 0.025% (Drug)
结局指标
主要结局
Demonstration of Bioequivalence
时间窗: Baseline to Week 12
To evaluate the percentage change in the inflammatory and non-inflammatory lesion counts
次要结局
未报告次要终点