A Randomized, Double-Blind, Multiple Center Placebo Controlled Study Comparing Taro Product to RLD and Both 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
- 1,260
- 试验地点
- 1
- 主要终点
- Demonstration of Bioequivalence
研究概览
简要总结
This study is to evaluate the therapeutic equivalence and safety of Taro Product to RLD in the treatment of acne vulgaris.
详细描述
The study objectives are to evaluate the therapeutic equivalence and safety of Taro Product to RLD in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy 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 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; this written assent must be accompanied by an IRB approved written informed consent from the Subject's legally acceptable representative (i.e., parent or guardian).
- •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 known hypersensitivity to clindamycin or lincomycin and/or any ingredients in the study drugs.
- •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
CLPG Topical Gel 1%
Clindamycin Phosphate Topical Gel 1%, applied to the face twice a day for 84 days.
干预措施: CLPG Topical Gel 1% (Drug)
Clindamycin Phosphate Topical Gel 1%
Clindamycin Phosphate Topical Gel 1%, applied to the face twice a day for 84 days.
干预措施: Clindamycin (Drug)
Vehicle of the test product
Placebo (vehicle of the test product), applied to the face twice a day 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
未报告次要终点