NCT04321070已完成1 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- Demonstration of Bioequivalence
研究概览
简要总结
Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris
详细描述
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
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 ≤ 40years 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 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 adapalene, retinoids and/or any of the study medication ingredients, have a known hypersensitivity to adapalene and benzoyl peroxide and its excitements.
研究组 & 干预措施
Clindamycin Phosphate
Experimental
Topical, once daily, for 84 days.
干预措施: Clindamycin Phosphate (Drug)
Clindamycin Phosphate RLD
Active Comparator
Topical, once daily, for 84 days
干预措施: Clindamycin Phosphate RLD (Drug)
Vehicle of the test product
Placebo Comparator
Topical, once daily, for 84 days
干预措施: Placebos (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
研究者
研究点 (1)
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