A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Glenmark Generics, Ltd) to the Marketed Product BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5% (Valeant Pharmaceuticals, US) in the Treatment of Acne Vulgaris.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,100
- 试验地点
- 15
- 主要终点
- Mean Percent Change in the Number of Inflamed Lesions (Papules/Pustules)
研究概览
简要总结
This is a randomized, double-blind, multiple-site, placebo-controlled, parallel-group study, designed to compare the efficacy and safety of generic Clindamycin 1%/ Benzoyl peroxide 5% topical gel (Glenmark Generics, Ltd), and the marketed product BenzaClin® Topical Gel, Clindamycin 1%/ Benzoyl peroxide 5% (Valeant Pharmaceuticals, US) 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
- •Male or non-pregnant, non-lactating female, ≥12 and ≤40 years of age with a clinical diagnosis of acne vulgaris.
- •Have facial acne with: ≥20 facial inflammatory lesions (papules and pustules) and ≥25 non-inflammatory lesions (open and closed comedones), and ≤2 nodulocystic lesions (nodules and cysts) and have an IGA score of 2, 3 or 4.
排除标准
- •Subject has more than 2 facial nodular lesions; any nodules present will be documented but not included in the inflammatory lesion count for analysis.
- •Subject has active cystic acne.
- •Subject has acne conglobata.
- •Subjects with excessive facial hair such as beards, sideburns, moustaches, etc. that would interfere with the diagnosis or assessment of acne.
研究组 & 干预措施
Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel
apply a thin layer of gel to the face
干预措施: Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Drug)
BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%
apply a thin layer of the gel to the face
干预措施: BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5% (Drug)
Placebo topical gel
apply a thin layer of the gel to the face
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Percent Change in the Number of Inflamed Lesions (Papules/Pustules)
时间窗: Baseline and 10 Weeks
The number of inflammatory lesions (papules and pustules) count between the treatment groups were estimated.
Mean Percent Change in the Number of Non-inflamed Lesions (Open and Closed Comedones)
时间窗: Baseline and 10 Weeks
The number of non-inflamed lesions (open and closed comedones) count between treatment groups were estimated.
次要结局
未报告次要终点