A Multi-Center, Randomized, Double-Blind, Parallel-Group Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel Compared With Adapalene Topical Gel, 0.1%; Benzoyl Peroxide Topical Gel, 2.5% and Topical Gel Vehicle in Subjects With Acne Vulgaris
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 1,670
- 试验地点
- 61
- 主要终点
- Changes in Noninflammatory Lesion Counts
研究概览
简要总结
This is a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations will be performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment evaluators and lesion counters must be trained and approved by Galderma. The evaluator of a subject should remain the same during the study.
The primary objective is to demonstrate the superiority in efficacy and assess safety of Adapalene/Benzoyl Peroxide Topical Gel (Adapalene/Benzoyl Peroxide Gel) versus Adapalene Topical Gel, 0.1% (Adapalene Monad); Benzoyl Peroxide Topical Gel, 2.5% (Benzoyl Peroxide Monad) and Topical Gel Vehicle (Gel Vehicle) in the treatment of acne vulgaris for up to 12 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A clinical diagnosis of acne vulgaris with facial involvement.
- •A minimum of 20 but not more than 50 Inflammatory lesions
- •A minimum of 30 but not more than 100 Noninflammatory lesions
- •A score of 3 (Moderate) on the Investigator's Global Assessment Scale.
排除标准
- •More than one acne nodule or any acne cyst.
- •Acne conglobata, acne fulminans, secondary acne, or severe acne.
- •Known previous participation in an Adapalene/Benzoyl Peroxide Topical Gel Trial.
- •Underlying diseases that require the use of interfering topical or systemic therapy.
- •Use of prohibited medications prior to the study unless appropriate washout period is documented
- •Use of hormonal contraceptives solely for control of acne
研究组 & 干预措施
1
Adapalene/Benzoyl Peroxide Topical Gel
干预措施: Adapalene/Benzoyl Peroxide (Drug)
2
Adapalene Topical Gel
干预措施: Adapalene (Drug)
3
Benzoyl Peroxide Topical Gel
干预措施: Benzoyl Peroxide (Drug)
4
Topical Gel Vehicle
干预措施: Topical Gel Vehicle (Drug)
结局指标
主要结局
Changes in Noninflammatory Lesion Counts
时间窗: from Baseline to week 12
Change in Noninflammatory Lesion Counts equals Week 12 Noninflammatory Lesion Count minus Baseline Noninflammatory Lesion Count
Success Rate on the Investigator's Global Assessment
时间窗: at week 12
Percentage of subjects rated "Clear" and "Almost Clear" on 5-point scale (0=clear; 4=severe)
Changes in Inflammatory Lesion Counts
时间窗: from Baseline to week 12
Changes in Inflammatory Lesion Counts equals Week 12 Inflammatory Lesion Counts minus Baseline Inflammatory Lesion Counts
次要结局
- Percent Change in Inflammatory Lesion Counts(at week 12)
- Percent Change in Noniflammatory Lesion Counts(at week 12)
- Percent Change in Total Lesion Counts(at week 12)