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
- 1,668
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Achieved Success Rate 0 (Clear) or 1 (Almost Clear) on the Investigator Global Assessment (IGA) Scale at Week 12 (Last Observation Carried Forward)
研究概览
简要总结
This was a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations were 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 participant should remain the same during the study.
The primary objective was 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
- Double (Participant, Investigator)
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
- 未提供
研究组 & 干预措施
Gel Vehicle
Participants were treated with gel vehicle topically daily in the evening for 12 Weeks.
干预措施: Gel Vehicle (Drug)
Adapalene/Benzoyl Peroxide Gel
Participants were treated with adapalene 0.1 % [weight by weight (W/W)]/benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening for 12 Weeks.
干预措施: Adapalene/Benzoyl Peroxide (Drug)
Adapalene Gel, 0.1%
Participants were treated with 0.1% of adapalene gel topically daily in the evening for 12 Weeks.
干预措施: Adapalene Gel, 0.1% (Drug)
Benzoyl Peroxide Gel 2.5%
Participants were treated with 2.5% of benzoyl peroxide gel topically daily in the evening for 12 Weeks.
干预措施: Benzoyl Peroxide Gel 2.5% (Drug)
结局指标
主要结局
Percentage of Participants Who Achieved Success Rate 0 (Clear) or 1 (Almost Clear) on the Investigator Global Assessment (IGA) Scale at Week 12 (Last Observation Carried Forward)
时间窗: At Week 12
Success rate was defined as percentage of participants who achieved "Clear" or "Almost Clear" score on the IGA scale. IGA scale consisted of 5 grades (0-4) among which 0 = Clear (Minor, residual discoloration, no erythema or induration/papulation, no oozing/crusting), 1 = Almost clear (Trace, faint pink erythema with almost no induration/papulation and no oozing/crusting), 2 = Mild (Faint pink erythema with mild induration/papulation and no oozing/crusting), 3 = Moderate (Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting.), 4 = Severe (Deep/bright red erythema with severe induration/papulation with oozing/crusting). All missing values were imputed by LOCF.
Change in Inflammatory Lesion Count From Baseline to Week 12
时间窗: Baseline to Week 12
Change in inflammatory lesion count from baseline to week 12 was reported. All missing values were imputed by LOCF.
Change in Noninflammatory Lesion Count From Baseline to Week 12
时间窗: Baseline to Week 12
Change in noninflammatory lesion count from baseline to week 12 was reported. All missing values were imputed by LOCF.
次要结局
- Percent Change From Baseline in Inflammatory Lesion Counts at Week 12(Baseline, Week 12)
- Percent Change From Baseline in Noninflammatory Lesion Counts at Week 12(Baseline, Week 12)
- Percent Change From Baseline in Total Lesion Counts at Week 12(Baseline, Week 12)