Comparative Efficacy and Safety of Benzoyl Peroxide Used in Combination With Clindamycin vs. Benzoyl Peroxide Used in Combination With Clindamycin and Doxycycline in the Treatment of Moderate Acne
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Percent Change in Inflammatory Acne Lesions From Baseline to Week 16
研究概览
简要总结
To compare the efficacy and safety of Benzoyl peroxide used in combination with clindamycin vs. Benzoyl peroxide used in combination with clindamycin and doxycycline in the treatment of moderate acne
详细描述
To compare the efficacy and safety of Benzoyl peroxide used in combination with clindamycin vs. Benzoyl peroxide used in combination with clindamycin and doxycycline once daily in the treatment of moderate acne
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
- Single (Investigator)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects with acne vulgaris . Able to understand the requirements of the study and sign informed consent/HIPAA authorization forms.
排除标准
- •Known hypersensitivity to any of the components of the study drugs or used of prohibited medications or any medical condition that contraindicate the subject's participation in the clinical study
研究组 & 干预措施
BPO with clindamycin foam
Benzoyl peroxide (BPO) wash with clindamycin foam
干预措施: Benzoyl peroxide with clindamycin (Drug)
BPO + clindamycin foam + doxycycline
Benzoyl peroxide (BPO) wash with clindamycin foam and doxycycline capsules
干预措施: Benzoyl peroxide with clindamycin and doxycycline (Drug)
结局指标
主要结局
Percent Change in Inflammatory Acne Lesions From Baseline to Week 16
时间窗: Baseline, Week 16
Percent change from baseline to week 16 in inflammatory acne lesions (pustules/papules)(chest and back)
Percent (%) Change in Non-inflammatory Acne Lesions From Baseline to Week 16.
时间窗: Baseline, Week 16
Percent change in Non-inflammatory acne lesions (whiteheads and blackheads)(chest and back) from baseline to week 16.
Percent Change in Total Acne Lesion Counts From Baseline to Week 16
时间窗: Baseline, Week 16
Percent change from baseline to week 16 in total acne lesions (inflammatory + non-inflammatory)
Change in Investigator Global Assessment (IGA)
时间窗: Baseline, Weeks 4, 8,12, and 16
Change in Investigator Global Assessment (IGA) Average values chest and back. IGA scale: 0 - Clear 0.5 - Clear/almost clear 1. Almost Clear 1.5- Almost Clear/Mild 2. Mild 2.5- Mild/Moderate 3. Moderate 3.5- Moderate/Severe
次要结局
- Percent (%) Change in Inflammatory Lesion Counts (Chest and Back) From Baseline to Week 12(Baseline, Week 12)
- Percent Change in Non-inflammatory Lesions (Chest and Back) From Baseline to Week 12(Baseline, Week 12)
- Percent Change in Total Lesions (Chest and Back) From Baseline to Week 12(Week 12)
- Percentage of Particpants With IGA Score at Week 16(Baseline, Week 16)