NCT00988026Unknown4 期
Safety and Efficacy Comparison of Minocycline Microgranules vs Lymecycline in the Treatment of Mild to Moderate Acne. Randomized, Double Blind, Parallel and Prospective Clinical Trial for 8 Weeks
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- Darier
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Number of inflammatory and non-inflammatory acne lesions
研究概览
简要总结
This is a clinical trial to compare the benefits and possible adverse events of two antibiotic treatments for mild to moderate acne. It is expected that minocycline microgranules will be more effective than lymecycline with a better adverse events profile.
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 (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both gender
- •14 to 30 years old
- •Mild to moderate acne
- •Face localization
- •At least 20 non-inflammatory lesions OR
- •At least 15 inflammatory lesions OR
- •At least 30 total lesions AND
- •Less than 5 nodular lesions
排除标准
- •Patients younger than 14 or older than 30 years old
- •Less than 20 non-inflammatory lesions OR
- •Less than 15 inflammatory lesions OR
- •Less than 30 total lesions
- •Patients with severe acne
- •More than 5 nodular lesions OR
- •More than 50 inflammatory lesions OR
- •More than 125 total lesions
- •Pregnant women
- •Lactating women
研究组 & 干预措施
Minocycline 100 mg
Experimental
Minocycline
干预措施: Minocycline vs Lymecycline (Drug)
Lymecycline 300 mg
Active Comparator
Group B: Lymecycline
干预措施: Minocycline vs Lymecycline (Drug)
结局指标
主要结局
Number of inflammatory and non-inflammatory acne lesions
时间窗: 8 weeks
次要结局
- Incidence of local and systemic adverse events(8 weeks)
研究者
研究点 (1)
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