NCT00841776已完成4 期
Comparative Antimicrobial Efficacy of Two Topical Acne Therapies for the Treatment of Moderate to Moderately Severe Facial Acne Vulgaris
Stiefel, a GSK Company2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2007年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Median Change in Total Propionibacterium Acne (P.Acne) Counts
研究概览
简要总结
The purpose of the study is to determine the development of microbial resistance when using one of two topical acne therapies for the treatment of facial acne vulgaris.
详细描述
To investigate the development of microbial resistance when using one of two topical acne therapies for the treatment of moderate to moderately severe facial acne vulgaris. Clinical efficacy and tolerability will be assessed.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatient at least 12 years of age. Female subjects of childbearing potential must have a negative urine pregnancy test result at baseline and practice a reliable method of contraception throughout the study.
- •Mild to moderate facial acne vulgaris
- •Able to understand the requirements of the study and sign informed consent/HIPAA authorization forms. Subjects under the legal age of consent in the state where the study is conducted must also have the written, informed consent of a parent or legal guardian.
排除标准
- •Female subjects who are pregnant (positive urine pregnancy test), breast feeding or who are of childbearing potential and not practicing a reliable method of birth control
- •Allergy or sensitivity to any component of the test medication
- •Known hypersensitivity to to any component of the investigational formulations
- •Known history of enteritis (regional enteritis, ulcerative colitis, pseudomembranous colitis, or antibiotic-associated colitis
- •Beards or sideburns
- •Skin disease/disorder that might interfere with the diagnosis or evaluation of acne vulgaris
- •Evidence of recent alcohol or drug abuse
- •Participation in an investigational drug study within 30 days of the baseline visit
研究组 & 干预措施
Duac gel
Active Comparator
Clindamycin and benzoyl peroxide gel
干预措施: Duac (Drug)
Ziana gel
Active Comparator
Clindamycin and tretinoin gel
干预措施: Ziana gel (Drug)
结局指标
主要结局
Median Change in Total Propionibacterium Acne (P.Acne) Counts
时间窗: Baseline, Weeks 2, 4, 8, 12, & 16
Median change in total colony forming units of propionibacterium acne (P.acne) will be counted.
次要结局
- Median Change in Clindamycin Resistant P. Acne.(Baseline, Weeks 2, 4, 8, 12, 16)
- Median Change in Erythromycin-resistant P. Acne Counts(Baseline, Weeks 2, 4, 8, 12, and 16)
- Median Change in Total Acne Lesions(Baseline, Weeks 2, 4, 8, 12, and 16)
- Median Change in Inflammatory Acne Lesion Counts(Baseline, Weeks 2, 4, 8, 12, and 16)
- Median Change in Noninflammaotry Acne Counts(Baseline, Weeks 2, 4, 8, 12, and 16)
研究者
研究点 (2)
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