NCT01301586Unknown1 期
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE SAFETY AND EFFICACY OF A NOVEL ORAL ACNE TREATMENT FOR THE TREATMENT OF ACNE VULGARIS
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The mean number of Inflammatory Lesions on the face at the beginning and end of treatment
研究概览
简要总结
The purpose of this study is to evaluate a novel, combination product for the treatment of acne vulgaris in females
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 (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 60 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy females 13 years of age or older
- •Non-pregnant, non-lactating females
- •Signed written informed consent form
- •Must be able to understand and be willing to follow all study instructions
- •Have a clinical diagnosis of acne vulgaris
排除标准
- •Female subjects who are pregnant or nursing
- •Any concomitant dermatologic condition that may affect outcome measures
- •Concurrent use of any other medication to treat acne vulgaris
- •Have a history or clinical evidence of any other active acute or chronic medical disease or condition considered by the principal investigator as unsuitable for the study
- •Are currently using any other investigational agent or device
- •Have participated in any other clinical study within 90 days prior to enrollment
- •Employees or family members of sponsor or research site
研究组 & 干预措施
Oral antibiotic plus soy extract
Active Comparator
干预措施: Doxycycline and S-equol (Drug)
Oral antibiotic
Active Comparator
干预措施: Doxycycline (Drug)
结局指标
主要结局
The mean number of Inflammatory Lesions on the face at the beginning and end of treatment
时间窗: 12 weeks
The number of inflammatory lesions will be counted by a trained investigator at the beginning and end of treatment.
次要结局
- The mean number of Comedones will be evaluated at the beginning and end of treatment(12 weeks)
研究者
研究点 (2)
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