NCT01740934已完成不适用
An Eight-Week, Multi-Site, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Trial to Evaluate the Safety, Tolerability, and Effects of Anatabloc® Crème in Subjects With Rosacea Followed by an Open-Label Extension
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 6
- 主要终点
- Adverse Effects
研究概览
简要总结
This is a multi-site, four-visit, eight-week, double-blind, randomized, vehicle-controlled, parallel-group study followed by an eight-week open-label extension to evaluate the safety, tolerability, and potential effects of Anatabloc Facial Cream. The secondary aim is to evaluate if Anatabloc Facial Cream improves the appearance of the skin in subjects with mild to moderate rosacea.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age between 25-70 years
- •diagnosed with mild to moderate rosacea
排除标准
- •allergy or sensitivity to the study products or their components
- •severe rosacea
- •current use of glucocorticoids, anti-acne products, antibiotics, topical retinoids, or vasoactive drugs
- •recent oral isotretinoin use
- •current use of anatabine-containing supplements (ie. Anatabloc, Anatabloc Unflavored, CigRx)
结局指标
主要结局
Adverse Effects
时间窗: 8 to 16 weeks
Collected information of the safety, tolerability and adverse events, and subjective experience related to the use of Anatabloc Cream by subjects
次要结局
- Change in the appearance of the facial skin(8 to 16 weeks)
研究者
研究点 (6)
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