NCT00978887已完成3 期
Efficacy of Retorna Facial Cream Usage in the Treatment of Facial Wrinkles
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Catalysis SL
- 入组人数
- 148
- 试验地点
- 2
- 主要终点
- Total correction or improvement of facial wrinkles at the end of treatment (4 weeks)
研究概览
简要总结
The purpose of the study is to assess the efficacy of Retorna facial cream usage in the reduction or total correction of facial wrinkles. The duration of this double-blind placebo controlled phase 3 clinical trial will be 4 weeks. The estimated number of women to be recruited and randomized for the study is 148. Occurrence of adverse effects will also be evaluated.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Facial wrinkles
- •Signed informed consent
- •Given verbal agreement on solar exposure prevention within hours of intense solar radiation (10 am - 4 pm) by the usage of physical protection methods such as umbrellas, caps and hats.
排除标准
- •Pregnancy
- •Breast-feeding
- •Use of steroids within 6 months.
- •Patients under other experimental treatment
- •Decompensated concomitant diseases
- •Malignant neoplastic conditions.
- •Alcoholism
- •Handicap and/or psychiatric condition preventing treatment accomplishment.
结局指标
主要结局
Total correction or improvement of facial wrinkles at the end of treatment (4 weeks)
时间窗: 4 weeks
次要结局
- Presence of adverse effects within the 4 week treatment period(4 weeks)
研究者
研究点 (2)
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