Botox Cosmetic and the Young Patient With Glabellar Furrows
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Reduction of the Facial Wrinkle Scale
研究概览
简要总结
The purpose of this study is to see if consistent treatment with Botox will lead to longer lasting effects. Botox is an injectable liquid that is approved by the U.S. Food and Drug Administration to reduce wrinkles on the forehead in the area between the eyebrows. In this study a different dosing schedule of Botox injections will be used to see if the effects of the Botox treatment last longer than the effects of the standard injection regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Fitzpatrick Skin Types I-III
- •Between 30 and 50 years of age
- •At least moderate severity at maximum frown
排除标准
- •Prior botulinum toxin treatment
- •Any disorder (such as myasthenia gravis, Eaton-Lambert syndrome) or agent (such as aminoglycoside antibiotics) that might interfere with neuromuscular function
- •Any other condition or situation that might put the subject at significant risk, confound the study results (such as significant pre-existing brow or eyelid ptosis)
- •Allergy or sensitivity to any study component
- •Participation in another clinical study within 30 days of the study start date
- •Are planning other facial cosmetic procedures during the study period, or are pregnant, breastfeeding, or planning a pregnancy during the study.
研究组 & 干预措施
Botox
Botox Cosmetic will be delivered in standard doses of 4 units per injection site over a total of 5 sites, thus treating the procerus and corrugator superciliaris muscle groups
干预措施: Botox (Drug)
结局指标
主要结局
Reduction of the Facial Wrinkle Scale
时间窗: 26 months
Four-point validated facial wrinkle scale (FWS) Minimum score = 0 (no wrinkles) Maximum score = 3 (deep wrinkles) Baseline to 20 months is the active injection phase 20 months to 26 months is the follow-up phase
Patient Assessed Frown-line Improvement
时间窗: 20 months
Four-point satisfaction scale Neutral = 0 (minimum score) Somewhat satisfied = 1 Definitely satisfied = 2 Greatly satisfied = 3 Couldn't be more satisfied = 4 (maximum score) Baseline to 20 months is the active injection phase 20 months to 26 months is the follow-up phase
次要结局
未报告次要终点
研究者
Roger Dailey
Professor
Oregon Health and Science University