NCT00434863已完成4 期
A Comparative Randomized Double-Blinded Study of the Effect of Dysport and Botox on Forehead Wrinkles and EMG Activity
Laserklinik Karlsruhe2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2005年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- EMG Muscular Activity at baseline and 0.5, 1, 2, 4, 8 and 10 weeks after injection, followed by weekly examinations for a total observation period of 20 weeks
研究概览
简要总结
The purpose of this study is to test the effect of Dysport and Botox on forehead wrinkles and EMG activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age between 30 and 70 years
- •moderate to severe hyperfunctional forehead wrinkles at maximum contraction and at rest
排除标准
- •application of botulinum toxin products for a period of 12 months prior to the study
- •any significant health disturbances
- •facial nerve palsy, and any facial conditions that could confound safety or efficacy results
- •pregnancy and breast-feeding
- •neuromuscular diseases
- •drugs interfering with neuromuscular function (e.g. aminoglycosides)
结局指标
主要结局
EMG Muscular Activity at baseline and 0.5, 1, 2, 4, 8 and 10 weeks after injection, followed by weekly examinations for a total observation period of 20 weeks
Frown Wrinkle Severity (photographs and questionnaire) at baseline and 0.5, 1, 2, 4, 8 and 10 weeks after injection, followed by weekly examinations for a total observation period of 20 weeks
次要结局
- Side Effects upon completion of the study (20 weeks after injection)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Study to Compare 2 Botulinum Type A Toxins in the Treatment of Glabellar Frown LinesFrown LinesNCT04763265Croma-Pharma GmbH208
已完成
4 期
Onabotulinum Toxin Type A and Abobotulinum Toxin Type A Crow's Feet Rhytid StudyIntrinsic Aging of SkinSolar ElastosisNCT01529788The Maas Clinic90
进行中（未招募）
早期 1 期
Split-Face Study Comparing Botox and Jeuveau in Treating Glabellar LinesGlabellar Frown LinesNCT04715048University of Southern California20
已完成
2 期
Safety and Efficacy Study of Botox in the Treatment of Forward Head Posture With Associated Episodic Headache DisorderForward Head Posture With Associated Episodic Headache DisorderNCT01350375The Research Center of Southern California30
已完成
不适用
BOTOX® Cosmetic and Skin Health.Oily SkinNCT05138835Andreas Nikolis34