NCT00247559已完成2 期
A Phase II, Multi-Centre, Randomised, Double-blind, Dose-Ranging Study Comparing the Efficacy and Safety of a Single Treatment With 15, 30 or 45 Units (Per Eye) of Dysport to Placebo in the Symptomatic Treatment of Lateral Canthal Lines (Crow's Feet)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 221
- 试验地点
- 18
- 主要终点
- Change in severity of crow's feet at maximum smile at week 4, compared to baseline, assessed photographically by independent panel
研究概览
简要总结
Despite the wealth of information in the literature regarding the cosmetic applications of botulinum type A toxin (BoNT-A), and the widespread use of the BoNT-A for cosmetic applications, the number of randomised, controlled clinical trials is small. Much of the published information is based on open-label studies or anecdotal data. Of the robust trial data that is available, the vast majority relates to the treatment of glabellar lines, and there is little data available regarding the use of BoNT-A in lateral canthal lines. This study aims to determine the optimum dose for the use of BoNT-A in this area.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients, 18 to 65 years of age.
- •In the opinion of the Investigator moderate to severe lateral canthal lines (crow's feet) during maximum smile on both sides of the face.
- •In the opinion of the Investigator mild to severe lateral canthal lines (crow's feet) at rest on both sides of the face.
排除标准
- •Any prior surgery affecting the orbicularis oculi muscle, prior blepharoplasty or brow lift, or any prior cosmetic procedures or scars that may interfere with the evaluation of the study results.
- •Previous insertion of any non-absorbable material in the periorbital region or facial treatment with augmentation material within 12 months prior to screening.
- •Any prior treatment with botulinum toxin (of any serotype).
- •Previous treatment with lasers for skin resurfacing or treatment with deep chemical peels within 12 months prior to screening.
- •Inability to substantially lessen the lateral canthal lines by physically spreading them apart.
- •Facial conditions that could affect safety or efficacy results such as: active infection or other skin problem in the periorbital area (e.g. acute acne lesions or ulcers); history of facial nerve palsy; marked facial asymmetry; ptosis; excessive dermatochalasis; deep dermal scarring; thick sebaceous skin; photodamage etc.
结局指标
主要结局
Change in severity of crow's feet at maximum smile at week 4, compared to baseline, assessed photographically by independent panel
次要结局
- At week 2,4,8,12,16,20,24, compared to baseline: change in severity of crow's feet at rest & max. smile, assessed by investigator & independent panel (photographically); change in patient satisfaction with appearance of crow's feet & general appearance
研究者
研究点 (18)
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