NCT01308060已完成3 期
A Multi-center Randomized, Double-blind, Placebo Controlled, Parallel-group Study of CD07743 for the Improvement of Lateral Canthal Lines (Crow's Feet)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 335
- 主要终点
- Number of Responders on the Severity of Lateral Canthal Lines "at Maximum Smile".
研究概览
简要总结
This double-blind study has two parts for each subject (same population):
Part A: initial treatment in Lateral Canthal Lines (LCL) (placebo-controlled):
- To assess the efficacy and safety of Azzalure® compared to placebo in the improvement of moderate to severe LCLs.
- To assess the subjects' level of satisfaction with the appearance of their LCLs compared to placebo.
Part B: repeated treatment in LCL with or without Glabellar Lines (GL) (active treatment, up to 1 year):
- To assess safety of Azzalure® following repeated administration in the improvement of moderate to severe LCLs.
- To assess the safety of Azzalure® when used concomitantly for improvement of moderate to severe LCLs and GLs.
- To assess the subjects' level of satisfaction with the appearance of their LCLs.
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 (Participant, Investigator)
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 subjects, 18 to 65 years of age (Screening visit),
- •Moderate or severe (grade 2 or 3, Hund 2006) Lateral Canthal Lines "at maximum smile" determined by investigator at screening and baseline
- •Mild to severe (grade 1, 2 or 3, Hund 2006) Lateral Canthal Lines "at rest" determined by investigator at screening and baseline
- •The subject is a female of childbearing potential and has a negative urine pregnancy test (UPT) at screening and baseline
- •Subjects who are not satisfied with their appearance at screening and baseline
- •The subject is willing and able to comply with the requirements of the protocol and agree to adhere to the visit schedule, concomitant therapy prohibitions and must be compliant to the study instruction.
- •The subject agrees to participate in the study, verified by dating and signing an approved written Informed Consent Form (ICF) and Photography Consent Form (PCF) (selected sites only if applicable) at the enrolment visit before any study procedures at screening
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 investigator.
- •Previous insertion of any permanent, semi-permanent or biodegradable material in the periorbital region or facial treatment with augmentation material (e.g. silicon injections, collagen type implants, hyaluronic acid, lactic acid, etc.) within 12 months prior to screening.
- •Any prior treatment with botulinum toxin (of any serotype)
- •Previous treatment with lasers for skin resurfacing (e.g. CO2 (carbon dioxide)-laser) or treatment with deep chemical peels and any other esthetic or dermatologic treatments or procedures in any area of the face within 12 months prior to screening.
- •Any planned facial cosmetic surgery or procedures during the study period.
- •Presence of any bleeding disorders
- •Pregnant or lactating women or women who are planning pregnancy during the study.
- •Known hypersensitivity to any of the test materials or related compounds.
研究组 & 干预措施
Botulinum Toxin type A
Experimental
During part A, efficacy and safety parameters will be assessed for Azzalure vs. placebo
干预措施: Botulinum Toxin Type A (Drug)
Placebo
Placebo Comparator
During part A, efficacy and safety parameters will be assessed for Azzalure vs. placebo
干预措施: Placebo (Other)
结局指标
主要结局
Number of Responders on the Severity of Lateral Canthal Lines "at Maximum Smile".
时间窗: Week 4
A positive response (responder) is defined as a grade of 0 or 1 (none or mild), as assessed by the investigator.
次要结局
- Number of Participants Satisfied With the Appearance of Their Lateral Canthal Lines(Week 4)
研究者
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