A Randomized, Evaluator-blinded, Comparative Study to Evaluate the Efficacy and Safety of Different Injection Volumes of Botulinum Toxin Type A, Azzalure, in the Glabellar Lines
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Assessment of severity of glabellar lines at rest and at maximum frown using the Merz Aesthetic 5-point scale. (However no primary outcome measure is defined in the study protocol)
研究概览
简要总结
A randomized, evaluator-blinded, comparative, study to evaluate the efficacy and safety of different injection volumes of botulinum toxin type A, Azzalure, in the glabellar lines.
详细描述
Clarification regarding injection volumes for the different study groups:
Subjects will be randomized to Group A or Group B (1:1).
- Group A: 0,63ml NaCl will be used to reconstitute toxin in the vial. 0,05mL will be injected (equal to a dose of 10s.U.)
- Group B: 1,25ml NaCl will be used to reconstitute toxin in the vial. 0,1 mL will be injected (equal to a dose of 10s.U.).
The two different reconstitution volumes (each containing a dose of 10s.U. botulinum toxin A) will be compared as described under objectives.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women, 18 to 64 years of age
- •Subjects seeking treatment for moderate to severe glabellar lines when the severity of these lines has an important psychological impact on the subject, as determined by the investigator.
排除标准
- •Subjects previously treated with any botulinum toxin product.
- •Pregnant or breast feeding women or women intending to get pregnant in the next 12 months.
- •Subjects with signs and symptoms of eyelid or brow ptosis or signs of compensatory frontalis muscle activity, as judged by the investigator.
- •Subjects with clinical or subclinical neuromuscular junctional disorders (e.g. myasthenia gravis, Lambert Eaton syndrome or amyotrophic lateral sclerosis) or a history of dysphagia or aspiration.
- •Subjects with previous or current diagnosis of Bell's paresis.
- •Subjects with known bleeding disorders or subjects who are taking thrombolytics or anticoagulants.
- •Subjects who are taking anticholinergics or aminoglycoside antibiotics.
- •Any prior surgery in the facial area that, in the opinion of the investigator, may interfere with the results.
- •Subjects treated with fillers, HA filler or permanent filler, in the upper face one year or less from screening.
研究组 & 干预措施
Azzalure 10 Speywood units/injection
Azzalure (botulinum toxin type A), powder for solution for injection, Total dose 50 s.U (5 x 10s.U)
干预措施: Azzalure (Drug)
Azzalure, 10 Speywood units/injection
Azzalure (botulinum toxin type A), powder for solution for injection, Total dose 50 s.U (5 x 10s.U)
干预措施: Azzalure (Drug)
结局指标
主要结局
Assessment of severity of glabellar lines at rest and at maximum frown using the Merz Aesthetic 5-point scale. (However no primary outcome measure is defined in the study protocol)
时间窗: Month 1
To evaluate effect on glabellar line severity
次要结局
未报告次要终点