A Multi-center, Open Label, Multiple Dose, Phase II Trial to Demonstrate the Safety of DWP-450 in Adult Subjects for Treatment of Moderate-to-severe Glabellar Lines.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Evolus, Inc.
- 入组人数
- 352
- 试验地点
- 1
- 主要终点
- The Safety of Repeat DWP-450 Treatments - Proportion of Subjects With at Least One Adverse Event Over 1 Year
研究概览
简要总结
The purpose of this study is to demonstrate the safety of multiple doses of DWP-450 (Botulinum purified neurotoxin, Type A) Injection in treatment of moderate to severe glabellar lines in adult subjects.
详细描述
Three hundred and fifty subjects will be enrolled and injected with the study drug DWP-450 over the course of the 365 day study.
Subjects with moderate or severe glabellar lines at maximum frown on the 4 point Glabellar Line Scale (GLS, 0=none, 1= mild, 2=moderate, 3=severe), as judged by the investigator, will be eligible for injection with DWP-450. After each injection, subjects will be followed and are eligible for a repeat injection if their GLS is ≥2 at maximum frown, as judged by the Investigator. If a subject does not have a GLS≥2 they will be followed monthly until eligible for repeat treatment.
Subjects may receive up to a maximum of 4 treatments and will be followed for 365 days from initial treatment.
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
盲法说明
Open Label
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(A subject must meet all of the following inclusion criteria in order to be eligible for enrollment in the study):
- •Subjects must be an adult 18 years of age or over
- •Subject is able to provide informed consent and comply with study instructions
- •Subject has moderate to severe glabellar lines on maximum frown as assessed by the investigator using the GLS
- •Subject is willing and able to complete the entire course of the study
排除标准
- •(A subject must not meet the following exclusion criteria in order to be eligible for enrollment in the stud)y:
- •Previous treatment with botulinum toxin of any serotype in the forehead area within the last 8 months
- •Previous treatment with any facial aesthetic procedure (e.g. injection with fillers, chemical peeling, photo rejuvenation) in the glabellar area within the last 12 months
- •Previous insertion of permanent material in the glabellar area
- •Planned treatment with botulinum toxin of any serotype in any other body region during the study period
- •Any surgery in the glabellar area including surgical removal of the corrugator, procerus, or depressor supercilii muscles or a combination of these, or scars in the glabellar area and the surrounding areas (including eye brow)
- •Energy based or cryo-therapy based treatment of facial muscles superior to the lateral canthus
- •Any other planned facial aesthetic procedure during the trial period, superior to the level of the lateral canthus (subjects can continue with their usual skin care routine)
- •Inability to substantially lessen glabellar frown lines even by physically spreading them apart
- •Marked facial asymmetry
- •Ptosis of eyelid and/or eyebrow, or history of eyelid and/or eyebrow ptosis
- •History of facial nerve palsy
- •Excessive dermatochalasis, deep dermal scarring, thick sebaceous skin
- •Any active infection in the area of the injection sites
- •Medical condition that may affect neuromuscular function (e.g., myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis)
- •Evidence of recent alcohol or drug abuse
- •Medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study
- •Pregnant or sexually active female subjects who are of childbearing potential and who are not willing to use an acceptable form of contraception
- •Known allergy or hypersensitivity to botulinum toxin preparation
- •Participation in another interventional clinical study within the last 30 days
研究组 & 干预措施
Botulinum neurotoxin, Type A
DWP-450 (Botulinum purified neurotoxin, Type A) Injection
干预措施: Botulinum purified neurotoxin, Type A (Biological)
结局指标
主要结局
The Safety of Repeat DWP-450 Treatments - Proportion of Subjects With at Least One Adverse Event Over 1 Year
时间窗: 365 Days
The primary safety analysis was the calculation of the proportion of subjects with at least one adverse event that occurred from Day 0 through Day 365.
次要结局
未报告次要终点