Phase II Multi-Ctr, Prospective, Randomized, Double Blind, Active-Controlled Single Treatment Increasing Dose Trial to Study Safety & Duration of Effect of 40U of PrabotulinumtoxinA-xvfs in Adult Subjects for Treatment of Glabellar Lines
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Evolus, Inc.
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- Duration of Effect Described by Kaplan-Meier Analysis
研究概览
简要总结
The purpose of this study is to demonstrate the safety and duration of effect of 40 Units of prabotulinumtoxinA-xvfs (Jeuveau®) in providing temporary improvement in the appearance of moderate to severe glabellar lines (frown lines, which are the vertical lines that develop between the eyebrows) in adult participants. It will also determine if the duration of effect of 40 Units of Jeuveau® is greater than that of 20 Units of Jeuveau® and 20 Units of Botox® Cosmetic.
详细描述
This is a multicenter, prospective, randomized, double-blind, active-controlled, single-treatment, increasing dose design. Up to one hundred and fifty subjects will be randomized 1:1:1, to either 20 Units onabotulinumtoxinA (Botox® Cosmetic), 20 Units prabotulinumtoxinA-xvfs (Jeuveau®), or 40 Units prabotulinumtoxinA-xvfs (Jeuveau®).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Outpatient, male or female of any race, 18 years of age or older.
- •Female subjects of childbearing potential must have a negative UPT during Visits 1 (Screening) and 2 and practice a reliable method of contraception for the duration of the study.
- •Moderate to severe glabellar lines (i.e., score of 2 or 3) on maximum frown as assessed by the investigator using the GLS.
- •Subject has moderate to severe glabellar lines (i.e., score of 2 or 3) at maximum frown as assessed by the subject using the GLS.
- •Able to follow study instructions and likely to complete all required visits.
- •Sign the IRB-approved ICF prior to any study-related procedures being performed.
排除标准
- •Female subjects who are pregnant, breast-feeding, or of childbearing potential and not practicing reliable birth control.
- •Known hypersensitivity or previous allergic reaction to any constituent of the IP or control.
- •Any active infection in the area of the injection sites.
- •Inability to substantially lessen glabellar frown lines even by physically spreading them apart.
- •Marked facial asymmetry (Investigator discretion).
- •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 (Investigator discretion).
- •Medical condition that may affect neuromuscular function (e.g., myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis).
- •Previous treatment with botulinum toxin of any serotype above the level of the lateral canthus within the last 6 months.
- •Planned treatment with botulinum toxin of any serotype below the level of the lateral canthus during the study period.
- •Previous treatment with any facial aesthetic procedure (e.g., injection with biodegradable fillers, chemical peeling, photo rejuvenation) in the glabellar area within the last 12 months.
- •Previous insertion of permanent material in the glabellar area.
- •Any previous energy based or cryotherapy-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 (can continue with their usual skin care routine).
- •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 eyebrow).
- •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.
- •Evidence of recent alcohol or drug abuse (Investigator discretion).
- •History of poor cooperation or unreliability.
- •Planning to move out of the area prior to study completion.
- •Subjects who are investigational site staff members or family members of such employees.
- •Exposure to any other investigational drug/device within 30 days prior to Visit 1.
研究组 & 干预措施
Study Drug
40U of PrabotulinumtoxinA-xvfs
干预措施: PrabotulinumtoxinA-Xvfs (Drug)
OnabotulinumtoxinA
20U of OnabotulinumtoxinA
干预措施: OnabotulinumtoxinA (Drug)
PrabotulinumtoxinA-xvfs
20U of PrabotulinumtoxinA-xvfs
干预措施: PrabotulinumtoxinA-Xvfs (Drug)
结局指标
主要结局
Duration of Effect Described by Kaplan-Meier Analysis
时间窗: Duration of effect for each subject will be based on number of days from baseline to the day that Glabellar Line Scale severity (Investigator Assessment) returns to baseline value, assessed every 30 days up to 365 days.
Effectiveness of prabotulinumtoxinA 40 Units compared to prabotulinumtoxinA 20 Units will be assessed for each subject based on the number of days from baseline to the day that the Glabellar Line Scale (GLS) severity, by Investigator Assessment, returns to the baseline value. The treatment will be considered to remain effective for the amount of time during which the GLS severity at maximum frown has not returned to baseline severity.
次要结局
未报告次要终点