A Phase 2, Randomized, Double-blind, Vehicle-Controlled, Multi-Center Clinical Trial Study to Evaluate Ready to Use Injectable AI-09 In Participants With Glabellar Lines
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 68
- 试验地点
- 7
- 主要终点
- IGA-C
研究概览
简要总结
Phase 2 clinical study to evaluate the efficacy, safety, and tolerability of AI-09, a Ready-to-Use Liquid Injectable Botulinum Toxin.
详细描述
This is a Phase 2, multicenter, out-patient, prospectively randomized, double-blind, vehicle-controlled, multi-center clinical study to evaluate the efficacy, safety, and tolerability of AI-09, a Ready-to-Use Liquid Injectable Botulinum Toxin, administered to participants with glabellar lines. The study is designed as a single dose study evaluating AI-09 at a dose of versus Vehicle.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double Blind
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20 to 70 years of age
- •moderate to severe glabellar lines (IGA 2 to 3) at maximum frown
- •moderate to severe glabellar lines (SSA 2 to 3) at maximum frown
- •willingness to refrain from the use of facial fillers, retinoids, Botox®, laser
- •female participants of child-bearing potential must have a negative urine pregnancy test and be non-lactating at the Baseline (Day 0) visit and must utilize birth control throughout the study
- •participants should be in good general health as determined by the investigator and free of any disease that may interfere with study evaluations or the Investigational Product
排除标准
- •the inability to substantially lessen glabellar lines by physically spreading them apart
- •eyelid ptosis, and/ or excessive weakness or atrophy in the target muscle(s)
- •presence or history of "dry eye"
- •history of periocular surgery, brow lift or related procedures, or deep dermal scarring
- •concurrent or recent (within the last 6 months) use of any other botulinum toxin drug product anywhere in the body
- •history of immunization or hypersensitivity to any botulinum toxin serotype
- •history of non-response to any prior botulinum toxin treatments anticipated need for treatment with botulinum toxin of any serotype for any reason during the trial (other than the investigational treatment)
- •any medical condition that may put the subject at increased risk with exposure to botulinum toxin including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
- •pregnancy or lactation
- •application of any topical prescription medication to the treatment area within 14 days prior to treatment
- •participation in another investigational drug trial or receiving any investigational treatment(s) within 30 days of Baseline (Day 0)
- •alcohol or drug abuse within the past 3 years
- •refusal or inability with the subject's ability to give informed consent or comply with the requirements of the protocol for any reason
研究组 & 干预措施
Active Treatment
AI-09
干预措施: AI-09 Ready Use Injectable Botulinum Toxin (Biological)
Vehicle
Vehicle
干预措施: Vehicle (Biological)
结局指标
主要结局
IGA-C
时间窗: From enrollment (baseline) to the Week 04 Visit
Change from Baseline (CfB) in IGA-C (Investigator Global Assessment on Contraction) as assessed using the 4-point Glabellar Line Severity Scale (GLS), with score "3" being Severe and score "0" being None.
次要结局
未报告次要终点