A Phase 1/2 Study to Establish An Initial Therapeutic Range and Safety Data for AI-09 in the Treatment of Glabellar Lines
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 5
- 主要终点
- Investigators Global Assessment (IGA)
研究概览
简要总结
AI-09 In Subjects with Glabellar Lines
详细描述
A Phase 1/2, multicenter, out-patient, prospectively randomized, double-blind, vehicle-controlled study to establish an initial therapeutic range for AI-09 in the treatment of glabellar lines and provide initial data regarding its potential safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- 是
入选标准
- •able to understand and give written informed consent
- •willingness to have their pictures taken
- •20 - 70 years of age
- •moderate to severe glabellar lines (IGA 2-3) on contraction
- •moderate to severe glabellar lines (SSA 2-3) on contraction
- •none to mild glabellar lines wrinkles (IGA 0-1) at rest
- •willingness to refrain from the use of facial fillers, retinoids, Botox, laser treatments, or any product affecting skin remodeling or that might cause an active dermal response during the course of the study
- •female subjects of child-bearing potential must have a negative urine pregnancy test and be non-lactating at the Baseline visit
- •female subjects of child-bearing potential must utilize one of the following methods of birth control throughout the study: IUD, diaphragm, a condom, a spermicidal gel or foam, oral contraceptives (provided subject has been utilizing this method for at least 4 months prior to Baseline and has not changed the brand within this period), or patch, injectable, implantable, or vaginal ring contraceptives. Subjects may also participate if they are surgically sterilized (tubal sterilization or hysterectomy)
- •subjects 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
- •excessive weakness or atrophy in the target muscle(s)
- •eyelid ptosis
- •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 a 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
- •subjects on clinically significant, concomitant drug therapy
- •participation in another investigational drug trial or receiving any investigational treatment(s) within 30 days of Baseline
- •alcohol or drug abuse within the past 3 years
- •psychiatric disease interfering with the subject's ability to give informed consent
- •refusal or inability to comply with the requirements of the protocol for any reason
研究组 & 干预措施
Vehicle Dose 5
Vehicle, intramuscular injection, administered once at baseline
干预措施: Vehicle (Biological)
Vehicle Dose 3
Vehicle, intramuscular injection, administered once at baseline
干预措施: Vehicle (Biological)
Vehicle Dose 7
Vehicle, intramuscular injection, administered once at baseline
干预措施: Vehicle (Biological)
AI-09 Dose 6
Dose 6 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline
干预措施: AI-09 (Biological)
AI-09 Dose 1
Dose 1 of botulinum toxin, Type A, intramuscular injection, administered once at baseline
干预措施: AI-09 (Biological)
AI-09 Dose 3
Dose 3 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline
干预措施: AI-09 (Biological)
AI-09 Dose 5
Dose 5 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline
干预措施: AI-09 (Biological)
Vehicle Dose 2
Vehicle, intramuscular injection, administered once at baseline
干预措施: Vehicle (Biological)
Vehicle Dose 1
Vehicle, intramuscular injection, administered once at baseline
干预措施: Vehicle (Biological)
AI-09 Dose 4
Dose 4 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline
干预措施: AI-09 (Biological)
Vehicle Dose 4
Vehicle, intramuscular injection, administered once at baseline
干预措施: Vehicle (Biological)
Vehicle Dose 6
Vehicle, intramuscular injection, administered once at baseline
干预措施: Vehicle (Biological)
AI-09 Dose 2
Dose 2 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline
干预措施: AI-09 (Biological)
AI-09 Dose 7
Dose 7 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline
干预措施: AI-09 (Biological)
结局指标
主要结局
Investigators Global Assessment (IGA)
时间窗: 18 Weeks (26 Weeks for Cohorts 4, 5 & 6)
Investigators Global Assessment. Glabellar Line Severity scale where severity is scored between 0-4 (0=absent; 4=severe).
Percentage of Responders by Dose Group at the Week 4 Visit; R=I+S-C≤1
时间窗: 4 Weeks
Investigator and Subject Assessment (R=I+S-C≤1), percentage of responders achieving a score of 0 (Absent) or 1 (Mild) on the Glabellar Line Severity scale where severity is scored between 0-3 (0=absent; 3=severe).
次要结局
- Total Number of Observations With a Response Defined as Change ≥2 in IGA-C and SSA-C Score(Week 1, 2, 4, 8, 12, 18 (Week 26 assessments for Cohorts 4, 5 & 6))
- % of Responders at Week 4 With Improvement From Baseline On-contraction by at Least 2 Points by Investigator and Subject's Self Assessment (I+S-C CfB≥2), on the Glabellar Line Severity Scale Where Severity is Scored Between 0-3 (0=Absent; 3=Severe).(4 Weeks)