NCT04985916已完成2 期
Clinical Trial to Evaluate ET-01 in Subjects With Lateral Canthal Lines
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- IGA (Investigators Global Assessment)
研究概览
简要总结
This study tests an investigational drug formulation called ET-01, botulinum toxin, Type A, topical, in lateral canthal lines (LCL).
详细描述
This product is being tested for its ability to reduce lateral canthal lines (LCL), also known as Crow's Feet.
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, Investigator)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •able to understand and give written informed consent
- •25 - 65 years of age
- •willing to have facial pictures/videos taken per protocol
- •mild or less Crow's Feet wrinkles (IGA 0-2) "at rest"
- •moderate to severe Crow's Feet (IGA 3-4) "on contraction"
- •ability to correctly grade a series of Crow's Feet pictures
- •moderate to severe Crow's Feet (SSA 3-4) "on contraction"
- •have adequate vision without the use of eyeglasses to assess facial wrinkles in a mirror (contact lenses are OK)
- •willingness to refrain from the use of facial fillers, retinoids, botulinum toxins, 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 childbearing potential must have a negative urine pregnancy test and be non-lactating at the Baseline visit
- •female subjects of childbearing potential must utilize one of the following methods of birth control throughout the study: intra-uterine device (IUD), diaphragm, a condom, a spermicidal gel or foam, oral contraceptives (provided subject has been utilizing this method for at least 3 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) or are in menopause.
- •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
- •history of adverse reactions to any prior botulinum toxin treatments
- •history of vaccination with botulinum toxin
- •history of non-response to any prior botulinum toxin treatments
- •any botulinum toxin treatment anywhere in the prior 6 months
- •history of participation in ET-01-LCL-210 in previous Cohorts 1 or 2 at any time in the past
- •history of periocular surgery, brow lift or related procedures
- •soft tissue augmentation or any procedures affecting the lateral canthal region in the prior 12 months
- •dermabrasion or laser treatment in the periocular region in the last 6 months
- •topical prescription-strength retinoids in the prior 3 months to the treatment area
- •application of any topical prescription medication to the treatment area within 14 days prior to treatment
- •subjects on clinically significant, concomitant drug therapy (See Section 5.3 below).).
- •present or history of neuromuscular disease, eyelid ptosis, muscle weakness or paralysis
- •present or history of "dry eye"
- •hemophilia, hemorrhagic disorder, hemostatic dysfunction or other blood clotting disorders
- •use of systemic aminoglycosides in the week prior to treatment application
- •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
Placebo Comparator
Vehicle, topical liniment, administered once at baseline
干预措施: Vehicle (Biological)
ET-01, Dose 1
Experimental
Dose 1 of botulinum toxin, Type A, topical liniment, administered once at baseline. 250µm microneedle length
干预措施: botulinum toxin, Type A (Biological)
ET-01, Dose 2
Experimental
Dose 2 of botulinum toxin, Type A, topical liniment, administered once at baseline. 250µm microneedle length
干预措施: botulinum toxin, Type A (Biological)
结局指标
主要结局
IGA (Investigators Global Assessment)
时间窗: Week 4
Investigators Global Assessment. Crow's Feet Wrinkle Scale where severity is scored between 0-4 (0=absent; 4=severe).
次要结局
- IGA (Investigators Global Assessment)(Week 2, 4, 8,12, and 18)
- SSA (Subject Self-Assessment)(Week 2, 4, 8,12, and 18)
研究者
研究点 (1)
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