NCT03970876已完成1 期
A Single Center, Randomized, Double-Blind, Active-controlled, Single-Dose, Phase I/II, Non-Inferiority Study Comparing ATGC-100 and Botox for the Treatment of Moderate to Severe Glabellar Lines in Adult Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE Version 5.0 (Phase I)
研究概览
简要总结
Phase I/II clinical trial will be integrated and conducted. In phase I clinical trial, subjects with moderate to severe glabellar lines at maximum frown are enrolled and safety is assessed after 12 weeks of administration of 20U of ATGC-100. In phase II clinical trial, subjects with moderate to severe glabellar lines at maximum frown are enrolled, and efficacy and safety are assessed by comparing with Botox (Allergan).
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
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females aged between 19 to 65 years old
- •Subjects attaining ≥ grade 2 in the investigator's rating of the severity of glabellar line at maximum frown
- •Subjects who voluntarily signed the informed consent
排除标准
- •Subjects with general neuromuscular synaptic disorders
- •Presence or history of eyelid and/or ptosis
- •Subjects with noticeable facial asymmetry
- •Inability to substantially lessen glabellar frown lines even by physically spreading apart
- •Subjects who have administered the following drugs within 4 weeks prior to screening: Muscle relaxants, Anti-cholinergic agents, Benzodiazepine and similar drugs, Benzamide drugs, Tetracycline antibiotics, Lincomycin antibiotics, Aminoglycoside antibiotics
- •Subjects who are taking Anti-Coagulant and Anti-Platelet agent
- •Subjects who have taken Aspirin and NSAIDs within 7 days prior to administration of investigational drug
- •Subjects with skin disorders at the injection site
- •Subjects with previous treatment of Face Lifting, Permanent Implant, and/or Filler in glabellar region
- •Subjects with prior filler treatments which would have interfered with the evaluation of the efficacy of the study treatment
- •Any other planned facial aesthetic procedure in the glabellar area during the trial period
- •Previous treatment with botulinum toxin in the forehead within the last 5 months or any planned treatment during the study period
- •A history of drug or alcohol abuse
- •Condition including anxiety disorder, or any other significant psychiatric disorder (e.g. depression), in the investigator's opinion
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE Version 5.0 (Phase I)
时间窗: Up tp 12 weeks
Glabellar line improvement rate at maximum frown confirmed with investigator's assessment (Phase II)
时间窗: 4 weeks after the injection
次要结局
- Glabellar line improvement rate at rest confirmed with subject's assessment (Phase II)(4, 8, 12 weeks after the injection)
- Glabella line improvement rate at maximum frown confirmed with investigator's assessment (Phase II)(8, 12 weeks after the injection)
- Glabellar line improvement rate at rest confirmed with investigator's assessment (Phase II)(4, 8, 12 weeks after the injection)
- Number of participants with treatment-related adverse events as assessed by CTCAE Version 5.0 (Phase II)(Up tp 12 weeks)
研究者
研究点 (1)
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