NCT06246552已完成2 期
Multicenter, Randomized, Double-blind, Placebo-controlled, Single-dose Phase 2 Study of the Safety and Efficacy of JTM201 (Botulinum Toxin Type A) to Treat Moderate or Severe Glabellar 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
- 480
- 试验地点
- 1
- 主要终点
- SAE
研究概览
简要总结
This is Multicenter, Randomized, Double-blind, Placebo-controlled, Single-dose Study to evaluate Safety and Efficacy of JTM201 in patients with Moderate or Severe Glabellar Lines
详细描述
This is Multicenter, Randomized, Double-blind, Placebo-controlled, Single-dose Study to evaluate Safety and Efficacy of JTM201 in patients with Moderate or Severe Glabellar Lines. Treatment period is 180 days and evaluation of the safety is the primary endpoint
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects ≥18 years of age based on the date of the written informed consent form.
- •Subject is able to provide written informed consent and comply with study procedures.
- •Subject has moderate or severe glabellar lines on maximum frown as assessed by the investigator and subject using the GLS (score of 2 or 3).
排除标准
- •Previous insertion of permanent material in the glabellar area including the forehead.
- •Planned treatment with botulinum toxin of any serotype in any other body region during the study period.
- •Pregnant or breastfeeding (directly or via pump); or planning to become pregnant during the study.
- •Known allergy or hypersensitivity to botulinum toxin or product excipients.
- •Participation in another interventional clinical study ≤30 days of Visit 1: Screening.
- •Planning to donate, bank, or retrieve eggs (ova, oocytes) or donate sperm during the study.
研究组 & 干预措施
JTM201
Experimental
Botulinum toxin
干预措施: JTM201 (Biological)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Biological)
结局指标
主要结局
SAE
时间窗: 180 days
Serious AEs (SAEs) from the screening period through end of follow-up
TEAE
时间窗: 180 days
Treatment-emergent AEs (TEAEs) from Baseline through end of followup
次要结局
未报告次要终点
研究者
研究点 (1)
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