A Single-arm Trial, Open-label, Repeated, Long-term, Multi-center, Phase IV Clinical Trial to Evaluate the Long-term Efficacy and Safety of Repeat Treatment of Glabellar Lines With CORETOX®
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Investigator-rated improvement rate of glabellar lines at maximum frown at Week 4 of each treatment cycle
研究概览
简要总结
This study evaluates the long-term safety and efficacy of CORETOX in the treatment of moderate to severe glabellar lines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged between 20 and 65
- •Patients attaining ≥grade 2 (moderate) in the investigator's rating of the severity of glabella lines at maximum frown
- •Patients who can comply with the study procedures and visit schedule
- •Patients who voluntarily sign the informed consent
排除标准
- •Patients with medical conditions who may be at greater risk due to the administration of the investigational drugs (e.g.. diseases that may affect the neuromuscular action including Myasthenia Gravis, Lambert-Eaton Syndrome, Amyotrophic Lateral Sclerosis and motor neuropathy)
- •Patients with the history of facial nerve paralysis or the symptoms of eyelid ptosis
- •Patients who have received other procedures which may affect glabellar and forehead lines within 6 months
- •Patients who have received other procedures which may affect glabellar and forehead lines within 6 months
- •Patients who were injected with botulinum toxin within the past 3 months
- •Patients with allergy or hypersensitivity to the investigational drugs or their components
- •Patients who have bleeding tendency or taking anti-coagulant
- •Female subjects who are pregnant or lactating. Female subjects of childbearing age who have a plan to get pregnant during the study period, or do not use available contraceptive methods (Women of childbearing age should have negative urine pregnancy test results at baseline visit (0 week) prior to the first injection.)
- •Patients with skin disorders or infection at the injection site
- •Patients who are participating in other clinical trials or have participated in other clinical trials 30 days before screening
- •Patients who are unable to communicate or follow the instructions
- •Patients who are not eligible for this study based on the judgment of an investigator
结局指标
主要结局
Investigator-rated improvement rate of glabellar lines at maximum frown at Week 4 of each treatment cycle
时间窗: At Week 4 of each cycle (each cycle lasts until re-treatment, where re-treatment is possible after 90 Days from the last treatment).
Improvement rate: improvement of Facial Wrinkle Scale score from 3 (moderate) or 4 (severe) to 0 (none) or 1 (mild)
Subject-rated improvement rate of glabellar lines at maximum frown
时间窗: Every 4 weeks in each treatment cycle (each cycle lasts until re-treatment, where re-treatment is possible after 90 Days from the last treatment).
Subject-rated satisfaction at each cycle after treatment
时间窗: Every 4 weeks in each treatment cycle (each cycle lasts until re-treatment, where re-treatment is possible after 90 Days from the last treatment).
Treatment on-set date
时间窗: From baseline to Day 7 of each cycle (each cycle lasts until re-treatment, where re-treatment is possible after 90 Days from the last treatment).
Treatment duration
时间窗: From on-set date to next treatment (each cycle lasts until re-treatment, where re-treatment is possible after 90 Days from the last treatment).
Number of participants who experienced an adverse event
时间窗: Baseline to Day 720
Number of participants with binding and neutralizing antibodies
时间窗: Screening and Day 720
次要结局
未报告次要终点