Double-blinded, Randomized, Active Control, Single Center-designed, Phase I Clinical Trial to Evaluate the Safety and Efficacy for Improvement of Glabellar Lines of "HG-102" Compared to Botox® in Subjects With Moderate to Severe Glabellar Lines
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Adverse event and adverse drug reaction incidence rates
研究概览
简要总结
To compare the safety and efficacy of "HG-102" with Botox® in the improvement of moderate to severe glabellar lines.
详细描述
Double-blinded, Randomized, Active control, Single center-designed, Phase I clinical trial to evaluate the safety and efficacy for improvement of Glabellar Lines of "HG-102" compared to Botox® in subjects with moderate to severe Glabellar Lines
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
- 否
入选标准
- •Men and women aged between 19 and 65 at screening visit.
- •Patients who voluntarily sign the informed consent.
- •Patients who can comply with the study procedures and visit schedule.
排除标准
- •Patients with infection, skin disorders, or scars at the glabellar region.
- •Patients with facial palsy or the symptoms of blepharoptosis.
- •Fertile women and men who have plans to conceive during pregnancy, breastfeeding and clinical trials or who do not agree to appropriate contraception.
- •Subjects who are not eligible for this study based on investigator's judgement.
研究组 & 干预措施
Botulinum toxin type A(Botox®)
Botulinum toxin type A(Botox®) 100 Unit
干预措施: Botulinum Toxin Type A Injection [Botox] (Drug)
Botulinum toxin type A(HG-102)
Botulinum toxin type A(HG-102) 100 Unit
干预措施: Botulinum toxin type A injection [HG-102] (Drug)
结局指标
主要结局
Adverse event and adverse drug reaction incidence rates
时间窗: Baseline to week 16
Clinically-relevant changes in vital signs, physical exam, and laboratory testing assessed by medical personnel
时间窗: 16 weeks (during the clinical trial)
次要结局
- Responder rate of improvement in glabellar lines with Physician's rating line severity(Baseline to week 4, 8, 12, 16)
- Responder rate of improvement in glabellar lines with investigator's photo assessment(Baseline to week 4, 8, 12, 16)
- Responder rate of improvement in glabellar lines with Subject's improvement assessment(Baseline to week 4, 8, 12, 16)
- Changes in grade by physician's rating line severity for glabellar lines(Baseline to week 4, 8, 12, 16)
- Subject's satisfaction rate(Baseline to week 4, 8, 12, 16)
- The severity of pain evaluated by the subject's Simple Descriptive Scale (SDS)(Baseline)