NCT05964257招募中3 期
A Double-blind, Randomized, Placebo-controlled, Multi-center, Phase III Study to Evaluate the Efficacy and Safety of LIZTOX in Subjects With Benign Masseteric Hypertrophy.
Huons Biopharma1 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2023年7月25日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Average change from baseline in masseter muscle thickness on both sides at maximum clenching
研究概览
简要总结
A double-blind, randomized, placebo-controlled, multi-center, phase III study to evaluate the efficacy and safety of LIZTOX in subjects with benign massesric hypertrophy
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subject over 19 years of age and written informed consent is obtained.
- •Subject who has bisymmetry of masseter at visual and palpable assessment.
- •Subject who meets thickness of masseter muscle by ultrasonography.
- •Subject who has a scale of benign masseter hypertrophy of 4 or more as determined by investigator.
- •Subject who fully understands this clinical trial and voluntarily writes ICF in the clinical trial.
排除标准
- •Subject who had previously received botulinum toxin within 12 weeks prior to the study entry.
- •Subject who got any facial aesthetic procedure (e.g. surgery, laser, thread treatment etc.) in lower facial area within 48 weeks prior to the study entry.
- •Subject who has a disease(e.g. Temporo mandibular joint disorder, etc.)
- •Subject who were diagnosed Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might influence with neuromuscular function.
- •Subject who had taken medication(e.g. muscle relaxant, polypeptide antibiotics, aminoglycoside antibiotics, etc.) within 4 weeks prior to the study entry.
- •Subject with known hypersensitivity to botulinum toxin.
- •Subject who are pregnant or lactating or planing pregnancy or disagreed to avoid pregnancy during study period.
- •Subject who participate other clinical trials within 4 weeks prior to the study entry.
- •Subject who are not eligible for this study at the discretion of the investigator.
研究组 & 干预措施
HU-014
Experimental
干预措施: Botulinum toxin type A (Drug)
Placebo
Placebo Comparator
干预措施: normal Saline (Drug)
结局指标
主要结局
Average change from baseline in masseter muscle thickness on both sides at maximum clenching
时间窗: 12weeks
The thickness of the masseter muscle is measured using ultrasonography, and the average value is obtained from three measurements.
次要结局
- Average change from baseline in masseter muscle thickness on both sides at maximum clenching(4, 8, 16, 20, 24weeks)
- Average change from baseline in masseter muscle thickness on both sides at rest(4, 8, 12, 16, 20, 24weeks)
- Average rate change from baseline in masseter muscle thickness on both sides at maximum clenching(4, 8, 12, 16, 20, 24weeks)
- Average rate change from baseline in masseter muscle thickness on both sides at rest(4, 8, 12, 16, 20, 24weeks)
- Change from baseline in the lower facial volume at maximum clenching and at rest using Morpheus 3D imaging(4, 8, 12, 16, 20, 24weeks)
- Rate of change from baseline in the lower facial volume at maximum clenching and at rest using Morpheus 3D imaging(4, 8, 12, 16, 20, 24weeks)
- The proportion of subjects who reported an overall improvement of more than 50% at maximum clenching and at rest.(4, 8, 12, 16, 20, 24weeks)
- The proportion of subjects who rated overall satisfaction as 'satisfied' at maximum clenching and at rest(4, 8, 12, 16, 20, 24weeks)
- The proportion of subjects with a masseter muscle hypertrophy scale (MMHS) ≤3(4, 8, 12, 16, 20, 24weeks)
研究者
研究点 (1)
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