NCT05195112已完成3 期
A Randomized, Double-blind, Placebo-controlled, Multi-center, Phase III Study to Evaluate the Efficacy and Safety of MT921 in Subjects With Moderate to Severe Submental Fat
Medy-Tox1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2021年12月24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
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Proportion of subjects whose CA-SMFRS (Clinician-Assessed Submental Fat Rating Scale) score changed
研究概览
简要总结
The purpose of this study is to evaluate the Efficacy and Safety of MT921 in Subjects with Moderate to Severe Submental fat compared with Placebo.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 19~65 years of age
- •CA-SMFRS and PA-SMFRS score of 2 or 3
- •Satisfaction level is 3points or less
- •Voluntarily provide informed consent
排除标准
- •Following history that can affect the efficacy and safety evaluation in the chin or neck area as judged by the investigator
- •Scars or skin lesion on the study treatment region
- •Liposuction or lipolytic material treatment to decrease submental fat
- •Permanent filler, synthetic implantation and autologous fat grafting
- •Within 1 year of screening visit, semi-permanent filler (Calcium Hydroxyapatite, collagen-stimulator, etc.), radio-frequency treatment, HIFU, thread, laser procedure and chemical peeling procedure over medium-depth
- •Within 6 months of screening visit, temporary filler (Hyaluronic acid, etc.) procedure on the chin or neck, injection of botulinum toxin, radio-frequency treatment, HIFU, thread, laser procedure and chemical peeling procedure over medium-depth
- •BMI over 35.0 kg/m^2
- •Submandibular enlargement due to causes other than localized subcutaneous fat (hyperthyroidism, cervical lymphadenopathy, etc.)
- •Current or past dysphagia
- •Judged difficult to measure submandibular fat due to sagging skin on the chin and neck or wide platysmal bands on the neck
- •Bleeding or taking anticoagulant drugs (except for patients taking anticoagulant drugs, those who can discontinue administration from 3 days before injection to 24 hours after injection of the IP)
- •Skin disease or would infection on the study treatment region
- •Hypersensitivity to Lidocaine, Benzocaine, Procaine or the IP
- •Pregnancy or breast feeding or female of child-bearing potential who has not agreed to use of medically acceptable contraception during the study period
- •All women of childbearing age have negative pregnancy test results can be enrolled in parallel with surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or menopause (amenorrhea for more than 12 months).
- •Medically acceptable contraception: Intrauterine device, Intrauterine system, vasectomy, tubal ligation, condom, Cervical cap, Contraceptive diaphragm, contraceptive sponges, spermicide, oral contraceptive pill and etc.
- •Experience of other clinical trials within 30 days before screening
- •Any other clinically meaningful conditions that are considered ineligible for the study in the medical judgement of principal investigator or sub-investigator
研究组 & 干预措施
MT921
Experimental
- Injection volume/interval: 0.2mL/1.0cm
- Number of Injection: Maximum 50 times
- Concentration per unit area: 3mg/cm2
干预措施: MT921 (Drug)
Placebo
Placebo Comparator
- Injection volume/interval: 0.2mL/1.0cm
- Number of Injection: Maximum 50 times
- Concentration per unit area: 0mg/cm2
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of subjects whose CA-SMFRS (Clinician-Assessed Submental Fat Rating Scale) score changed
时间窗: 12 weeks
Proportion of subjects whose CA-SMFRS decreased 1, 2 points or more compared the 12 weeks after the last administration day to before administration of the IP, Minimum value: 0 (best outcome) / Maximum value: 4 (worst outcome)
Proportion of subjects whose PA-SMFIS (Patient Assessed-Submental Fat Impact Scale) score changed
时间窗: 12 weeks
Proportion of subjects whose PA-MFRS decreased 1, 2 points or more compared the 12 weeks after the last administration day to before administration of the IP , Minimum value: 0 (worst outcome) / Maximum value: 10 (best outcome)
次要结局
- Measuring submental fat volume by MRI (magnetic resonance imaging)(12 weeks)
- Proportion of subjects whose PA-SMFIS (Patient Assessed-Submental Fat Impact Scale) score changed(4 weeks)
- PA-SMFIS (Patient Assessed-Submental Fat Impact Scale)(4 and 12 weeks)
- Satisfaction Evaluation by the subject(4 and 12 weeks)
- Proportion of subjects whose CA-SMFRS (Clinician-Assessed Submental Fat Rating Scale) score changed(4 weeks)
研究者
研究点 (1)
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