NCT03946592已完成3 期
A Randomized, Double-blind, Multi-center, Placebo-controlled, Phase Ⅲ Clinical Trial to Evaluate the Efficacy and Safety of DWJ211 in Patient With Moderate or Severe Submental Fat
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2019年5月15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
- 148
- 试验地点
- 1
- 主要终点
- PA-SMFRS, SA-SMFRS
研究概览
简要总结
Evaluate the efficacy and safety of DWJ211 in patient with moderate or severe submental fat
详细描述
DWJ211 is a injectable drug for improvement in the appearance of moderate to severe submental fat (SMF)
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
- Triple (Participant, Care Provider, 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
- 是
入选标准
- •Submental fat grade by the investigator as 2 or 3 using the PA-SMFRS and graded by the subject as 2 or 3 using the SA-SMFRS as determined on Visit
- •Dissatisfaction with the submental area expressed by the subject as a rating of 1~3 using the SSS as determinded on Visit
- •Less than 35kg/m2 in body mass index on Visit
- •Subject who will agree with the no treatment for the procedure that may affect to reduction or the submental fat.
排除标准
- •History of any intervention to treat SMF
- •History of trauma associated with the chin or neck areas that in the judgement of the investigator may affect evaluation of safety or efficacy of treatment.
- •Evidence of any cause of enlargement in the submental area.
- •History or current symptoms of dysphagia.
研究组 & 干预措施
Placebo group
Placebo Comparator
Inject the Drug into submental fat via subcutaneous
干预措施: Normal saline (Drug)
DWJ211 group
Experimental
Inject the Drug into submental fat via subcutaneous
干预措施: DWJ211 (Drug)
结局指标
主要结局
PA-SMFRS, SA-SMFRS
时间窗: 12 week after last treatment
Proportion of subject who simultaneously have at least a 1 grade, 2grade improvement from baseline on the PA-SMFRS, SA-SMFRS after the last treatment
次要结局
未报告次要终点
研究者
研究点 (1)
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