Evaluating the Effectiveness and Safety of Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.) for the Management of Submental Fat
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of Participants With A Minimum of One Grade Improvement in the Standard Submental Fat (SMF) Assessment Grading
研究概览
简要总结
Submental fat (SMF) is a factor affecting beauty that makes people feel uncomfortable about themselves. In 2015, deoxycholic acid with the brand name KYBELLA® was approved by the American FDA for treatment of submental fat. The purpose of this study is to evaluate the safety and effectiveness of deoxycholic acid injection with the brand name Embella®, manufactured by Espad Pharmed Company, for treatment of this condition.
Research Objectives
Primary objective:
Effectiveness and safety of Embella® in reducing submental fat
Secondary objective:
Effectiveness assessment of Embella® in improving SMF grading Effectiveness assessment of Embella® in reducing submental fat diameter
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years.
- •Individuals with unwanted submental fat of any severity.
- •Ability to comply with visit schedules and study procedures.
- •Signed informed consent form and agreement to a 3-month follow-up.
排除标准
- •Any previous intervention for the treatment of submental fat (SMF).
- •Specific anatomical features or previous damage to the intervention site (e.g., scars, liposuction, swallowing difficulties, enlarged thyroid or lymph nodes) that could interfere with the assessment of intervention outcomes.
- •Evidence of submental enlargement due to reasons other than SMF.
- •History of dysphagia.
- •Body mass index (BMI) > 30 kg/m².
- •Individuals currently on a weight loss program.
- •History of allergy to any components of the drug or local anesthetics.
- •Presence of any inflammation, active infection, unhealed wounds, or skin lesions in the injection area.
- •Use of any anticoagulants, NSAIDs, or any other medications that increase the risk of coagulation disorders within 7 days before injection.
- •Unrealistic expectations.
- •Pregnant or breastfeeding women.
- •Individuals on sodium-restricted diets, such as those with uncontrolled hypertension.
结局指标
主要结局
Number of Participants With A Minimum of One Grade Improvement in the Standard Submental Fat (SMF) Assessment Grading
时间窗: Week 4 after the last injection, up to 12 weeks, and week 12 after the last injection, up to 20 weeks
The scales are from 0 to 4, 0 indicating no localized submental fat and 4 indicating extreme submental convexity
次要结局
- Measurement of Submental Fat Thickness(Week 4 after the last injection, up to 12 weeks, and week 12 after the last injection, up to 20 weeks)
- Pain Intensity Was Assessed Using the VAS From 0 to 10(Day 1, week 4 and week 8)
- Subject Satisfaction Was Assessed Using the VAS From 0 to 10(Week 4 after the last injection, up to 12 weeks, and week 12 after the last injection, up to 20 weeks)
- Number of Participants With Adverse Events Immediately After the Injections and During the Study Period(Immediately after all of the injections and at week 4 after the last injection, up to 12 weeks, and week 12 after the last injection, up to 20 weeks)