Prospective Evaluation of Xeomin Cosmetic in the Management of the Masseter Using Two Different Injection Techniques
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Metric masseteric hypertrophy improvement outcomes between SIT and MIT at 16 weeks in comparison to baseline.
研究概览
简要总结
The goal of this study was to evaluate the efficacy and safety of two injection techniques in the management of masseteric hypertrophy using Xeomin Cosmetic.
详细描述
Background: Xeomin Cosmetic has been used previously in the management of masseteric hypertrophy. However, a standardized injection technique has not been established. The goal of the present study was to evaluate the efficacy and safety of two injection techniques in the management of masseteric hypertrophy using Xeomin Cosmetic.
Methods: Thirty female patients with masseteric hypertrophy were recruited and evenly randomized to receive bilateral treatments of either 1) a single injection technique (SIT), or 2) a multi-injection technique (MIT). Improvement of masseteric hypertrophy was assessed at Week 16 using standardized measurements and photographs. Patients completed a 5-point satisfaction questionnaire while physicians the global aesthetic improvement scale (GAIS) and 10-point photonumeric masseter prominence rating scale.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •At the time of consent, women over the age of 18 years old.
- •Patients with established hypertrophy of the masseters, palpable and visible.
- •Accepted the obligation not to receive any other facial procedures through the 6-month follow-up.
- •Understood and accepted the obligation and would be logistically able to appear for all scheduled follow-up visits.
- •No previous facial fillers for a period of 6 months prior to this study.
- •No previous facial fillers along the jawline for 18 months
- •Capable of providing informed consent.
- •No previous botulinum toxin type A treatment for masseteric hypertrophy in the last 12 months.
排除标准
- •Current Pregnancy or lactation
- •Hypersensitivity to Xeomin
- •Generalized disorders of muscle activity (e.g. myasthenia gravis, Lambert Eaton syndrome)
- •Presence of infection at the site of injection
- •Inability to comply with follow-up and abstain from facial injections during the study period
- •Patients with a score of 2 or greater on the Merz Aesthetics Scale for the Jawline
研究组 & 干预措施
single injection technique (SIT)
40 U of Xeomin Cosmetic delivered directly into the region where the three masseter heads overlap.
干预措施: Xeomin Cosmetic (Device)
multi-injection technique (MIT)
A distribution of 40 U (8 U distributed in 5 different areas) of Xeomin Cosmetic over the width of the masseter while respecting the upper limit of the anterior border of the masseter and the inferior insertion of the masseter. The injections are separated by a 1cm distance and the dose is equally distributed across these sites.
干预措施: Xeomin Cosmetic (Device)
结局指标
主要结局
Metric masseteric hypertrophy improvement outcomes between SIT and MIT at 16 weeks in comparison to baseline.
时间窗: Baseline to 16 weeks
The difference in physician assessed efficacy using standardized masseter improvement measurements between two different injection techniques at 16 weeks (visit 4) in comparison to baseline (visit 2).
次要结局
- Global Aesthetic Improvement Scale(Baseline to 20 weeks)
- Masseter photo-numeric aesthetic rating scales between SIT and MIT at 16 weeks in comparison to baseline.(Baseline to 16 weeks)
- Patient Satisfaction Questionnaire(Baseline to 20 weeks)