Xeomin Cosmetic in the Management of Masseter

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prospective Evaluation of Xeomin Cosmetic in the Management of the Masseter Using Two Different Injection Techniques

Conditions
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Masseter Muscle Hypertrophy

Intervention / Treatment
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* Device: Xeomin Cosmetic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single injection technique (SIT)<br>40 U of Xeomin Cosmetic delivered directly into the region where the three masseter heads overlap. | Device: Xeomin Cosmetic<br>* Xeomin Cosmetic is the purest commercially available botulinum toxin type A available to date. It has been approved by Health Canada since 2012 for the temporary improvement in the appearance of moderate to severe glabellar lines.<br>|
| Experimental: multi-injection technique (MIT)<br>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. | Device: Xeomin Cosmetic<br>* Xeomin Cosmetic is the purest commercially available botulinum toxin type A available to date. It has been approved by Health Canada since 2012 for the temporary improvement in the appearance of moderate to severe glabellar lines.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metric masseteric hypertrophy improvement outcomes between SIT and MIT at 16 weeks in comparison to baseline. | 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). | Baseline to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Masseter photo-numeric aesthetic rating scales between SIT and MIT at 16 weeks in comparison to baseline. | Face shape and masseteric prominence rating | Baseline to 16 weeks | 
| Patient Satisfaction Questionnaire |  | Baseline to 20 weeks | 
| Global Aesthetic Improvement Scale |  | Baseline to 20 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Xeomin Cosmetic;, Masseteric Hypertrophy