Masseter Muscle Hypertrophy
Conditions
Keywords
Xeomin Cosmetic;, Masseteric Hypertrophy
Brief summary
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
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.
Interventions
DEVICEXeomin Cosmetic
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.
Sponsors
Erevna Innovations Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. At the time of consent, women over the age of 18 years old. 2. Patients with established hypertrophy of the masseters, palpable and visible. 3. Accepted the obligation not to receive any other facial procedures through the 6-month follow-up. 4. Understood and accepted the obligation and would be logistically able to appear for all scheduled follow-up visits. 5. No previous facial fillers for a period of 6 months prior to this study. 6. No previous facial fillers along the jawline for 18 months 7. Capable of providing informed consent. 8. No previous botulinum toxin type A treatment for masseteric hypertrophy in the last 12 months.
Exclusion criteria
1. Current Pregnancy or lactation 2. Hypersensitivity to Xeomin 3. Generalized disorders of muscle activity (e.g. myasthenia gravis, Lambert Eaton syndrome) 4. Presence of infection at the site of injection 5. Inability to comply with follow-up and abstain from facial injections during the study period 6. Patients with a score of 2 or greater on the Merz Aesthetics Scale for the Jawline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metric masseteric hypertrophy improvement outcomes between SIT and MIT at 16 weeks in comparison to baseline. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Masseter photo-numeric aesthetic rating scales between SIT and MIT at 16 weeks in comparison to baseline. | Baseline to 16 weeks | Face shape and masseteric prominence rating |
| Patient Satisfaction Questionnaire | Baseline to 20 weeks | — |
| Global Aesthetic Improvement Scale | Baseline to 20 weeks | — |
Other
| Measure | Time frame |
|---|---|
| Adverse Events | Baseline to 20 weeks |
Outcome results
None listed