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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single injection technique (SIT) | Experimental | 40 U of Xeomin Cosmetic delivered directly into the region where the three masseter heads overlap. |
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| multi-injection technique (MIT) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xeomin Cosmetic | Device | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Baseline to 20 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Nikolis, MD | Erevna Innovations Inc. | Principal Investigator |
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| ID | Term |
|---|---|
| C563600 | Masticatory Muscles, Hypertrophy of |
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| Baseline to 20 weeks |
| Global Aesthetic Improvement Scale | Baseline to 20 weeks |