Xeomin Cosmetic in the Management of Masseter

Phase 4

Completed

• Conditions: Masseter Muscle Hypertrophy
• Interventions: Device: Xeomin Cosmetic

• Registration Number: NCT03376464
• Lead Sponsor: Erevna Innovations Inc.

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.

Study Timeline

• Study Start: 2015-11-06
• Primary Completion: 2017-01-31
• Study Completion: 2017-10-11
• Status Verified: 2017-12
• Study First Submitted: 2017-12-10
• Study First Submitted QC: 2017-12-13
• Last Update Submitted: 2017-12-13
• Study First Posted: 2017-12-18
• Last Update Posted: 2017-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
single injection technique (SIT)	Xeomin Cosmetic	40 U of Xeomin Cosmetic delivered directly into the region where the three masseter heads overlap.
multi-injection technique (MIT)	Xeomin Cosmetic	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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