Xeomin Cosmetic in the Management of Masseter

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

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.

Study Overview

• Status: Completed
• Conditions: Masseter Muscle Hypertrophy
• Intervention / Treatment: Device: 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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: single injection technique (SIT); 40 U of Xeomin Cosmetic delivered directly into the region where the three masseter heads overlap.	Device: Xeomin 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.
EXPERIMENTAL: 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.	Device: Xeomin 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Time Frame
Adverse Events	Baseline to 20 weeks

Collaborators and Investigators

• Sponsor: Erevna Innovations Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 6, 2015
• Primary Completion (ACTUAL): January 31, 2017
• Study Completion (ACTUAL): October 11, 2017

Study Registration Dates

• First Submitted: December 10, 2017
• First Submitted That Met QC Criteria: December 13, 2017
• First Posted (ACTUAL): December 18, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 18, 2017
• Last Update Submitted That Met QC Criteria: December 13, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Xeomin Cosmetic;; Masseteric Hypertrophy
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hypertrophy; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; incobotulinumtoxinA
• Other Study ID Numbers: 2015-01-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No