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Xeomin Cosmetic in the Management of Masseter

Primary Purpose

Masseter Muscle Hypertrophy

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Xeomin Cosmetic

About this trial

This is an interventional treatment trial for Masseter Muscle Hypertrophy focused on measuring Xeomin Cosmetic;, Masseteric Hypertrophy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

single injection technique (SIT)

multi-injection technique (MIT)

Arm Description

40 U of Xeomin Cosmetic delivered directly into the region where the three masseter heads overlap.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Masseter photo-numeric aesthetic rating scales between SIT and MIT at 16 weeks in comparison to baseline.

Face shape and masseteric prominence rating

Patient Satisfaction Questionnaire

Global Aesthetic Improvement Scale

Full Information

NCT ID

NCT03376464

First Posted

December 10, 2017

Last Updated

December 13, 2017

Sponsor

Erevna Innovations Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03376464

Brief Title

Xeomin Cosmetic in the Management of Masseter

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Completed

Study Start Date

November 6, 2015 (Actual)

Primary Completion Date

January 31, 2017 (Actual)

Study Completion Date

October 11, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Erevna Innovations Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Masseter Muscle Hypertrophy

Keywords

Xeomin Cosmetic;, Masseteric Hypertrophy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

single injection technique (SIT)

Arm Type

Experimental

Arm Description

40 U of Xeomin Cosmetic delivered directly into the region where the three masseter heads overlap.

Arm Title

multi-injection technique (MIT)

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Xeomin Cosmetic

Intervention Description

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.

Primary Outcome Measure Information:

Title

Metric masseteric hypertrophy improvement outcomes between SIT and MIT at 16 weeks in comparison to baseline.

Description

Time Frame

Baseline to 16 weeks

Secondary Outcome Measure Information:

Title

Masseter photo-numeric aesthetic rating scales between SIT and MIT at 16 weeks in comparison to baseline.

Description

Face shape and masseteric prominence rating

Time Frame

Baseline to 16 weeks

Title

Patient Satisfaction Questionnaire

Time Frame

Baseline to 20 weeks

Title

Global Aesthetic Improvement Scale

Time Frame

Baseline to 20 weeks

Other Pre-specified Outcome Measures:

Title

Adverse Events

Time Frame

Baseline to 20 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andreas Nikolis, MD

Organizational Affiliation

Erevna Innovations Inc.

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Xeomin Cosmetic in the Management of Masseter

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