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Xeomin Cosmetic in the Management of Masseter

NCT ID: NCT03376464

Last Updated: 2017-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-06

Study Completion Date

2017-10-11

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Masseter Muscle Hypertrophy

Keywords

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Xeomin Cosmetic; Masseteric Hypertrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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single injection technique (SIT)

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

Group Type EXPERIMENTAL

Xeomin Cosmetic

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Xeomin Cosmetic

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Erevna Innovations Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andreas Nikolis, MD

Role: PRINCIPAL_INVESTIGATOR

Erevna Innovations Inc.

Other Identifiers

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2015-01-001

Identifier Type: -

Identifier Source: org_study_id