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Completed

NCT Number: NCT03376464

Xeomin Cosmetic in the Management of Masseter

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: Baseline to 16 weeks

    Face shape and masseteric prominence rating

  2. Patient Satisfaction Questionnaire

    Time frame: Baseline to 20 weeks

  3. Global Aesthetic Improvement Scale

    Time frame: Baseline to 20 weeks

Other outcomes

  1. Adverse Events

    Time frame: Baseline to 20 weeks

Sponsors and collaborators

Lead sponsor

Erevna Innovations Inc.

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 18, 2017
Registry last updated
Dec 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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