Xeomin Cosmetic in the Management of Masseter

NCT03376464 | Completed Phase 4

• 1 other identifier: 2015-01-001
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Masseter Muscle Hypertrophy

Keywords

Xeomin Cosmetic;; Masseteric Hypertrophy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  Baseline to 16 weeks

• Patient Satisfaction Questionnaire

  Baseline to 20 weeks

• Global Aesthetic Improvement Scale

  Baseline to 20 weeks

Other Outcomes (1)

• Adverse Events

  Baseline to 20 weeks

Study Arms (2)

single injection technique (SIT)

EXPERIMENTAL

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

Device: Xeomin Cosmetic

multi-injection technique (MIT)

EXPERIMENTAL

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

Interventions

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.

multi-injection technique (MIT); single injection technique (SIT)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Erevna Innovations Inc.: lead

MeSH Terms

Conditions

Masticatory Muscles, Hypertrophy of

Study Officials

• Andreas Nikolis, MD

  Erevna Innovations Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2017
• First Posted: December 18, 2017
• Study Start: November 6, 2015
• Primary Completion: January 31, 2017
• Study Completion: October 11, 2017
• Last Updated: December 18, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share