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Xeomin Cosmetic in the Management of Masseter

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03376464
Recruitment Status : Completed
First Posted : December 18, 2017
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
Erevna Innovations Inc.

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.

Condition or disease Intervention/treatment Phase
Masseter Muscle Hypertrophy Device: Xeomin Cosmetic Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Evaluation of Xeomin Cosmetic in the Management of the Masseter Using Two Different Injection Techniques
Actual Study Start Date : November 6, 2015
Actual Primary Completion Date : January 31, 2017
Actual Study Completion Date : October 11, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cosmetics

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Adverse Events [ Time Frame: Baseline to 20 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03376464


Sponsors and Collaborators
Erevna Innovations Inc.
Investigators
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Principal Investigator: Andreas Nikolis, MD Erevna Innovations Inc.
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Responsible Party: Erevna Innovations Inc.
ClinicalTrials.gov Identifier: NCT03376464    
Other Study ID Numbers: 2015-01-001
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Erevna Innovations Inc.:
Xeomin Cosmetic;
Masseteric Hypertrophy
Additional relevant MeSH terms:
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Hypertrophy
Pathological Conditions, Anatomical
incobotulinumtoxinA
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents