Xeomin Cosmetic in the Management of Masseter

Masseter Muscle Hypertrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03376464
• Other study ID #: 2015-01-001
• Status: Completed
• Phase: Phase 4
• First received: December 10, 2017
• Last updated: December 13, 2017
• Start date: November 6, 2015
• Est. completion date: October 11, 2017

Study information

• Verified date: December 2017
• Source: Erevna Innovations Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 11, 2017
• Est. primary completion date: January 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertrophy
• Masseter Muscle Hypertrophy

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Erevna Innovations Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events		Baseline to 20 weeks
Primary	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	Masseter photo-numeric aesthetic rating scales between SIT and MIT at 16 weeks in comparison to baseline.	Face shape and masseteric prominence rating	Baseline to 16 weeks
Secondary	Patient Satisfaction Questionnaire		Baseline to 20 weeks
Secondary	Global Aesthetic Improvement Scale		Baseline to 20 weeks