Clinical trial NCT03376464: Xeomin Cosmetic in the Management of Masseter
Official title: Prospective Evaluation of Xeomin Cosmetic in the Management of the Masseter Using Two Different Injection Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Masseter Muscle Hypertrophy
Keywords: Xeomin Cosmetic;
Masseteric Hypertrophy
Lead sponsor: Erevna Innovations Inc.
Sponsor class: OTHER
First posted: 2017-12-18
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Metric masseteric hypertrophy improvement outcomes between SIT and MIT at 16 weeks in comparison to baseline.
timeFrame: Baseline to 16 weeks
Secondary outcomes:
measure: Masseter photo-numeric aesthetic rating scales between SIT and MIT at 16 weeks in comparison to baseline.
timeFrame: Baseline to 16 weeks
measure: Patient Satisfaction Questionnaire
timeFrame: Baseline to 20 weeks
measure: Global Aesthetic Improvement Scale
timeFrame: Baseline to 20 weeks
Other outcomes:
measure: Adverse Events
timeFrame: Baseline to 20 weeks
Locations:
Study officials:
affiliation: Erevna Innovations Inc.
name: Andreas Nikolis, MD
role: PRINCIPAL_INVESTIGATOR
References: