CompletedPhase 4

Xeomin Cosmetic in the Management of Masseter

30 participantsStarted 2015-11-06

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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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

What they're measuring

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

Timeframe: Baseline to 16 weeks

Trial details

NCT IDNCT03376464

SponsorErevna Innovations Inc.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-01-31

View on ClinicalTrials.gov More Masseter Muscle Hypertrophy trials