Status:
COMPLETED
Xeomin Cosmetic in the Management of Masseter
Lead Sponsor:
Erevna Innovations Inc.
Conditions:
Masseter Muscle Hypertrophy
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
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 wa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 6 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 11 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03376464
Start Date
November 6 2015
End Date
October 11 2017
Last Update
December 18 2017
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