Masseter Muscle HypertrophyPhase 4NCT03376464
Xeomin Cosmetic in the Management of Masseter
A Phase 4 study testing Xeomin Cosmetic in people with Masseter Muscle Hypertrophy, run by Erevna Innovations Inc..
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Masseter Muscle Hypertrophy
- What is being tested?
- Xeomin Cosmetic
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 6 Nov 2015to 11 Oct 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: Prospective Evaluation of Xeomin Cosmetic in the Management of the Masseter Using Two Different Injection Techniques
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.
Read the 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.
- Conditions
- Masseter Muscle Hypertrophy
- Being tested
- Xeomin Cosmetic
- Keywords
- Xeomin Cosmetic;, Masseteric Hypertrophy
- Medical subject headings
- Masticatory Muscles, Hypertrophy of
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xeomin CosmeticDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| single injection technique (SIT) | Experimental | 40 U of Xeomin Cosmetic delivered directly into the region where the three masseter heads overlap. Receives: Device: Xeomin Cosmetic |
| multi-injection technique (MIT) | Experimental | 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. Receives: Device: Xeomin Cosmetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline to 16 weeks
Secondary outcomes (3)
Masseter photo-numeric aesthetic rating scales between SIT and MIT at 16 weeks in comparison to baseline.
Face shape and masseteric prominence rating
Measured: Baseline to 16 weeks
Patient Satisfaction Questionnaire
Measured: Baseline to 20 weeks
Global Aesthetic Improvement Scale
Measured: Baseline to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start6 Nov 2015
- Primary completion31 Jan 2017
- Study completion11 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Masseter Muscle HypertrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erevna Innovations Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Nikolis, MD, Principal investigator, Erevna Innovations Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03376464
- Sponsor's protocol ID
- 2015-01-001
- Status last verified
- Dec 2017
- First submitted
- 10 Dec 2017
- Last updated
- 18 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Xeomin Cosmetic in the Management of the Masseter Using Two Different Injection Techniques
- ClinicalTrials.gov ID
- NCT03376464
- Acronym / sponsor ID
- 2015-01-001
- Conditions
- Masseter Muscle Hypertrophy
- Keywords
- Xeomin Cosmetic;, Masseteric Hypertrophy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Erevna Innovations Inc.University, hospital or other
- Study start
- 6 Nov 2015 (actual)
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 11 Oct 2017 (actual)
- First posted
- 18 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single injection technique (SIT) | Experimental | Device: Xeomin Cosmetic40 U of Xeomin Cosmetic delivered directly into the region where the three masseter heads overlap. |
| multi-injection technique (MIT) | Experimental | Device: Xeomin CosmeticA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xeomin CosmeticXeomin 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. | Device | multi-injection technique (MIT), single injection technique (SIT) |
Primary outcome
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).
3 secondary outcomes
Masseter photo-numeric aesthetic rating scales between SIT and MIT at 16 weeks in comparison to baseline.
Time frame: Baseline to 16 weeks
Patient Satisfaction Questionnaire
Time frame: Baseline to 20 weeks
Global Aesthetic Improvement Scale
Time frame: Baseline to 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2017.
- Individual participant dataSharing planned: No
Related trials for Masseter Muscle Hypertrophy
RecruitingObservational study
Evaluation of the Effect of Adenoid Hypertrophy on the Masseter Muscle in Children: A Comparative Ultrasonographic Study
Adenoid Hypertrophy, Masseter Muscle
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Nikolis, MD principal investigator
Erevna Innovations Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Xeomin Cosmetic in people with Masseter Muscle Hypertrophy, run by Erevna Innovations Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metric masseteric hypertrophy improvement outcomes between SIT and MIT at 16 weeks in comparison to baseline. (time frame: Baseline to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2017.