Masseter Muscle HypertrophyPhase 2NCT02010775
Botulinum Toxin Type A (BOTOX®) Treatment of Masseter Muscle Hypertrophy
A Phase 2 study testing botulinum toxin Type A and Normal saline in people with Masseter Muscle Hypertrophy, run by Allergan at 14 sites in 3 countries.
Trial summary
This study will evaluate the safety and efficacy of a range of doses of botulinum toxin Type A (BOTOX®) for the treatment of patients with bilateral Masseter Muscle Hypertrophy (MMH). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Masseter Muscle Hypertrophy
- What is being tested?
- botulinum toxin Type A and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 187 participants
- Where
- 14 sitesin 3 countries
- Study dates
- 20 Jan 2014to 29 Nov 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- -Participants with Masseter Muscle Hypertrophy
Who cannot join
- Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
- Prior botulinum toxin treatment of any serotype to the masseter muscle or lower face
- History of dental or surgical procedure for lower facial shaping or masseter muscle reduction
- History of or current temporomandibular joint disorder (TMJD)
Trial locations and contacts
14 sites in 3 countries.
14 sites in 3 countries
Canada6 sites
Arthur Swift Research Inc.
Montreal, Quebec, H3Z 1B7
Dr. Jean Carruthers Cosmetic Surgery, Inc.
Vancouver, British Columbia, V5Z 4E1
Dr. Shannon Humphrey Inc.
Vancouver, British Columbia, V5Z 4E1
Project Skin MD
Vancouver, British Columbia, V6H 1K9
Pacific Dermaesthetics
Vancouver, British Columbia, V6H 4E1
Bertucci MedSpa
Woodbridge, Ontario, L4L 8E2
Australia4 sites
Shape Clinic
Darlinghurst, New South Wales, 2010
Esteem Beauty & Day Spa
Main Beach, Queensland, 4217
The Rose Medical & Aesthetic Centre
North Fremantle, Western Australia, 6159
Central Sydney Dermatology
Sydney, New South Wales, 2000
Taiwan4 sites
Kaohsiung Medical University Hospital
Kaohsiung City, 80735
National Taiwan University Hospital
Taipei, 10041
Taipei Chang Gung Memorial Hospital of CGMF
Taipei, 10507
Tri-Service General Hospital
Taipei, 11411
About this study
Official title: BOTOX® Treatment of Masseter Muscle Hypertrophy
This study will evaluate the safety and efficacy of a range of doses of botulinum toxin Type A (BOTOX®) for the treatment of patients with bilateral Masseter Muscle Hypertrophy (MMH).
- Conditions
- Masseter Muscle Hypertrophy
- Being tested
- botulinum toxin Type A, Normal saline
- 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.
botulinum toxin Type ABiological
Also called BOTOX®, onabotulinumtoxinA
Botulinum toxin Type A (BOTOX®) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
Normal salineDrug
Normal saline (placebo) administered intramuscularly to the bilateral masseter muscles.
| Study group | Role | What they receive |
|---|---|---|
| BOTOX® 24U | Active comparator | Botulinum Toxin Type A (BOTOX®) 24U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable. Receives: Biological: botulinum toxin Type A |
| BOTOX® 48U | Active comparator | Botulinum Toxin Type A (BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable. Receives: Biological: botulinum toxin Type A |
| BOTOX® 72U | Active comparator | Botulinum Toxin Type A (BOTOX®) 72U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable. Receives: Biological: botulinum toxin Type A |
| BOTOX® 96U | Active comparator | Botulinum Toxin Type A (BOTOX®) 96U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable. Receives: Biological: botulinum toxin Type A |
| Placebo | Placebo comparator | Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Lower Facial Volume Using VECTRA 3D Images
Lower facial volume was calculated from 3-dimensional (3D) images captured with the VECTRA M3 3D Stereophotogrammetry imaging system and was analyzed using computer assisted systems and predetermined facial landmarks. The difference in volume was measured between the select region of the baseline surface 3D model and the select region of the posttreatment surface 3D model. A negative change from Baseline (decrease in volume) indicates improvement.
Measured: Baseline (Day 1) to Day 90 of Treatment Cycle 1
Secondary outcomes (1)
Percentage of Participants Who Achieved a Masseter Muscle Prominence Scale (MMPS) Grade ≤ 3 as Assessed by the Investigator
The investigator used visual inspection and palpation to grade the prominence of the participant's masseter muscle on the left and right sides of the face using the MMPS where: 1=minimal prominence (best), 2=mild prominence, 3=moderate prominence, 4=marked prominence, 5=very marked prominence (worst). The percentage of participants with grade 3 or less is reported.
Measured: Day 90 of Treatment Cycle 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study start20 Jan 2014
- Primary completion7 Mar 2017
- Study completion29 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Beta Bowen, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02010775
- Sponsor's protocol ID
- 191622-130
- Status last verified
- Feb 2019
- First submitted
- 10 Dec 2013
- Last updated
- 28 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BOTOX® Treatment of Masseter Muscle Hypertrophy
- ClinicalTrials.gov ID
- NCT02010775
- Acronym / sponsor ID
- 191622-130
- Conditions
- Masseter Muscle Hypertrophy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2014 (actual)
- Primary completion
- 7 Mar 2017 (actual)
- Study completion
- 29 Nov 2017 (actual)
- First posted
- 13 Dec 2013 (estimated)
- Results
- Posted 28 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and efficacy of a range of doses of botulinum toxin Type A (BOTOX®) for the treatment of patients with bilateral Masseter Muscle Hypertrophy (MMH).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| BOTOX® 24U | Active comparator | Biological: botulinum toxin Type ABotulinum Toxin Type A (BOTOX®) 24U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable. |
| BOTOX® 48U | Active comparator | Biological: botulinum toxin Type ABotulinum Toxin Type A (BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable. |
| BOTOX® 72U | Active comparator | Biological: botulinum toxin Type ABotulinum Toxin Type A (BOTOX®) 72U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable. |
| BOTOX® 96U | Active comparator | Biological: botulinum toxin Type ABotulinum Toxin Type A (BOTOX®) 96U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable. |
| Placebo | Placebo comparator | Drug: Normal salinePlacebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -Participants with Masseter Muscle Hypertrophy
Key exclusion criteria (4 listed)
- Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
- Prior botulinum toxin treatment of any serotype to the masseter muscle or lower face
- History of dental or surgical procedure for lower facial shaping or masseter muscle reduction
- History of or current temporomandibular joint disorder (TMJD)
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 |
|---|---|---|
| botulinum toxin Type AAlso: BOTOX®, onabotulinumtoxinABotulinum toxin Type A (BOTOX®) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable. | Biological | BOTOX® 24U, BOTOX® 48U, BOTOX® 72U, BOTOX® 96U |
| Normal salineNormal saline (placebo) administered intramuscularly to the bilateral masseter muscles. | Drug | Placebo |
Primary outcome
Change From Baseline in Lower Facial Volume Using VECTRA 3D Images
Time frame: Baseline (Day 1) to Day 90 of Treatment Cycle 1
Lower facial volume was calculated from 3-dimensional (3D) images captured with the VECTRA M3 3D Stereophotogrammetry imaging system and was analyzed using computer assisted systems and predetermined facial landmarks. The difference in volume was measured between the select region of the baseline surface 3D model and the select region of the posttreatment surface 3D model. A negative change from Baseline (decrease in volume) indicates improvement.
1 secondary outcome
Percentage of Participants Who Achieved a Masseter Muscle Prominence Scale (MMPS) Grade ≤ 3 as Assessed by the Investigator
Time frame: Day 90 of Treatment Cycle 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Beta Bowen study director
Allergan
14 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing botulinum toxin Type A and Normal saline in people with Masseter Muscle Hypertrophy, run by Allergan at 14 sites in 3 countries.
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 1 inclusion and 4 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 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Canada, Australia, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Lower Facial Volume Using VECTRA 3D Images (time frame: Baseline (Day 1) to Day 90 of Treatment Cycle 1). 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 28 May 2019.