Masseter Muscle ProminencePhase 3NCT04073303
BOTOX® Treatment for Adults With a Wide Lower Face Due to Masseter Muscle Prominence
A Phase 3 study testing Botulinum Toxin Type A in people with Masseter Muscle Prominence, run by AbbVie at 21 sites in 3 countries.
Trial summary
This study is designed to evaluate the safety and effectiveness of administering BOTOX for the treatment of Masseter Muscle Prominence (MMP) in adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Masseter Muscle Prominence
- What is being tested?
- Botulinum Toxin Type A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 377 participants
- Where
- 21 sitesin 3 countries
- Study dates
- 29 Aug 2019to 10 Nov 2022
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Masseter prominence at the Day 1 visit
- BMI ≤ 30 kg/m2 using the calculation: BMI = weight (kg)/[height (m)]2
- A female participant must be willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up periods
Who cannot join
- Any medical condition that may put the participant at increased medical risk with exposure to BOTOX, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
- An anticipated need for surgery or overnight hospitalization during the study
- An anticipated need for treatment with botulinum toxin of any serotype for any indication during the study (other than study intervention)
- History of dental or surgical procedure for lower facial shaping or masseter muscle reduction
- Prior mid-facial and/or lower facial treatment with nonpermanent soft tissue fillers, synthetic implantations, autologous fat transplantation, fat-reducing injectables, and/or skin-tightening laser treatments within 6 months prior to Day 1
- Prior exposure to botulinum toxin of any serotype to the masseter muscle or lower face at any time, or to any other part of the body within the 6 months prior to Day 1
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- History of temporomandibular joint disorder (TMJD)
- Masseter prominence due to other etiologies (eg, parotid gland infection, parotiditis, malignancy)
- Known allergy or sensitivity to any of the components of the study treatments or any materials used in the study procedures
- History of alcohol or drug abuse within 12 months of Day 1
Trial locations and contacts
21 sites in 3 countries.
21 sites in 3 countries
China12 sites
Peking University Third Hospital /ID# 233148
Beijing, Beijing Municipality, 100191
Duplicate_Peking Union Medical College Hospital /ID# 233072
Beijing, Beijing Municipality, 100730
Chinese PLA General Hospital /ID# 233158
Beijing, Beijing Municipality, 100853
Xiangya Hospital Central South University /ID# 233027
Changsha, Hunan, 410008
West China Hospital, Sichuan University /ID# 233107
Chengdu, Sichuan, 610041
Nanjing Drum Tower Hospital /ID# 233016
Nanjing, Jiangsu, 210008
Zhongda Hospital Southeast University /ID# 232836
Nanjing, Jiangsu, 210009
Shanghai Ninth People's Hospital,Shanghai Jiaotong University School of Medicine /ID# 232656
Shanghai, Shanghai Municipality, 200011
Tianjin Medical University General Hospital /ID# 232961
Tianjin, Guizhou, 300052
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 233008
Wuhan, Hubei, 430022
Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 233087
Xi’an, Shanxi, 710038
Peking University First Hospital /ID# 232973
Xicheng District, Beijing Municipality, 100034
Canada5 sites
Duplicate_Beacon Dermatology Inc /ID# 233018
Calgary, Alberta, T3E 0B2
The Center For Dermatology /ID# 233001
Richmond Hill, Ontario, L4B 1A5
Duplicate_Humphrey Cosmetic Dermatology /ID# 232764
Vancouver, British Columbia, V5Z 4E1
Project Skin MD LTD /ID# 232763
Vancouver, British Columbia, V6H 1K9
Pacific Derm /ID# 233156
Vancouver, British Columbia, V6H 4E1
Taiwan4 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 233033
Kaohsiung City, Keelung, 807
Taipei Medical University Hospital /ID# 233009
Taipei, 11031
Tri-Service General Hospital /ID# 233080
Taipei, 11490
National Taiwan University Hospital /ID# 233133
Taipei City, Taipei, 100
About this study
Official title: BOTOX® (onabotulinumtoxinA) Treatment of Masseter Muscle Prominence: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study
This study is designed to evaluate the safety and effectiveness of administering BOTOX for the treatment of Masseter Muscle Prominence (MMP) in adults.
- Conditions
- Masseter Muscle Prominence
- Being tested
- Botulinum Toxin Type A, Placebo
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 OnabotulinumtoxinA, BOTOX®
Day 1 Administration of bilateral intramuscular injections into the masseter
PlaceboOther
Day 1 Administration of bilateral intramuscular injections of placebo (normal saline) into the masseter
| Study group | Role | What they receive |
|---|---|---|
| Botulinum Toxin Type A (BOTOX®) | Active comparator | Botulinum Toxin Type A (BOTOX ®) will be administered on Day 1 as bilateral intramuscular injections into the masseter with the possibility of 2 additional treatments Receives: Biological: Botulinum Toxin Type A |
| Placebo | Placebo comparator | Placebo (normal saline) will be administered on Day 1 as bilateral intramuscular injections into the masseter Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of ≥ 2-Grade Improvement From Baseline on the Masseter Muscle Prominence Scale (MMPS) at Day 90
Proportion of participants who achieve ≥ 2-grade improvement from baseline at Day 90, per investigator assessments of MMP using the Masseter Muscle Prominence Scale (MMPS).
MMPS ranges from 1 = minimal to 5 = very marked.
Measured: Day 90
Secondary outcomes (6)
Achievement of MMPS Grade ≤ 3 at Day 90
Proportion of participants who achieve MMPS Grade of ≤ 3 at Day 90, per investigator assessments of MMP using the Masseter Muscle Prominence Scale (MMPS).
MMPS ranges from 1 = minimal to 5 = very marked.
Measured: Day 90
Achievement of MMPS-P Grade ≤ 3 on Day 90
Proportion of participants who achieve MMPS-P Grade ≤ 3 at Day 90, according to participant, per Masseter Muscle Prominence Scale-Participant (MMPS-P)
MMPS-P ranges from 1 = not at all pronounced to 5 = very pronounced.
Measured: Day 90
Achievement of MMPS-P ≥ 2-Grade Improvement From Baseline at Day 90
Proportion of participants who achieve ≥ 2-grade improvement from baseline at Day 90, per Masseter Muscle Prominence Scale-Participant (MMPS-P)
MMPS-P ranges from 1 = not at all pronounced to 5 = very pronounced.
Measured: Day 90
Achievement of PSAC Grade ≥ 1 (at Least Minimally Improved From Baseline) on Day 90
Proportion of participants who achieve Grade ≥ 1 on Participant Self-Assessment of Change (PSAC) (at least minimally improved from baseline) at Day 90
PSAC ranges from 3 = much improved to -3 = much worse.
Measured: Day 90
Change From Baseline in Lower Facial Width (mm) at Day 90
Calculated from standardized images, measured in millimeters (mm)
Measured: Day 90
Median Duration of Effect for MMPS Responders
Median duration of effect for BOTOX-treated MMPS responders.
Measured: Up to Day 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2019
- Study start29 Aug 2019
- Primary completion10 Nov 2022
- Study completion10 Nov 2022
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 ProminenceStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 377 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ALLERGAN INC., Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04073303
- Sponsor's protocol ID
- 1789-301-008
- Status last verified
- Apr 2025
- First submitted
- 22 Aug 2019
- Last updated
- 6 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BOTOX® (onabotulinumtoxinA) Treatment of Masseter Muscle Prominence: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT04073303
- Acronym / sponsor ID
- 1789-301-008
- Conditions
- Masseter Muscle Prominence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 377 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 29 Aug 2019 (actual)
- Primary completion
- 10 Nov 2022 (actual)
- Study completion
- 10 Nov 2022 (actual)
- First posted
- 29 Aug 2019 (actual)
- Results
- Posted 6 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the safety and effectiveness of administering BOTOX for the treatment of Masseter Muscle Prominence (MMP) in adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulinum Toxin Type A (BOTOX®) | Active comparator | Biological: Botulinum Toxin Type ABotulinum Toxin Type A (BOTOX ®) will be administered on Day 1 as bilateral intramuscular injections into the masseter with the possibility of 2 additional treatments |
| Placebo | Placebo comparator | Other: PlaceboPlacebo (normal saline) will be administered on Day 1 as bilateral intramuscular injections into the masseter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Masseter prominence at the Day 1 visit
- BMI ≤ 30 kg/m2 using the calculation: BMI = weight (kg)/[height (m)]2
- A female participant must be willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up periods
Key exclusion criteria (10 listed)
- Any medical condition that may put the participant at increased medical risk with exposure to BOTOX, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
- An anticipated need for surgery or overnight hospitalization during the study
- An anticipated need for treatment with botulinum toxin of any serotype for any indication during the study (other than study intervention)
- History of dental or surgical procedure for lower facial shaping or masseter muscle reduction
- Prior mid-facial and/or lower facial treatment with nonpermanent soft tissue fillers, synthetic implantations, autologous fat transplantation, fat-reducing injectables, and/or skin-tightening laser treatments within 6 months prior to Day 1
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: OnabotulinumtoxinA, BOTOX®Day 1 Administration of bilateral intramuscular injections into the masseter | Biological | Botulinum Toxin Type A (BOTOX®) |
| PlaceboDay 1 Administration of bilateral intramuscular injections of placebo (normal saline) into the masseter | Other | Placebo |
Primary outcome
Achievement of ≥ 2-Grade Improvement From Baseline on the Masseter Muscle Prominence Scale (MMPS) at Day 90
Time frame: Day 90
Proportion of participants who achieve ≥ 2-grade improvement from baseline at Day 90, per investigator assessments of MMP using the Masseter Muscle Prominence Scale (MMPS). MMPS ranges from 1 = minimal to 5 = very marked.
6 secondary outcomes
Achievement of MMPS Grade ≤ 3 at Day 90
Time frame: Day 90
Achievement of MMPS-P Grade ≤ 3 on Day 90
Time frame: Day 90
Achievement of MMPS-P ≥ 2-Grade Improvement From Baseline at Day 90
Time frame: Day 90
Achievement of PSAC Grade ≥ 1 (at Least Minimally Improved From Baseline) on Day 90
Time frame: Day 90
Change From Baseline in Lower Facial Width (mm) at Day 90
Time frame: Day 90
Median Duration of Effect for MMPS Responders
Time frame: Up to Day 360
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
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.
ALLERGAN INC. study director
Allergan
21 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botulinum Toxin Type A in people with Masseter Muscle Prominence, run by AbbVie at 21 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 3 inclusion and 10 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 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in China, Canada, 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 6 May 2025). 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?
Achievement of ≥ 2-Grade Improvement From Baseline on the Masseter Muscle Prominence Scale (MMPS) at Day 90 (time frame: Day 90). 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 6 May 2025.