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This study is designed to evaluate the safety and effectiveness of administering BOTOX for the treatment of Masseter Muscle Prominence (MMP) in adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Placebo | Placebo Comparator | Placebo (normal saline) will be administered on Day 1 as bilateral intramuscular injections into the masseter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin Type A | Biological | Day 1 Administration of bilateral intramuscular injections into the masseter |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 90 |
| Achievement of MMPS-P Grade ≤ 3 on Day 90 |
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Inclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ALLERGAN INC. | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duplicate_Beacon Dermatology Inc /ID# 233018 | Calgary | Alberta | T3E 0B2 | Canada | ||
| Duplicate_Humphrey Cosmetic Dermatology /ID# 232764 |
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.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
The mITT population, consisting of all randomized subjects with at least 1 postbaseline MMPS assessment, comprised 370 subjects.
A total of 377 participants were enrolled and randomized into the study; 284 to BOTOX and 93 to Placebo. A total of 370 participants were included in the modified ITT (mITT) Population; 278 to BOTOX and 92 to Placebo. A participant was considered to have completed the study if he/she had at least completed the treatment visit and the end of study visit.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo was administered as bilateral intramuscular injections into the masseter on Day 1. |
| FG001 | BOTOX® | BOTOX ® was administered as bilateral intramuscular injections into the masseter on Day 1, with the possibility of 2 additional treatments |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 17, 2018 | Mar 24, 2025 |
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| Placebo | Other | Day 1 Administration of bilateral intramuscular injections of placebo (normal saline) into the masseter |
|
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. |
| 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. | 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. | Day 90 |
| Change From Baseline in Lower Facial Width (mm) at Day 90 | Calculated from standardized images, measured in millimeters (mm) | Day 90 |
| Median Duration of Effect for MMPS Responders | Median duration of effect for BOTOX-treated MMPS responders. | Up to Day 360 |
| Vancouver |
| British Columbia |
| V5Z 4E1 |
| Canada |
| Project Skin MD LTD /ID# 232763 | Vancouver | British Columbia | V6H 1K9 | Canada |
| Pacific Derm /ID# 233156 | Vancouver | British Columbia | V6H 4E1 | Canada |
| The Center For Dermatology /ID# 233001 | Richmond Hill | Ontario | L4B 1A5 | Canada |
| Peking University Third Hospital /ID# 233148 | Beijing | Beijing Municipality | 100191 | China |
| Duplicate_Peking Union Medical College Hospital /ID# 233072 | Beijing | Beijing Municipality | 100730 | China |
| Chinese PLA General Hospital /ID# 233158 | Beijing | Beijing Municipality | 100853 | China |
| Peking University First Hospital /ID# 232973 | Xicheng District | Beijing Municipality | 100034 | China |
| Tianjin Medical University General Hospital /ID# 232961 | Tianjin | Guizhou | 300052 | China |
| Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 233008 | Wuhan | Hubei | 430022 | China |
| Xiangya Hospital Central South University /ID# 233027 | Changsha | Hunan | 410008 | China |
| Nanjing Drum Tower Hospital /ID# 233016 | Nanjing | Jiangsu | 210008 | China |
| Zhongda Hospital Southeast University /ID# 232836 | Nanjing | Jiangsu | 210009 | China |
| Shanghai Ninth People's Hospital,Shanghai Jiaotong University School of Medicine /ID# 232656 | Shanghai | Shanghai Municipality | 200011 | China |
| Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 233087 | Xi’an | Shanxi | 710038 | China |
| West China Hospital, Sichuan University /ID# 233107 | Chengdu | Sichuan | 610041 | China |
| Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 233033 | Kaohsiung City | Keelung | 807 | Taiwan |
| National Taiwan University Hospital /ID# 233133 | Taipei City | Taipei | 100 | Taiwan |
| Taipei Medical University Hospital /ID# 233009 | Taipei | 11031 | Taiwan |
| Tri-Service General Hospital /ID# 233080 | Taipei | 11490 | Taiwan |
| mITT Population |
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| COMPLETED |
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| NOT COMPLETED |
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Modified Intent-to-Treat (mITT) Population
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo was administered as bilateral intramuscular injections into the masseter on Day 1 |
| BG001 | BOTOX® | BOTOX ® was administered as bilateral intramuscular injections into the masseter on Day 1, with the possibility of 2 additional treatments |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Baseline Masseter Muscle Prominence Scale (MMPS) | The investigator assessed the severity of the participant's masseter muscle prominence (MMP) using the MMPS 5-point scale ranging from 1=minimal to 5=very marked. Higher scores represent more severe outcomes. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | mITT Population | Posted | Number | 95% Confidence Interval | percentage of participants | Day 90 |
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| Secondary | 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. | mITT Population | Posted | Number | 95% Confidence Interval | percentage of participants | Day 90 |
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| Secondary | 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. | mITT Population | Posted | Number | 95% Confidence Interval | percentage of participants | Day 90 |
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| Secondary | 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. | mITT Population | Posted | Number | 95% Confidence Interval | percentage of participants | Day 90 |
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| Secondary | 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. | mITT Population | Posted | Number | 95% Confidence Interval | percentage of participants | Day 90 |
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| Secondary | Change From Baseline in Lower Facial Width (mm) at Day 90 | Calculated from standardized images, measured in millimeters (mm) | mITT Population | Posted | Least Squares Mean | Standard Error | millimeters (mm) | Day 90 |
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| Secondary | Median Duration of Effect for MMPS Responders | Median duration of effect for BOTOX-treated MMPS responders. | mITT Population | Posted | Median | 95% Confidence Interval | Days | Up to Day 360 |
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All-cause mortality and adverse event tables include events reported from the start of safety data collection/time of informed consent/enrollment (whichever study team prefers per protocol/study design) to the end of the study. The median time on follow-up (or mean time followed) was 539.0 and 540.0 Days for Placebo and BOTOX ®, respectively.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo was administered as bilateral intramuscular injections into the masseter on Day 1 | 0 | 93 | 4 | 93 | 19 | 93 |
| EG001 | BOTOX® | BOTOX ® was administered as bilateral intramuscular injections into the masseter on Day 1, with the possibility of 2 additional treatments | 0 | 283 | 11 | 283 | 54 | 283 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| VENTRICULAR EXTRASYSTOLES | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
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| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
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| GALLBLADDER POLYP | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
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| POST-ACUTE COVID-19 SYNDROME | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| PULMONARY TUBERCULOSIS | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| POST HERPETIC NEURALGIA | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
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| ABORTION OF ECTOPIC PREGNANCY | Pregnancy, puerperium and perinatal conditions | MedDRA 25.1 | Systematic Assessment |
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| ABORTION THREATENED | Pregnancy, puerperium and perinatal conditions | MedDRA 25.1 | Systematic Assessment |
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| FOETAL GROWTH RESTRICTION | Pregnancy, puerperium and perinatal conditions | MedDRA 25.1 | Systematic Assessment |
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| ENDOMETRIOSIS | Reproductive system and breast disorders | MedDRA 25.1 | Systematic Assessment |
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| FALLOPIAN TUBE CYST | Reproductive system and breast disorders | MedDRA 25.1 | Systematic Assessment |
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| LUNG OPACITY | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
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| NASAL SEPTUM DEVIATION | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
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| ABORTION INDUCED | Surgical and medical procedures | MedDRA 25.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NASOPHARYNGITIS | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| MASTICATION DISORDER | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| ABBVIE CALL CENTER | AbbVie | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 20, 2022 | Mar 24, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 5 = Very Marked |
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| Title | Denominators | Categories |
|---|
| MMPS ≥ 2-Grade Improvement |
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| MMPS Grade ≤ 3 |
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| MMPS ≥ 1-Grade Improvement |
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