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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Placebo | Placebo Comparator | Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| botulinum toxin Type A | Biological | Botulinum toxin Type A (BOTOX®) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Day 1) to Day 90 of Treatment Cycle 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
-Participants with Masseter Muscle Hypertrophy
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beta Bowen | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shape Clinic | Darlinghurst | New South Wales | 2010 | Australia | ||
| Central Sydney Dermatology |
Not provided
| Label | URL |
|---|---|
| More Information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | BOTOX® 96U | 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. |
| FG001 | BOTOX® 72U | 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. |
| FG002 | BOTOX® 48U | 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. |
| FG003 | BOTOX® 24U | 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. |
| FG004 | Placebo | Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Modified intent-to-treat (mITT) population included all randomized participants who received at least 1 injection of study treatment and had at least 1 follow-up visit.
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| ID | Title | Description |
|---|---|---|
| BG000 | BOTOX® 96U | 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. |
| BG001 | BOTOX® 72U |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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. | Participants from the mITT population, all randomized participants who received at least 1 injection of study treatment and had at least 1 follow-up visit, with data available for analysis at Day 90. Change in lower facial volume was quantified in cm^3 using image subtraction techniques; as the Baseline is an image, no Baseline data are reported. | Posted | Least Squares Mean | Full Range | cubic centimeter (cm^3) | Baseline (Day 1) to Day 90 of Treatment Cycle 1 |
|
Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
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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 | BOTOX® 96U | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis perforated | Infections and infestations | MedDRA, Version 20.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Facial paresis | Nervous system disorders | MedDRA, Version 20.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area, Head | Allergan | 714-246-4500 | clinicaltrials@allergan.com |
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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 | Feb 28, 2014 | Feb 26, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 12, 2018 | Feb 26, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| C563600 | Masticatory Muscles, Hypertrophy of |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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|
|
| Normal saline | Drug | Normal saline (placebo) administered intramuscularly to the bilateral masseter muscles. |
|
| Day 90 of Treatment Cycle 1 |
| Sydney |
| New South Wales |
| 2000 |
| Australia |
| Esteem Beauty & Day Spa | Main Beach | Queensland | 4217 | Australia |
| The Rose Medical & Aesthetic Centre | North Fremantle | Western Australia | 6159 | Australia |
| Dr. Jean Carruthers Cosmetic Surgery, Inc. | Vancouver | British Columbia | V5Z 4E1 | Canada |
| Dr. Shannon Humphrey Inc. | Vancouver | British Columbia | V5Z 4E1 | Canada |
| Project Skin MD | Vancouver | British Columbia | V6H 1K9 | Canada |
| Pacific Dermaesthetics | Vancouver | British Columbia | V6H 4E1 | Canada |
| Bertucci MedSpa | Woodbridge | Ontario | L4L 8E2 | Canada |
| Arthur Swift Research Inc. | Montreal | Quebec | H3Z 1B7 | Canada |
| Kaohsiung Medical University Hospital | Kaohsiung City | 80735 | Taiwan |
| National Taiwan University Hospital | Taipei | 10041 | Taiwan |
| Taipei Chang Gung Memorial Hospital of CGMF | Taipei | 10507 | Taiwan |
| Tri-Service General Hospital | Taipei | 11411 | Taiwan |
| Pregnancy |
|
| Lost to Follow-up |
|
| Personal Reasons |
|
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.
| BG002 | BOTOX® 48U | 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. |
| BG003 | BOTOX® 24U | 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. |
| BG004 | Placebo | Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable. |
| BG005 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| BOTOX® 96U |
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. |
| OG001 | BOTOX® 72U | 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. |
| OG002 | BOTOX® 48U | 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. |
| OG003 | BOTOX® 24U | 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. |
| OG004 | Placebo | Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable. |
|
|
|
| Secondary | 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. | Participants from the mITT population, all randomized participants who received at least 1 injection of study treatment and had at least 1 follow-up visit, with data available for analysis at Day 90. Missing data was imputed using last observation carried forward. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 90 of Treatment Cycle 1 |
|
|
|
|
| 0 |
| 38 |
| 1 |
| 38 |
| 13 |
| 38 |
| EG001 | BOTOX® 72U | 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. | 0 | 38 | 0 | 38 | 10 | 38 |
| EG002 | BOTOX® 48U | 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. | 0 | 37 | 0 | 37 | 12 | 37 |
| EG003 | BOTOX® 24U | 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. | 0 | 37 | 2 | 37 | 16 | 37 |
| EG004 | Placebo | Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable. | 0 | 37 | 3 | 37 | 10 | 37 |
| Peritonitis | Infections and infestations | MedDRA, Version 20.1 | Systematic Assessment |
|
| Kidney infection | Infections and infestations | MedDRA, Version 20.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA, Version 20.1 | Systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA, Version 20.1 | Systematic Assessment |
|
| Hepatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 20.1 | Systematic Assessment |
|
| Uterine leiomyomax | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 20.1 | Systematic Assessment | For this gender-specific preferred term, percentages were calculated based on gender-specific denominators for females. |
|
| Abortion induced | Surgical and medical procedures | MedDRA, Version 20.1 | Systematic Assessment | For this gender-specific preferred term, percentages were calculated based on gender-specific denominators for females. |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA, Version 20.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA, Version 20.1 | Systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Mastication disorder | Musculoskeletal and connective tissue disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA, Version 20.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA, Version 20.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA, Version 20.1 | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA, Version 20.1 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA, Version 20.1 | Systematic Assessment |
|
| Food allergy | Immune system disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| 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 |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
P-values for between-treatment comparisons were determined using CMH tests stratified by baseline MMPS. |
| < 0.001 |
| Percentage Difference |
| 48.2 |
| 2-Sided |
| 95 |
| 28.6 |
| 67.8 |
| Other |
| Cochran-Mantel-Haenszel | P-values for between-treatment comparisons were determined using CMH tests stratified by baseline MMPS. | < 0.001 | Percentage Difference | 54.3 | 2-Sided | 95 | 36.1 | 72.6 | Other |
| Cochran-Mantel-Haenszel | P-values for between-treatment comparisons were determined using CMH tests stratified by baseline MMPS. | <0.001 | Percentage Difference | 54.3 | 2-Sided | 95 | 36.1 | 72.6 | Other |