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The masseter muscle is one of the muscles in the lower face used for chewing. The prominence of the masseter muscle can appear as a widened lower face which some individuals deem as aesthetically undesirable and can be treated by selectively weakening the masseter muscles with small quantities of botulinum toxin. The purpose of this study is to assess how safe and effective injection of onabotulinumtoxinA (BOTOX) is in adult participants with Masseter Muscle Prominence (MMP).
BOTOX is being investigated for the treatment of Muscle Masseter Prominence. In Period 1, participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment, placebo or BOTOX. There is a 1 in 4 chance that participants will be assigned to placebo. In Period 2, eligible participants can receive an optional open-label retreatment of BOTOX. Approximately 200 adult participants with MMP will be enrolled in the study at approximately 20 sites in the United States.
Participants will receive intramuscular injections across both the right and left masseter muscle of either BOTOX or placebo on Day 1. Participants who are eligible for re-treatment will be given BOTOX injections on either the Day 180, 210, 240, or 270 visit and will be followed up for up to 6 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular monthly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects, and completing questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Double-Blind Period: BOTOX | Experimental | Participants will receive BOTOX injections across both the right and left masseter muscle on Day 1. |
|
| Double-Blind Period: Placebo | Placebo Comparator | Participants will receive placebo injections across both the right and left masseter muscle on Day 1. |
|
| Open-Label Period: BOTOX | Experimental | Participants who are eligible for re-treatment will receive BOTOX injections on either the Day 180, 210, 240, or 270 visit and will be followed for up to 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BOTOX | Drug | Intramuscular Injections |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite Achievement of MMP Severity Improvement and at Least a 2-Grade Improvement from Baseline by Both Investigator-Rated MMPS and Participant-Rated MMPS-P | The investigator and participant each assessed the participant's Masseter Muscle Prominence (MMP) using the Masseter Muscle Prominence Scale (MMPS) and the Masseter Muscle Prominence Scale-Participant (MMPS-P), respectively. Both are a 5-point masseter muscle severity scale with grades ranging from 1 (minimal/not at all noticeable) to 5 (very marked/extremely noticeable). | Day 90 |
| Number of Participants with Adverse Events (AEs) | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. | Baseline to Day 360 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants who Responded as "Very satisfied" or "Satisfied" on the Lower Facial Shape Questionnaire - Treatment Satisfaction Assessment (LFSQ-TXSAT) | The LFSQ-TXSAT measures satisfaction with the effect of treatment using a 5-point scale ranging from 'Very satisfied' to 'Very dissatisfied.' | Day 90 |
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Inclusion Criteria:
Participant meets the following criteria:
Body mass index (BMI) ≤ 30 kg/m^2 using the calculation: BMI = weight (kg)/height (m)^2.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Total Skin and Beauty Dermatology Center /ID# 248218 | Birmingham | Alabama | 35205 | United States | ||
| Mayo Clinic Arizona /ID# 248883 |
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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| Placebo | Drug | Intramuscular Injections |
|
| Percentage of Participants who Responded as "Not at all bothered" or "A little bothered" on the Bother Impact Assessment for Masseter Muscle Prominence (BIA-MMP) |
The BIA-MMP is a single item evaluation of how bothered the participant is by the appearance of their lower face using a 5-point scale from 'Not at all bothered' to 'Extremely bothered.' |
| Day 90 |
| Change from Baseline in Lower Facial Shape Questionnaire-Impact Assessment (LFSQ-IA) Summary Score | The LFSQ-IA measures psychosocial impact due to the appearance of the lower face. The LFSQ-IA summary score ranges from '0 (best)' to '24 (worst).' | Baseline to Day 90 |
| Percentage of Participants Achieving Investigator-Rated MMPS Improvement Over Time | The investigator assessed the participant's MMP using the MMPS, a 5-point masseter muscle severity scale with grades ranging from 1 (minimal) to 5 (very marked). | Baseline to Day 360 |
| Percentage of Participants Achieving Participant-Rated MMPS-P Improvement Over Time | The investigator assessed the participant's MMP using the MMPS-P, a 5-point masseter muscle severity scale with grades ranging from 1 (not at all noticeable) to 5 (extremely noticeable). | Baseline to Day 360 |
| Phoenix |
| Arizona |
| 85054 |
| United States |
| Skin Care and Laser Physicians of Beverly Hills /ID# 248223 | Los Angeles | California | 90069 | United States |
| Cosmetic Laser Dermatology /ID# 248215 | San Diego | California | 92121-2119 | United States |
| Ava T. Shamban MD - Santa Monica. /ID# 248886 | Santa Monica | California | 90404-2208 | United States |
| DMR Research PLLC /ID# 248485 | Westport | Connecticut | 06880 | United States |
| Susan H. Weinkle MD /ID# 252063 | Bradenton | Florida | 34209-5642 | United States |
| Skin and Cancer Associates, LLP /ID# 248209 | Miami | Florida | 33137-3254 | United States |
| Coleman Center For Cosmetic Dermatologic Surgery /ID# 249827 | Metairie | Louisiana | 70006 | United States |
| Delricht Research /ID# 249825 | New Orleans | Louisiana | 70115 | United States |
| Clarkston Dermatology /ID# 248888 | Clarkston | Michigan | 48346 | United States |
| Skin Laser and Surgery Specialists of NY and NJ /ID# 251501 | Hackensack | New Jersey | 07601-1997 | United States |
| Edwin F. Williams III, MD FACS of LATHAM P.C. D/B/A THE REJUVA CENTER /ID# 248887 | Latham | New York | 12110 | United States |
| Wilmington Dermatology Center /ID# 250651 | Wilmington | North Carolina | 28403 | United States |
| Centricity Research Dublin Multispecialty /ID# 248484 | Dublin | Ohio | 43016 | United States |
| Tennessee Clinical Research Center /ID# 248486 | Nashville | Tennessee | 37215-2885 | United States |
| Bellaire Dermatology Associates /ID# 248221 | Bellaire | Texas | 77401 | United States |
| Dallas Plastic Surgery Institute /ID# 248220 | Dallas | Texas | 75231 | United States |
| Austin Institute for Clinical Research - Pflugerville /ID# 248217 | Pflugerville | Texas | 78660 | United States |
| SkinDC /ID# 248885 | Arlington | Virginia | 22209 | United States |
| 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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