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BOTOX® (onabotulinumtoxinA) Treatment of Masseter Muscle Prominence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03861936
Recruitment Status : Completed
First Posted : March 5, 2019
Results First Posted : April 28, 2021
Last Update Posted : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
Based on the results of the Phase 2 Study 191622-130 [NCT02010775], the current Phase 2b study is designed to further evaluate the safety and efficacy of BOTOX® for the treatment of Masseter Muscle Prominence (MMP) in adults.

Condition or disease Intervention/treatment Phase
Masseter Muscle Prominence Biological: OnabotulinumtoxinA Drug: Normal saline Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: BOTOX® (onabotulinumtoxinA) Treatment of Masseter Muscle Prominence: A Phase 2b, Multicenter, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study
Actual Study Start Date : May 16, 2019
Actual Primary Completion Date : April 3, 2020
Actual Study Completion Date : July 2, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Experimental: BOTOX® 72U
OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 72 units (U) total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
Biological: OnabotulinumtoxinA
OnabotulinumtoxinA (botulinum toxin Type A;BOTOX®) administered intramuscularly to the bilateral masseter muscles on Day 1.
Other Names:
  • BOTOX®
  • botulinum toxin Type A

Experimental: BOTOX® 48U
OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
Biological: OnabotulinumtoxinA
OnabotulinumtoxinA (botulinum toxin Type A;BOTOX®) administered intramuscularly to the bilateral masseter muscles on Day 1.
Other Names:
  • BOTOX®
  • botulinum toxin Type A

Placebo Comparator: Placebo
Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1.
Drug: Normal saline
Normal saline (placebo) administered intramuscularly to the bilateral masseter muscles on Day 1.




Primary Outcome Measures :
  1. Percentage of Participants Who Achieved Masseter Muscle Prominence Scale (MMPS) Grade ≤ 3 at Day 90 as Assessed by the Investigator [ Time Frame: Day 90 ]
    The investigator assessed the severity of the participant's masseter muscle prominence (MMP) using the MMPS 5-point scale where: 1=minimal (best), 2=mild, 3=moderate, 4=marked, and 5=very marked (worst). The percentage of participants where the investigator selected 1=minimal, 2=mild, or 3=moderate are reported.

  2. Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) [ Time Frame: First dose (Day 1) to the End of Study (Up to Day 180) ]
    An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. A TEAE is an AE that occurs or worsens after receiving study drug.

  3. Change From Baseline in Systolic Blood Pressure [ Time Frame: Baseline (Day 1) to the End of Study (Up to Day 180) ]
  4. Change From Baseline in Diastolic Blood Pressure [ Time Frame: Baseline (Day 1) to the End of Study (Up to Day 180) ]
  5. Change From Baseline in Respiratory Rate [ Time Frame: Baseline (Day 1) to the End of Study (Up to Day 180) ]
    Respiratory rate is calculated as number of breaths (inhalation and exhalation) in one minute.

  6. Change From Baseline in Pulse Rate [ Time Frame: Baseline (Day 1) to the End of Study (Up to Day 180) ] ]
    Pulse rate measures the number of times your heart beats per minute.


Secondary Outcome Measures :
  1. Percentage of Participants Who Achieved Participant Masseter Muscle Prominence Scale-Participant (MMPS-P) Grade ≤ 3 at Day 90 as Assessed by the Participant [ Time Frame: Day 90 ]
    The participant assessed the severity of their MMP using the MMPS-P 5-point scale where: 1=not at all pronounced (best), 2=mildly pronounced, 3=moderately pronounced, 4=pronounced, and 5=very pronounced (worst). The percentage of participants who selected 1=not at all pronounced, 2=mildly pronounced, or 3=moderately pronounced are reported.

  2. Percentage of Participants Who Achieved ≥ 2-grade MMPS Improvement From Baseline at Day 90 as Assessed by the Investigator [ Time Frame: Baseline (Day 1) to Day 90 ]
    The investigator assessed the severity of the participant's MMP using the MMPS 5-point scale where: 1=minimal (best), 2=mild, 3=moderate, 4=marked, and 5=very marked (worst). The percentage of participants who achieved a ≥ 2-grade improvement (decrease) from Baseline as assessed by the investigator are reported.

  3. Percentage of Participants Who Achieved ≥ 2-grade MMPS-P Improvement From Baseline at Day 90 as Assessed by the Participant [ Time Frame: Baseline (Day 1) to Day 90 ]
    The participant assessed the severity of their MMP using the MMPS-P 5-point scale where: 1=not at all pronounced (best), 2=mildly pronounced, 3=moderately pronounced, 4=pronounced, and 5=very pronounced (worst). The percentage of participants who achieved a ≥ 2-grade improvement (decrease) from Baseline as assessed by the participant are reported.

  4. Percentage of Participants Who Achieved Participant Self-Assessment of Change (PSAC) in MMP Grade ≥ 2 (at Least Moderately Improved From Baseline) at Day 90 [ Time Frame: Baseline (Day 1) to Day 90 ]
    The participants assessed the degree of change of their MMP using a single item composed of 7 grades (3 to -3) where: 3=much improved, 2=moderately improved, 1=minimally improved, 0=no change, -1=minimally worse, -2=moderately worse, and -3=much worse. The percentage of participants where the participant selected 2=moderately improved, or 3=much improved as compared to Baseline are reported.

  5. Change From Baseline in Lower Facial Volume at Day 90 Using Landmark Area of Interest (AOI) Analysis [ Time Frame: Baseline (Day 1) to Day 90 ]
    Lower facial volume was calculated from 3-dimensional (3D) surface images captured at Baseline and Day 90. The analysis region is defined using a series of anatomical landmarks placed on the baseline surface that are then projected mathematically to the posttreatment surface and verified by a technician. The difference in volume is measured between the select region of the baseline surface to the posttreatment surface. The lower facial volume is summed for both the left side and the right side of the face. An analysis of covariance (ANCOVA) model was used for analyses.

  6. Change From Baseline in Lower Facial Volume at Day 90 Using Statistical MMP AOI Analysis [ Time Frame: Baseline (Day 1) to Day 90 ]
    Lower facial volume was calculated from 3D surface models of the full area of the lower face captured at Baseline and Day 90. The statistical MMP AOI method is based on a statistical shape averaging of the area of change post masseter treatment from multiple facial models. The difference in volume is calculated between the two 3D surface models at Baseline and Day 90. An ANCOVA model was used for analyses.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • Participant has bilateral MMP (identical grades for left and right masseter), as determined at the Day 1 visit by the investigator using the MMPS
  • Participant has bilateral MMP, as determined at the Day 1 visit by the participant using the Masseter Muscle Prominence Scale-Participant (MMPS-P)
  • Body mass index (BMI) ≤ 30 kilogram/square meter (kg/m^2) using the calculation: BMI = weight (kg) [height (m^2)]
  • Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period. A female participant is eligible to participate if she is not pregnant (has a negative urine pregnancy result prior to randomization), not breastfeeding, and at least one of the following conditions applies:

    1. Not a woman of childbearing potential (WOCBP) OR
    2. A WOCBP who agrees to follow the contraceptive guidance during the treatment and follow-up period
  • Able, as assessed by the investigator, and willing to follow study instructions and likely to complete all required study visits.

Exclusion Criteria

  • 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
  • Any uncontrolled medical condition
  • 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 of entry into the study
  • Current or planned dental or facial procedures during the study period (eg, braces, dental implants, and reconstructive or aesthetic surgery) that could interfere with MMPS, as determined by the investigator
  • Facial hair or scarring (eg, acne) significant enough to interfere with the 3D clinical photography assessment
  • Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study
  • 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
  • Current intraoral infection, including infection of the mouth or gums, or facial skin infection requiring medical treatment in the opinion of the investigator
  • History of or current Temporomandibular Joint Dysfunction (TMJD), or presence of signs/symptoms of possible TMJD, in the opinion of the investigator
  • Weakness of the masseter, pterygoid, or temporalis muscles due to trauma, facial nerve injury, or other condition that could interfere with normal chewing and jaw clenching, as determined by the investigator
  • Excess lower facial fat, loose or lax skin in lower face, or parotid gland prominence that could interfere with MMPS, as determined by the investigator
  • Significant asymmetry of left and right sides of the face that could prevent identical MMPS grading on both sides of the face, as determined by the investigator
  • Masseter prominence due to other etiologies (eg, parotid gland infection, parotiditis, malignancy) based upon findings from the oral examination.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03861936


Locations
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United States, Alabama
Total Skin & Beauty Dermatology Center, PC
Birmingham, Alabama, United States, 35205
United States, California
Westside Aesthetics
Los Angeles, California, United States, 90025
Skin Care and Laser Physicians of Beverly Hills
Los Angeles, California, United States, 90069
Cosmetic Laser Dermatology
San Diego, California, United States, 92121
United States, Florida
Baumann Cosmetic and Research Institute
Miami, Florida, United States, 33137
United States, Illinois
DeNova Research
Chicago, Illinois, United States, 60611
United States, Louisiana
Etre, Cosmetic Dermatology and Laser Center
New Orleans, Louisiana, United States, 70130
United States, Missouri
Saint Louis University Dermatology
Saint Louis, Missouri, United States, 63122
United States, Nebraska
Skin Specialists, PC
Omaha, Nebraska, United States, 68144
United States, Tennessee
Nashville Centre for Laser and Facial Surgery
Nashville, Tennessee, United States, 37203
United States, Texas
DermResearch, Inc.
Austin, Texas, United States, 78759
Bellaire Dermatology Associates
Bellaire, Texas, United States, 77401
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, United States, 78660
United States, Utah
Advanced Clinical Research Gateway Aesthetic Institute & Laser Center
Salt Lake City, Utah, United States, 84101
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Tanya Brandstetter Allergan
  Study Documents (Full-Text)

Documents provided by Allergan:
Study Protocol  [PDF] February 12, 2019
Statistical Analysis Plan  [PDF] August 5, 2019

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03861936    
Other Study ID Numbers: 1789-202-008
First Posted: March 5, 2019    Key Record Dates
Results First Posted: April 28, 2021
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Allergan will share de-identified patient-level data and study-level data including protocols and clinical study reports for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. More information can be found on http://www.allerganclinicaltrials.com/.
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: After having received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published.
Access Criteria: To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.
URL: http://www.allerganclinicaltrials.com/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents