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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03861936
Registration number
NCT03861936
Ethics application status
Date submitted
25/02/2019
Date registered
5/03/2019
Date last updated
28/04/2021
Titles & IDs
Public title
BOTOX® (onabotulinumtoxinA) Treatment of Masseter Muscle Prominence
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Scientific title
BOTOX® (onabotulinumtoxinA) Treatment of Masseter Muscle Prominence: A Phase 2b, Multicenter, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study
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Secondary ID [1]
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1789-202-008
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Masseter Muscle Prominence
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - OnabotulinumtoxinA
Treatment: Drugs - Normal saline
Experimental: BOTOX® 72U - OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 72 units (U) total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
Experimental: BOTOX® 48U - OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
Placebo Comparator: Placebo - Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1.
Other interventions: OnabotulinumtoxinA
OnabotulinumtoxinA (botulinum toxin Type A;BOTOX®) administered intramuscularly to the bilateral masseter muscles on Day 1.
Treatment: Drugs: Normal saline
Normal saline (placebo) administered intramuscularly to the bilateral masseter muscles on Day 1.
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Who Achieved Masseter Muscle Prominence Scale (MMPS) Grade = 3 at Day 90 as Assessed by the Investigator
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Assessment method [1]
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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.
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Timepoint [1]
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Day 90
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Primary outcome [2]
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Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
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Assessment method [2]
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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.
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Timepoint [2]
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First dose (Day 1) to the End of Study (Up to Day 180)
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Primary outcome [3]
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Change From Baseline in Systolic Blood Pressure
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Assessment method [3]
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Timepoint [3]
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Baseline (Day 1) to the End of Study (Up to Day 180)
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Primary outcome [4]
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Change From Baseline in Diastolic Blood Pressure
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Assessment method [4]
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Timepoint [4]
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Baseline (Day 1) to the End of Study (Up to Day 180)
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Primary outcome [5]
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Change From Baseline in Respiratory Rate
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Assessment method [5]
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Respiratory rate is calculated as number of breaths (inhalation and exhalation) in one minute.
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Timepoint [5]
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Baseline (Day 1) to the End of Study (Up to Day 180)
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Primary outcome [6]
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Change From Baseline in Pulse Rate
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Assessment method [6]
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Pulse rate measures the number of times your heart beats per minute.
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Timepoint [6]
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Baseline (Day 1) to the End of Study (Up to Day 180) ]
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Secondary outcome [1]
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Percentage of Participants Who Achieved Participant Masseter Muscle Prominence Scale-Participant (MMPS-P) Grade = 3 at Day 90 as Assessed by the Participant
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Assessment method [1]
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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.
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Timepoint [1]
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Day 90
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Secondary outcome [2]
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Percentage of Participants Who Achieved = 2-grade MMPS Improvement From Baseline at Day 90 as Assessed by the Investigator
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline (Day 1) to Day 90
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Secondary outcome [3]
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Percentage of Participants Who Achieved = 2-grade MMPS-P Improvement From Baseline at Day 90 as Assessed by the Participant
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline (Day 1) to Day 90
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Secondary outcome [4]
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Percentage of Participants Who Achieved Participant Self-Assessment of Change (PSAC) in MMP Grade = 2 (at Least Moderately Improved From Baseline) at Day 90
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline (Day 1) to Day 90
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Secondary outcome [5]
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Change From Baseline in Lower Facial Volume at Day 90 Using Landmark Area of Interest (AOI) Analysis
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline (Day 1) to Day 90
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Secondary outcome [6]
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Change From Baseline in Lower Facial Volume at Day 90 Using Statistical MMP AOI Analysis
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline (Day 1) to Day 90
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Eligibility
Key inclusion 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/05/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
2/07/2020
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Sample size
Target
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Accrual to date
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Final
150
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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Country [2]
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United States of America
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State/province [2]
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California
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United States of America
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Florida
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United States of America
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Illinois
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United States of America
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State/province [5]
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Louisiana
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United States of America
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State/province [6]
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Missouri
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United States of America
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Nebraska
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Utah
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Allergan
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03861936
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Tanya Brandstetter
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Address
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Allergan
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03861936
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