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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
Scientific title
BOTOX® (onabotulinumtoxinA) Treatment of Masseter Muscle Prominence: A Phase 2b, Multicenter, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study
Secondary ID [1] 0 0
1789-202-008
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Masseter Muscle Prominence 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Achieved Masseter Muscle Prominence Scale (MMPS) Grade = 3 at Day 90 as Assessed by the Investigator
Timepoint [1] 0 0
Day 90
Primary outcome [2] 0 0
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
Timepoint [2] 0 0
First dose (Day 1) to the End of Study (Up to Day 180)
Primary outcome [3] 0 0
Change From Baseline in Systolic Blood Pressure
Timepoint [3] 0 0
Baseline (Day 1) to the End of Study (Up to Day 180)
Primary outcome [4] 0 0
Change From Baseline in Diastolic Blood Pressure
Timepoint [4] 0 0
Baseline (Day 1) to the End of Study (Up to Day 180)
Primary outcome [5] 0 0
Change From Baseline in Respiratory Rate
Timepoint [5] 0 0
Baseline (Day 1) to the End of Study (Up to Day 180)
Primary outcome [6] 0 0
Change From Baseline in Pulse Rate
Timepoint [6] 0 0
Baseline (Day 1) to the End of Study (Up to Day 180) ]
Secondary outcome [1] 0 0
Percentage of Participants Who Achieved Participant Masseter Muscle Prominence Scale-Participant (MMPS-P) Grade = 3 at Day 90 as Assessed by the Participant
Timepoint [1] 0 0
Day 90
Secondary outcome [2] 0 0
Percentage of Participants Who Achieved = 2-grade MMPS Improvement From Baseline at Day 90 as Assessed by the Investigator
Timepoint [2] 0 0
Baseline (Day 1) to Day 90
Secondary outcome [3] 0 0
Percentage of Participants Who Achieved = 2-grade MMPS-P Improvement From Baseline at Day 90 as Assessed by the Participant
Timepoint [3] 0 0
Baseline (Day 1) to Day 90
Secondary outcome [4] 0 0
Percentage of Participants Who Achieved Participant Self-Assessment of Change (PSAC) in MMP Grade = 2 (at Least Moderately Improved From Baseline) at Day 90
Timepoint [4] 0 0
Baseline (Day 1) to Day 90
Secondary outcome [5] 0 0
Change From Baseline in Lower Facial Volume at Day 90 Using Landmark Area of Interest (AOI) Analysis
Timepoint [5] 0 0
Baseline (Day 1) to Day 90
Secondary outcome [6] 0 0
Change From Baseline in Lower Facial Volume at Day 90 Using Statistical MMP AOI Analysis
Timepoint [6] 0 0
Baseline (Day 1) to Day 90

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/05/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/07/2020
Sample size
Target
Accrual to date
Final
150
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
Nebraska
Country [8] 0 0
United States of America
State/province [8] 0 0
Tennessee
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Utah

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Allergan
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03861936
Trial related presentations / publications
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

Contacts
Principal investigator
Name 0 0
Tanya Brandstetter
Address 0 0
Allergan
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries