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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/NCT02010775




Registration number
NCT02010775
Ethics application status
Date submitted
10/12/2013
Date registered
13/12/2013
Date last updated
28/05/2019

Titles & IDs
Public title
Botulinum Toxin Type A (BOTOX®) Treatment of Masseter Muscle Hypertrophy
Scientific title
BOTOX® Treatment of Masseter Muscle Hypertrophy
Secondary ID [1] 0 0
191622-130
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - botulinum toxin Type A
Treatment: Drugs - Normal saline

Active Comparator: 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.

Active Comparator: 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.

Active Comparator: 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.

Active Comparator: 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.

Placebo Comparator: Placebo - Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.


Other interventions: botulinum toxin Type A
Botulinum toxin Type A (BOTOX®) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.

Treatment: Drugs: Normal saline
Normal saline (placebo) administered intramuscularly to the bilateral masseter muscles.
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
Change From Baseline in Lower Facial Volume Using VECTRA 3D Images
Timepoint [1] 0 0
Baseline (Day 1) to Day 90 of Treatment Cycle 1
Secondary outcome [1] 0 0
Percentage of Participants Who Achieved a Masseter Muscle Prominence Scale (MMPS) Grade = 3 as Assessed by the Investigator
Timepoint [1] 0 0
Day 90 of Treatment Cycle 1

Eligibility
Key inclusion criteria
-Participants with Masseter Muscle Hypertrophy
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis,
or any other condition that might interfere with neuromuscular function

- Prior botulinum toxin treatment of any serotype to the masseter muscle or lower face

- History of dental or surgical procedure for lower facial shaping or masseter muscle
reduction

- History of or current temporomandibular joint disorder (TMJD)

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
20/01/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/11/2017
Sample size
Target
Accrual to date
Final
187
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 0 0
Shape Clinic - Darlinghurst
Recruitment hospital [2] 0 0
Central Sydney Dermatology - Sydney
Recruitment hospital [3] 0 0
Esteem Beauty & Day Spa - Main Beach
Recruitment hospital [4] 0 0
The Rose Medical & Aesthetic Centre - North Fremantle
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2000 - Sydney
Recruitment postcode(s) [3] 0 0
4217 - Main Beach
Recruitment postcode(s) [4] 0 0
6159 - North Fremantle
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
British Columbia
Country [2] 0 0
Canada
State/province [2] 0 0
Ontario
Country [3] 0 0
Canada
State/province [3] 0 0
Quebec
Country [4] 0 0
Taiwan
State/province [4] 0 0
Kaohsiung
Country [5] 0 0
Taiwan
State/province [5] 0 0
Taipei

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

Ethics approval
Ethics application status

Summary
Brief summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT02010775
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Beta Bowen
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02010775