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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Treatment: Other - 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.


Treatment: Other: 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
Treatment: Other
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
Assessment method [1] 0 0
Lower facial volume was calculated from 3-dimensional (3D) images captured with the VECTRA M3 3D Stereophotogrammetry imaging system and was analyzed using computer assisted systems and predetermined facial landmarks. The difference in volume was measured between the select region of the baseline surface 3D model and the select region of the posttreatment surface 3D model. A negative change from Baseline (decrease in volume) indicates improvement.
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
Assessment method [1] 0 0
The investigator used visual inspection and palpation to grade the prominence of the participant's masseter muscle on the left and right sides of the face using the MMPS where: 1=minimal prominence (best), 2=mild prominence, 3=moderate prominence, 4=marked prominence, 5=very marked prominence (worst). The percentage of participants with grade 3 or less is reported.
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
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Beta Bowen
Address 0 0
Allergan
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02010775