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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01485601




Registration number
NCT01485601
Ethics application status
Date submitted
1/12/2011
Date registered
5/12/2011
Date last updated
20/09/2012

Titles & IDs
Public title
Safety and Efficacy Study of Botulinum Toxin Type A to Treat Glabellar Lines
Scientific title
A Randomised, Double-blind, Multi-centre, Phase II, Optimal Dose-finding Study to Determine the Safety and Efficacy of MT10109 (Clostridium Botulinum Toxin Type A) in Subjects With Moderate to Severe Glabellar Lines in Comparison to BOTOX®
Secondary ID [1] 0 0
MT-GPRT-GL01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glabellar Frown Lines 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - MT10109

Experimental: MT10109 - Clostridium botulinum toxin type A

Active Comparator: Botox (registered trade mark) - Clostridium botulinum toxin type A


Other interventions: MT10109
Single dose intramuscular injection MT10109 vs Botox®

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Investigator's rating of glabellar line severity at maximum frown by live assessment.
Timepoint [1] 0 0
at Day 30

Eligibility
Key inclusion criteria
- Adults aged between 18 and 75 years with glabellar facial lines of at least moderate
severity at maximum frown by investigator's assessment.

- Women of childbearing potential must have a negative serum pregnancy test at screening
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients with an inability to substantially lessen glabellar lines by physically
spreading them apart.

- Concurrent therapy that, in the investigator's opinion, would interfere with the
evaluation of the safety or efficacy of the study medication

- Patients with an anaphylactic response history to botulinum toxin type A.

- Patients who have been administered botulinum toxin type A within the previous 6
months.

- Pregnant or lactating women.

- Participation in any research study involving drug administration within 90 days
preceding enrollment.

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 administering the treatment/s
The people assessing the outcomes
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Medy-Tox
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to find an optimal dose to determine the safety and tolerability
of a single dose of MT10109(clostridium botulinum type A) administered by intramuscular
injection in subjects with glabellar lines compared with the standard dose of BOTOX®
Trial website
https://clinicaltrials.gov/show/NCT01485601
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Peter Foley, Doctor
Address 0 0
Austrailia
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
Other publications