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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT01485601
Ethics application status
Date submitted
1/12/2011
Date registered
5/12/2011
Date last updated
22/02/2024

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
Treatment: Other - MT10109

Experimental: MT10109 - Clostridium botulinum toxin type A

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


Treatment: Other: MT10109
Single dose intramuscular injection MT10109 vs Botox®
Intervention code [1] 0 0
Treatment: Other
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
Sex
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
7/12/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/08/2012
Sample size
Target
Accrual to date
Final
121
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/study/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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01485601