At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 121 enrolled
Drug / intervention
MT10109biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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®
In Brief
A Phase 2 clinical trial evaluating MT10109 for Glabellar Frown Lines. Completed, enrolled 121 participants across 1 site.
Detailed 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®
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlabellar Frown Lines
CountriesAustralia
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 2011
Enrollment StartDec 2011
Primary CompletionMar 2012
Study CompletionAug 2012
TodayJul 2026
First PostedDec 5, 2011
Enrollment StartDec 7, 2011
Primary CompletionMar 30, 2012
Study CompletionAug 17, 2012
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 14.6 years ago
Interventions
MT10109biological
Single dose intramuscular injection MT10109 vs Botox®