At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 600 enrolled
Drug / intervention
Botulinum toxin type A +1 morebiological
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.
Phase III, Randomised, Double Blind, Placebo Controlled and Open Label Phase Multicentre Study to Investigate the Efficacy and Safety of BTX-A-HAC NG in the Treatment of Moderate to Severe Glabellar Lines, and Assess the Long Term Efficacy and Safety of BTX-A-HAC NG Following Repeated Treatments in This Indication
In Brief
A Phase 3 clinical trial evaluating Botulinum toxin type A and Placebo for Glabellar Lines. Completed, enrolled 600 participants across 24 sites in 3 countries.
Detailed Summary
The purpose of the protocol is to demonstrate the safety and the efficacy of a single injection of a new formulation of Clostridium Botulinum toxin type A haemagglutinin complex (BTX A HAC NG) to improve the appearance of moderate to severe glabellar lines (the lines between the eyebrows) and to assess the long term efficacy and safety of BTX-A-HAC NG after repeated injections.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlabellar Lines
CountriesFrance, Germany, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartApr 2015
First PostedJul 2015
Primary CompletionOct 2015
Study CompletionDec 2016
TodayJul 2026
First PostedJul 10, 2015
Enrollment StartApr 1, 2015
Primary CompletionOct 1, 2015
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 11.0 years ago
Interventions
Botulinum toxin type Abiological
Placebodrug