MT10109L Open label extension study for crow’s feet and/or frown lines
Research type
Research Study
Full title
A Multicenter, Long-term, Open-label Study to Evaluate the Safety of MT10109L (NivobotulinumtoxinA) for the Treatment of Glabellar Lines and Lateral Canthal Lines
IRAS ID
276505
Contact name
David Eccleston
Contact email
Sponsor organisation
Allergan Ltd.
Eudract number
2014-005303-24
Clinicaltrials.gov Identifier
121473, IND
Duration of Study in the UK
2 years, 4 months, 1 days
Research summary
Summary of Research
The purpose of this study is to look into the long-term safety of an investigational study drug called MT10109L, a botulinum toxin in liquid form, for the possible treatment of glabellar lines (frown lines) between the eyebrows, lateral canthal lines (crow’s feet lines) on the outer corner of the eyes, or both frown lines and crow’s feet lines when treated together.This study is an extension study of previous studies participants completed for the same investigational study drug. To qualify participants in the UK must have completed the lead-in phase III studies MT10109L-002 or MT10109L-005.
Within this study, participants will receive the same number of injections and in the same area(s) as they did in the previous study. However, unlike the previous study in which they may have received placebo (inactive study medication), they will only receive the active study drug (MT10109L) in this extension study.
Participants may receive up to 9 rounds of investigational study drug (MT10109L) in this study, in the frown lines and/or crow’s feet lines, based on meeting retreatment criteria.This research study is looking for approximately 800 participants from around the world (UK, US, Canada, Germany, Belgium and Russia).
REC name
East of Scotland Research Ethics Service REC 2
REC reference
20/ES/0049
Date of REC Opinion
5 Jun 2020
REC opinion
Further Information Favourable Opinion