MT10109L in the Treatment of crow’s feet lines
Research type
Research Study
Full title
A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of MT10109L (NivobotulinumtoxinA) for the Treatment of Lateral Canthal Lines
IRAS ID
260892
Contact name
David Eccleston
Contact email
Sponsor organisation
Allergan Ltd.
Eudract number
2014-005279-10
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 7 months, 22 days
Research summary
The purpose of this study is to look into the safety and efficacy of an investigational study medication called MT10109L, a botulinum toxin in liquid form, in the possible treatment of lateral canthal lines (also called crow’s feet lines) at the outer corner of the eyes.
MT10109L is not yet approved for treatment of either frown lines or crow’s feet lines in North America, Europe, or other regions, which is why it is being further researched in this study.
In addition, this study will compare MT10109L with a placebo to see if MT10109L is better than a placebo. The placebo is a medically inactive substance that looks like the study medication, but does not contain any active ingredient.
The study is looking for approximately 225 participants globally with crow’s feet lines with 64 participants being recruited in the UK.
The study is split into 2 parts and if the participant qualifies to take part their participation will be for both parts. Both part 1 and part 2 will last approximately 6 months each.REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
19/WM/0194
Date of REC Opinion
24 Sep 2019
REC opinion
Further Information Favourable Opinion