drugset / Trial / NCT03048383
Comparison of Three Botulinum Neuromodulators for Management of Facial Synkinesis
RandomizedParallel-groupSingle-blindTreatment
Summary
The purpose of this study is to compare the effectiveness of three commercially available botulinum toxin neuromodulators in the treatment of facial synkinesis using patient reported outcome measures.
Timeline
- Start
- 2012-07
- Primary completion
- 2015-03
- Completion
- 2015-03
Publications
- Background Choi KH, Rho SH, Lee JM, Jeon JH, Park SY, Kim J. Botulinum toxin injection of both sides of the face to treat post-paralytic facial synkinesis. J Plast Reconstr Aesthet Surg. 2013 Aug;66(8):1058-63. doi: 10.1016/j.bjps.2013.04.012. Epub 2013 May 15.
- Background Nettar KD, Yu KC, Bapna S, Boscardin J, Maas CS. An internally controlled, double-blind comparison of the efficacy of onabotulinumtoxinA and abobotulinumtoxinA. Arch Facial Plast Surg. 2011 Nov-Dec;13(6):380-6. doi: 10.1001/archfacial.2011.37. Epub 2011 Jun 20.
- Background Saad J, Gourdeau A. A direct comparison of onabotulinumtoxina (Botox) and IncobotulinumtoxinA (Xeomin) in the treatment of benign essential blepharospasm: a split-face technique. J Neuroophthalmol. 2014 Sep;34(3):233-6. doi: 10.1097/WNO.0000000000000110.
- Background Mehta RP, WernickRobinson M, Hadlock TA. Validation of the Synkinesis Assessment Questionnaire. Laryngoscope. 2007 May;117(5):923-6. doi: 10.1097/MLG.0b013e3180412460.
- Background Filipo R, Spahiu I, Covelli E, Nicastri M, Bertoli GA. Botulinum toxin in the treatment of facial synkinesis and hyperkinesis. Laryngoscope. 2012 Feb;122(2):266-70. doi: 10.1002/lary.22404. Epub 2012 Jan 17.
- Background Armstrong MW, Mountain RE, Murray JA. Treatment of facial synkinesis and facial asymmetry with botulinum toxin type A following facial nerve palsy. Clin Otolaryngol Allied Sci. 1996 Feb;21(1):15-20. doi: 10.1111/j.1365-2273.1996.tb01018.x.
- Background Naumann M, Albanese A, Heinen F, Molenaers G, Relja M. Safety and efficacy of botulinum toxin type A following long-term use. Eur J Neurol. 2006 Dec;13 Suppl 4:35-40. doi: 10.1111/j.1468-1331.2006.01652.x.
- Thomas AJ, Larson MO, Braden S, Cannon RB, Ward PD. Effect of 3 Commercially Available Botulinum Toxin Neuromodulators on Facial Synkinesis: A Randomized Clinical Trial. JAMA Facial Plast Surg. 2018 Mar 1;20(2):141-147. doi: 10.1001/jamafacial.2017.1393.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Botulinum toxin type A | Protein / enzyme biologic | — | Other |