Phase 4 N=71 Randomized Single-blind Treatment

Comparison of Three Botulinum Neuromodulators for Management of Facial Synkinesis

Facial Nerve Injuries · Facial Paresis Associated With Facial Nerve Dysfunction · Facial Asymmetry · Synkinesis

Bottom Line

View on ClinicalTrials.gov: NCT03048383 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2017

Primary outcome: Primary: Change in Synkinesis Assessment Questionnaire (SAQ) Scores — 45.9; 38.8; 51.3; 45.2 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: OnabotulinumtoxinA Injectable Product (Drug); AbobotulinumtoxinA Injectable Product (Drug); Incobotulinumtoxin A Injectable Product (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Utah
Primary completion: Mar 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Synkinesis Assessment Questionnaire (SAQ) Scores	45.9; 38.8; 51.3; 45.2; 37.6; 49.8	—
SECONDARY Adverse Events	0; 0; 0	—

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.

Eligibility Criteria

Inclusion Criteria

Facial synkinesis

Exclusion Criteria

Previous complication from botulinum toxin neuromodulator injection
Inability to understand or complete the SAQ survey
Inability to participate in follow-up
Pregnancy

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Data sourced from ClinicalTrials.gov (NCT03048383). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.