Efficacy Study of Botulinum Toxin (BOTOX) Injections to Treat Vocal Fold Granulomas
Status:
Withdrawn
Trial end date:
2015-01-01
Target enrollment:
Participant gender:
Summary
Vocal process granulomas are inflammatory masses caused in part by vocal trauma that arise in
the posterior aspect of the vocal folds and result in throat pain, difficulty swallowing,
hoarseness, and globus sensation. Antireflux therapy treats most granulomas, but many are
recalcitrant to this therapy or take months to years to resolve. Botulinum toxin injection
into the thyroarytenoid muscle has been effectively employed for recalcitrant granuloma, but
causes significant voice loss, occasional difficulty swallowing and, in our clinical
experience, is associated with significant recurrence. The investigators propose injecting
another muscle in the larynx called the interarytenoid muscle with botulinum toxin type A to
maintain the benefit of injection with less loss of voice. The investigators have shown the
effectiveness of this treatment in a small, retrospective analysis.
Phase:
Phase 2
Details
Lead Sponsor:
Massachusetts Eye and Ear Infirmary Phillip Song, MD
Treatments:
abobotulinumtoxinA Botulinum Toxins Botulinum Toxins, Type A incobotulinumtoxinA Omeprazole onabotulinumtoxinA Proton Pump Inhibitors