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The Efficacy of Incobotulinum Toxin A Injections for Treatment of Tinnitus: a Randomized Controlled Trial
Sponsor: University of Minnesota
Summary
Tinnitus is a persistent non-physiologic, non-psychiatric, ringing in the ear that affects up to 20% of the general US population. The purpose of this study is to assess the patient reported effectiveness of Xeomin (incobotulinumtoxinA) injections into the auricular muscles for relief of tinnitus with use of the Tinnitus Handicap Inventory questionnaire.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
41
Start Date
2023-01-01
Completion Date
2025-12-29
Last Updated
2026-10-27
Healthy Volunteers
No
Conditions
Interventions
incobotulinum toxin A
The study intervention is a syringe of 50 units of incobotulinum toxin A total, with 25 units per side, a total of 6 injection sites incobotulinum toxin A diluted into 1 ml of normal saline, injected in equal amounts into the anterior, superior, and posterior auricular muscles using anatomical landmarks. This will be approximately 0.16 mL (8-9 units) of the combined solution per injection site.
Placebo-Saline
Placebo injections will be preservative free normal saline. Injections will be administered similar to the drug injections.
Locations (1)
University of Minnesota
Minneapolis, Minnesota, United States