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DMSO Dual-Route Therapy for Refractory Tinnitus in Long-COVID and Post-COVID-19 Vaccine Injury
Sponsor: Leading Edge Clinic
Summary
The goal of this clinical trial is to test a compounded dimethyl sulfoxide (DMSO)-based dual-route therapy for adults with refractory subjective tinnitus linked to long-COVID (post-acute sequelae of SARS-CoV-2) or post-COVID-19 vaccine injury. Participants have bothersome tinnitus that has not improved with at least two prior standard treatments. All participants will receive two study treatments for 30 days: a DMSO-based ear canal liquid and a DMSO-based transdermal cream applied to the skin around the ears and upper neck. The ear drops are used every 4 days, and the cream is applied once daily at bedtime. Both formulations are prepared by a licensed compounding pharmacy. The main question is whether at least half of the participants achieve a 50% or greater reduction in their Tinnitus Handicap Inventory (THI) score from baseline to Day 30. Researchers will also look at changes in tinnitus loudness and annoyance, sleep and concentration, other symptoms such as vertigo, insomnia, headache, and fatigue, and any side effects. After an initial in-person ear, nose, and throat (ENT) evaluation, all study visits are conducted by telemedicine. Participants complete electronic questionnaires through a secure, HIPAA-compliant system over 12 months of follow-up.
Official title: Single-Arm Pilot Study of Compounded DMSO-Based Dual-Route Therapy for Refractory Subjective Tinnitus in PASC and Post-COVID-19 Vaccine Injury
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-05-15
Completion Date
2027-05
Last Updated
2026-05-13
Healthy Volunteers
No
Conditions
Interventions
DMSO-based otic solution with betahistine, dexamethasone, and lidocaine
Compounded otic liquid containing dimethyl sulfoxide (DMSO) 50% (v/v), betahistine dihydrochloride 8 mg/mL, dexamethasone sodium phosphate 0.2 mg/mL, and lidocaine hydrochloride 1%. Instill 2 mL into the external auditory canal of the affected ear(s) every 4 days (total of 8 applications over 30 days). Formulation is prepared by a licensed compounding pharmacy according to protocol specifications.
DMSO-based transdermal cream with levocarnitine and N-acetylcysteine
Compounded transdermal cream containing dimethyl sulfoxide (DMSO) 60% (w/w), levocarnitine 10% (w/w), and N-acetylcysteine 10% (w/w). Apply approximately 1.5 mL (pea- to quarter-sized amount) once daily at bedtime to the bilateral mastoid regions, periauricular skin, and upper posterior neck, with occlusion for 60 minutes or overnight, then wash off in the morning. Formulation is prepared by a licensed compounding pharmacy according to protocol specifications.
Locations (1)
Nationwide Telemedicine Study (Leading Edge Clinic)
Ithaca, New York, United States