DMSO Dual-Route Therapy for Refractory Tinnitus in Long-COVID and Post-COVID-19 Vaccine Injury

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.

NCT Number	NCT07567274
Lead Sponsor	Leading Edge Clinic Collaborators: Rebuild Medicine Inc
Conditions	Tinnitus
Enrollment	20 participants
Start Date	2026-05-15
Primary Completion	2026-07 (estimated)
Study Completion	2027-05 (estimated)
Updated on ClinicalTrials.gov	2026-05-13