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DMSO Dual-Route Therapy for Tinnitus

(DART-TINN Trial)

SD
LE
Overseen ByLeading Edge Clinic Practice Manager
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Leading Edge Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

SD

Scott D Marsland, MS Nursing

Principal Investigator

Leading Edge Clinic

Are You a Good Fit for This Trial?

This trial is for adults aged 18–70 who have had bothersome, non-pulsing tinnitus for at least 6 months after long COVID or a COVID-19 vaccine injury. They must have tried at least two standard treatments without success and be able to attend an initial ENT visit and complete online follow-ups in English.

Inclusion Criteria

I have tried at least two treatments for tinnitus that did not work.
I have had constant ringing in my ears for at least 6 months.
Willing and able to provide informed consent.
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What Are the Treatments Tested in This Trial?

Interventions

  • DMSO Dual-Route Therapy

Trial Overview

The study tests a dual therapy using DMSO-based ear drops (with betahistine, dexamethasone, lidocaine) every 4 days and a DMSO-based cream (with levocarnitine, N-acetylcysteine) applied nightly around the ears/neck for 30 days. All participants receive both treatments.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: DMSO Dual-Route TherapyExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Leading Edge Clinic

Lead Sponsor

Rebuild Medicine Inc

Collaborator

Rebuild Medicine

Collaborator

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