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

Part of paid clinical trials in Ithaca, New York.

Sponsor
Leading Edge Clinic
Study ID
NCT07567274
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

  • Tinnitus

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • DMSO-based otic solution with betahistine, dexamethasone, and lidocaine — DRUG
    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 — DRUG
    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.

Study Details

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.

Key Dates

Start date
May 15, 2026
Status verified
May 2026
Primary completion
Jul 31, 2026
Completion
May 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: DMSO Dual-Route Therapy
    All participants receive compounded DMSO-based dual-route therapy consisting of a DMSO-based otic liquid applied to the external auditory canal every 4 days and a DMSO-based transdermal cream applied once daily to the mastoid and periauricular regions and upper posterior neck for 30 days.

Primary Outcome Measure

Proportion of participants with at least 50% reduction in Tinnitus Handicap Inventory (THI) score [ Time Frame: Baseline to Day 30 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Nationwide Telemedicine Study (Leading Edge Clinic)IthacaNew York14851-

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