TinnitusPhase 2DART-TINNNCT07567274
DMSO Dual-Route Therapy for Refractory Tinnitus in Long-COVID and Post-COVID-19 Vaccine Injury
A Phase 2 study testing DMSO-based otic solution with betahistine, dexamethasone, and lidocaine and DMSO-based transdermal cream with levocarnitine and N-acetylcysteine in people with Tinnitus, run by Leading Edge Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- DMSO-based otic solution with betahistine, dexamethasone, and lidocaine and DMSO-based transdermal cream with levocarnitine and N-acetylcysteine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2026to May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 to 70 years of age.
- Chronic subjective non-pulsatile tinnitus for at least 6 months.
- Bothersome tinnitus defined by a Tinnitus Handicap Inventory (THI) score ≥ 20 at screening.
- Documented history of post-acute sequelae of SARS-CoV-2 (PASC, long COVID) or post-COVID-19 vaccine injury, with tinnitus onset or clear worsening temporally associated with that event.
- Failure of at least two prior tinnitus therapies (for example, sound therapy, counseling or cognitive-behavioral approaches, pharmacologic treatments, or steroid therapy).
- Willing and able to provide informed consent.
- Able to complete telemedicine visits and electronic questionnaires in English and to attend a baseline in-person otolaryngology (ENT) evaluation.
Who cannot join
- Objective or pulsatile tinnitus, or tinnitus primarily synchronous with the heartbeat.
- Active middle-ear infection, acute otitis media, tympanic membrane perforation, or current otorrhea.
- Recent exposure (within the past 3 months) to known ototoxic medications associated with new or rapidly worsening tinnitus.
- Known hypersensitivity or allergy to dimethyl sulfoxide (DMSO) or any component of the study formulations (betahistine, dexamethasone, lidocaine, levocarnitine, N-acetylcysteine, or excipients).
- Pregnancy or breastfeeding.
- Uncontrolled or severe psychiatric illness (for example, active psychosis, acute suicidality) that, in the opinion of the investigator, would interfere with participation or completion of questionnaires.
- Inability to comply with study procedures, including telemedicine visits, electronic data capture, or topical/otic dosing instructions.
- Any other otologic or neurologic condition judged by the investigator to confound tinnitus assessment or pose unacceptable risk with DMSO-based therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Nationwide Telemedicine Study (Leading Edge Clinic)
Ithaca, New York, 14851
About this study
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
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.
Read more
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.
Read the detailed description
Subjective non-pulsatile tinnitus is a common and often debilitating symptom in patients with post-acute sequelae of SARS-CoV-2 (PASC, long-COVID) and post-COVID-19 vaccine injury. Mechanisms are thought to include neuroinflammation, microvascular dysfunction, oxidative stress, and mitochondrial impairment within cochlear and central auditory pathways. A substantial proportion of patients remain highly symptomatic despite standard therapies such as sound therapy, cognitive behavioral approaches, antidepressants, and corticosteroids. No FDA-approved curative pharmacologic therapy exists for chronic subjective tinnitus.
Dimethyl sulfoxide (DMSO) is a tree-derived solvent with anti-inflammatory, antioxidant, vasodilatory, and penetration-enhancing properties. A foundational open-label study in the 1970s reported that DMSO-based formulations combined with vasoactive and anti-inflammatory agents improved or resolved subjective tinnitus in most treated patients, but this approach has not been systematically evaluated in modern refractory PASC or vaccine-injury cohorts. This pilot trial modernizes that historical concept using current compounding standards and telemedicine-enabled follow-up.
This is a prospective, single-arm, open-label pilot study of approximately 20 adults with refractory subjective tinnitus attributed to PASC or post-COVID-19 vaccine injury. All participants receive a dual-route regimen for 30 days: (1) a DMSO-based otic liquid instilled into the external auditory canal every 4 days, and (2) a DMSO-based transdermal cream applied once daily to the bilateral mastoid regions, periauricular skin, and upper posterior neck. Both formulations are compounded by a licensed pharmacy according to protocol specifications. Standard tinnitus counseling and sound therapy are allowed, but no new tinnitus-specific medications may be started during the 30-day treatment window.
The primary objective is to estimate the proportion of participants achieving at least a 50% reduction in Tinnitus Handicap Inventory (THI) score from baseline to Day 30. Secondary objectives include changes in THI score at later time points, visual analog scale (VAS) ratings of tinnitus loudness, annoyance, sleep interference, and concentration, patient global impression of change, and VAS measures of concomitant symptoms such as vertigo, insomnia, headache, and fatigue. Safety and tolerability are assessed by monitoring adverse events, including expected DMSO-related effects such as transient odor or skin irritation. Exploratory measures may include changes in tympanic membrane temperature and audiometric parameters where available.
Screening and informed consent are performed via telemedicine, followed by a required baseline in-person ENT evaluation with otoscopy, audiometry, and completion of the THI and other questionnaires. During the 30-day treatment period, participants have regular telemedicine check-ins and complete electronic questionnaires through a secure, HIPAA-compliant REDCap-based platform. Follow-up assessments occur at approximately 6 and 12 months to evaluate durability of tinnitus response and longer-term safety. As a pilot study, analyses are descriptive and use paired pre- and post-treatment comparisons to generate effect-size estimates and feasibility data for future controlled trials.
- Conditions
- Tinnitus
- Being tested
- DMSO-based otic solution with betahistine, dexamethasone, and lidocaine, DMSO-based transdermal cream with levocarnitine and N-acetylcysteine
- Keywords
- Chronic subjective tinnitus, Refractory tinnitus, Tinnitus, Long COVID, Post-acute sequelae of SARS-CoV-2 (PASC), Post-COVID-19 vaccine injury, COVID-19 vaccine-associated tinnitus, Dimethyl sulfoxide, DMSO, DMSO dual-route therapy, Otic DMSO, Transdermal DMSO, Compounded otic drops, Compounded transdermal cream, Tinnitus Handicap Inventory, THI, Telemedicine clinical trial, Indigenous medicine, Botanical medicine
- Medical subject headings
- Tinnitus, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DMSO-based otic solution with betahistine, dexamethasone, and lidocaineDrug
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-acetylcysteineDrug
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 group | Role | What they receive |
|---|---|---|
| DMSO Dual-Route Therapy | Experimental | 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. Receives: Drug: DMSO-based otic solution with betahistine, dexamethasone, and lidocaine; Drug: DMSO-based transdermal cream with levocarnitine and N-acetylcysteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with at least 50% reduction in Tinnitus Handicap Inventory (THI) score
The Tinnitus Handicap Inventory (THI) is a 25-item validated questionnaire (total score 0-100) that measures tinnitus-related handicap. Responders are defined as participants with a reduction of at least 50% in total THI score from baseline to Day 30.
Measured: Baseline to Day 30
Secondary outcomes (9)
Change in Tinnitus Handicap Inventory (THI) score over time
Change in total THI score from baseline to Day 30, Month 6, and Month 12. Higher scores indicate greater tinnitus-related handicap.
Measured: Baseline to Day 30, Month 6, and Month 12
Change in tinnitus loudness on visual analog scale (VAS)
Participants rate tinnitus loudness on a 0-10 visual analog scale (0 = no tinnitus, 10 = worst imaginable). Change is calculated as follow-up minus baseline at each time point.
Measured: Baseline to Day 30, Month 6, and Month 12
Change in tinnitus annoyance/distress on visual analog scale (VAS)
Participants rate how annoying or distressing their tinnitus is on a 0-10 visual analog scale (0 = not at all annoying, 10 = extremely annoying). Change is calculated as follow-up minus baseline.
Measured: Baseline to Day 30, Month 6, and Month 12
Change in sleep interference due to tinnitus on visual analog scale (VAS)
Participants rate how much tinnitus interferes with sleep on a 0-10 visual analog scale (0 = no interference, 10 = extreme interference). Change is calculated as follow-up minus baseline.
Measured: Baseline to Day 30, Month 6, and Month 12
Change in concentration difficulty due to tinnitus on visual analog scale (VAS)
Participants rate how much tinnitus interferes with concentration on a 0-10 visual analog scale (0 = no interference, 10 = extreme interference). Change is calculated as follow-up minus baseline.
Measured: Baseline to Day 30, Month 6, and Month 12
Patient Global Impression of Change (PGIC) in tinnitus symptoms
Participants rate overall change in their tinnitus on a 7-point Patient Global Impression of Change scale (1 = very much improved, 7 = very much worse). Outcomes will be summarized as the proportion reporting "much improved" or "very much improved" and as distribution across all categories.
Measured: Day 30, Month 6, and Month 12
Change in concomitant symptom scores (vertigo, insomnia, headache, fatigue) on visual analog scales (VAS)
Participants rate vertigo, insomnia, headache, and fatigue on separate 0-10 visual analog scales (0 = no symptom, 10 = worst imaginable). Change in each symptom score from baseline to Day 30 will be summarized descriptively.
Measured: Baseline to Day 30
Incidence of treatment-emergent adverse events
Number and proportion of participants experiencing treatment-emergent adverse events, including expected DMSO-related effects (e.g., garlic-like odor, transient warmth or flushing, skin irritation) and any serious or unexpected events. Events will be coded and summarized by severity and relationship to study treatment.
Measured: From first dose through Day 30
Change in tympanic membrane temperature
In participants with local ENT follow-up, tympanic membrane temperature is measured at baseline and Day 30. Change in temperature will be summarized descriptively as an exploratory biomarker of local vascular and inflammatory effects.
Measured: Baseline to Day 30 (where measured)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start15 May 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Intervention Model: Single Group Assignment. This is a prospective, single-arm trial in which all enrolled participants receive the same DMSO-based dual-route therapy (otic liquid plus transdermal cream) for 30 days, with no control or comparison group.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leading Edge Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Rebuild Medicine Inc
- Responsible party
- Sponsor
- Investigators
- Scott D Marsland, MS Nursing, Principal investigator, Leading Edge Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07567274
- Sponsor's protocol ID
- IMIRB-202600105
- Acronym
- DART-TINN
- Status last verified
- May 2026
- First submitted
- 1 May 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data (IPD) will be shared. Aggregate study results may be published in scientific journals and presented at conferences.
Publications
Newman CW, Jacobson GP, Spitzer JB. Development of the Tinnitus Handicap Inventory. Arch Otolaryngol Head Neck Surg. 1996 Feb;122(2):143-8. doi: 10.1001/archotol.1996.01890140029007.
PubMed 8630207Caro AZ. Dimethyl sulfoxide therapy in subjective tinnitus of unknown origin. Ann N Y Acad Sci. 1975 Jan 27;243:468-74. doi: 10.1111/j.1749-6632.1975.tb25389.x.
PubMed 1055561
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07567274
- Acronym / sponsor ID
- DART-TINN / IMIRB-202600105
- Conditions
- Tinnitus
- Keywords
- Chronic subjective tinnitus, Refractory tinnitus, Tinnitus, Long COVID, Post-acute sequelae of SARS-CoV-2 (PASC), Post-COVID-19 vaccine injury, COVID-19 vaccine-associated tinnitus, Dimethyl sulfoxide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Leading Edge ClinicUniversity, hospital or other
- Collaborators
- Rebuild Medicine Inc
- Study start
- 15 May 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Subjective non-pulsatile tinnitus is a common and often debilitating symptom in patients with post-acute sequelae of SARS-CoV-2 (PASC, long-COVID) and post-COVID-19 vaccine injury. Mechanisms are thought to include neuroinflammation, microvascular dysfunction, oxidative stress, and mitochondrial impairment within cochlear and central auditory pathways. A substantial proportion of patients remain highly symptomatic despite standard therapies such as sound therapy, cognitive behavioral approaches, antidepressants, and corticosteroids. No FDA-approved curative pharmacologic therapy exists for chronic subjective tinnitus.
Dimethyl sulfoxide (DMSO) is a tree-derived solvent with anti-inflammatory, antioxidant, vasodilatory, and penetration-enhancing properties. A foundational open-label study in the 1970s reported that DMSO-based formulations combined with vasoactive and anti-inflammatory agents improved or resolved subjective tinnitus in most treated patients, but this approach has not been systematically evaluated in modern refractory PASC or vaccine-injury cohorts. This pilot trial modernizes that historical concept using current compounding standards and telemedicine-enabled follow-up.
This is a prospective, single-arm, open-label pilot study of approximately 20 adults with refractory subjective tinnitus attributed to PASC or post-COVID-19 vaccine injury. All participants receive a dual-route regimen for 30 days: (1) a DMSO-based otic liquid instilled into the external auditory canal every 4 days, and (2) a DMSO-based transdermal cream applied once daily to the bilateral mastoid regions, periauricular skin, and upper posterior neck. Both formulations are compounded by a licensed pharmacy according to protocol specifications. Standard tinnitus counseling and sound therapy are allowed, but no new tinnitus-specific medications may be started during the 30-day treatment window.
The primary objective is to estimate the proportion of participants achieving at least a 50% reduction in Tinnitus Handicap Inventory (THI) score from baseline to Day 30. Secondary objectives include changes in THI score at later time points, visual analog scale (VAS) ratings of tinnitus loudness, annoyance, sleep interference, and concentration, patient global impression of change, and VAS measures of concomitant symptoms such as vertigo, insomnia, headache, and fatigue. Safety and tolerability are assessed by monitoring adverse events, including expected DMSO-related effects such as transient odor or skin irritation. Exploratory measures may include changes in tympanic membrane temperature and audiometric parameters where available.
Screening and informed consent are performed via telemedicine, followed by a required baseline in-person ENT evaluation with otoscopy, audiometry, and completion of the THI and other questionnaires. During the 30-day treatment period, participants have regular telemedicine check-ins and complete electronic questionnaires through a secure, HIPAA-compliant REDCap-based platform. Follow-up assessments occur at approximately 6 and 12 months to evaluate durability of tinnitus response and longer-term safety. As a pilot study, analyses are descriptive and use paired pre- and post-treatment comparisons to generate effect-size estimates and feasibility data for future controlled trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intervention Model: Single Group Assignment. This is a prospective, single-arm trial in which all enrolled participants receive the same DMSO-based dual-route therapy (otic liquid plus transdermal cream) for 30 days, with no control or comparison group.
| Arm | Type | Receives |
|---|---|---|
| DMSO Dual-Route Therapy | Experimental | Drug: DMSO-based otic solution with betahistine, dexamethasone, and lidocaine, Drug: DMSO-based transdermal cream with levocarnitine and N-acetylcysteineAll 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults 18 to 70 years of age.
- Chronic subjective non-pulsatile tinnitus for at least 6 months.
- Bothersome tinnitus defined by a Tinnitus Handicap Inventory (THI) score ≥ 20 at screening.
- Documented history of post-acute sequelae of SARS-CoV-2 (PASC, long COVID) or post-COVID-19 vaccine injury, with tinnitus onset or clear worsening temporally associated with that event.
- Failure of at least two prior tinnitus therapies (for example, sound therapy, counseling or cognitive-behavioral approaches, pharmacologic treatments, or steroid therapy).
Key exclusion criteria (8 listed)
- Objective or pulsatile tinnitus, or tinnitus primarily synchronous with the heartbeat.
- Active middle-ear infection, acute otitis media, tympanic membrane perforation, or current otorrhea.
- Recent exposure (within the past 3 months) to known ototoxic medications associated with new or rapidly worsening tinnitus.
- Known hypersensitivity or allergy to dimethyl sulfoxide (DMSO) or any component of the study formulations (betahistine, dexamethasone, lidocaine, levocarnitine, N-acetylcysteine, or excipients).
- Pregnancy or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DMSO-based otic solution with betahistine, dexamethasone, and lidocaineCompounded 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. | Drug | DMSO Dual-Route Therapy |
| DMSO-based transdermal cream with levocarnitine and N-acetylcysteineCompounded 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. | Drug | DMSO Dual-Route Therapy |
Primary outcome
Proportion of participants with at least 50% reduction in Tinnitus Handicap Inventory (THI) score
Time frame: Baseline to Day 30
The Tinnitus Handicap Inventory (THI) is a 25-item validated questionnaire (total score 0-100) that measures tinnitus-related handicap. Responders are defined as participants with a reduction of at least 50% in total THI score from baseline to Day 30.
9 secondary outcomes
Change in Tinnitus Handicap Inventory (THI) score over time
Time frame: Baseline to Day 30, Month 6, and Month 12
Change in tinnitus loudness on visual analog scale (VAS)
Time frame: Baseline to Day 30, Month 6, and Month 12
Change in tinnitus annoyance/distress on visual analog scale (VAS)
Time frame: Baseline to Day 30, Month 6, and Month 12
Change in sleep interference due to tinnitus on visual analog scale (VAS)
Time frame: Baseline to Day 30, Month 6, and Month 12
Change in concentration difficulty due to tinnitus on visual analog scale (VAS)
Time frame: Baseline to Day 30, Month 6, and Month 12
Patient Global Impression of Change (PGIC) in tinnitus symptoms
Time frame: Day 30, Month 6, and Month 12
Change in concomitant symptom scores (vertigo, insomnia, headache, fatigue) on visual analog scales (VAS)
Time frame: Baseline to Day 30
Incidence of treatment-emergent adverse events
Time frame: From first dose through Day 30
Change in tympanic membrane temperature
Time frame: Baseline to Day 30 (where measured)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Background: PubMed 8630207Newman CW, Jacobson GP, Spitzer JB. Development of the Tinnitus Handicap Inventory. Arch Otolaryngol Head Neck Surg. 1996 Feb;122(2):143-8. doi: 10.1001/archotol.1996.01890140029007.
- Background: PubMed 1055561Caro AZ. Dimethyl sulfoxide therapy in subjective tinnitus of unknown origin. Ann N Y Acad Sci. 1975 Jan 27;243:468-74. doi: 10.1111/j.1749-6632.1975.tb25389.x.
- Individual participant dataSharing planned: No. No individual participant data (IPD) will be shared. Aggregate study results may be published in scientific journals and presented at conferences.
Related trials for Tinnitus
Not yet recruitingPhase 1/2
Acute Nicotine Gum and Auditory Brain Responses in Adults With Chronic Tinnitus
Tinnitus, Chronic Subjective Tinnitus
RecruitingPhase 2
A Study of the Safety and Efficacy of TRTL-913 in Healthy Volunteers (Part A) and in Adults With Tinnitus (Part B)
Tinnitus
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
Enrolling by invitationObservational study
Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
Sensorineural Hearing Loss, Tinnitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Scott D Marsland, MS Nursing principal investigator
Leading Edge Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DMSO-based otic solution with betahistine, dexamethasone, and lidocaine and DMSO-based transdermal cream with levocarnitine and N-acetylcysteine in people with Tinnitus, run by Leading Edge Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with at least 50% reduction in Tinnitus Handicap Inventory (THI) score (time frame: Baseline to Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07567274, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.