Hearing Loss, SensorineuralPhase 1/2NCT06437054
Verification of the Efficacy/Safety of the Mixed Drug Injectable Delivery Vehicle for Treating Intractable Hearing Loss
A Phase 1/2 study testing Dexamethasone, Hyaluronic acid and Indocyanine green(ICG) in people with Hearing Loss, Sensorineural and Hearing Loss, Sudden, run by Seoul National University Hospital.
Trial summary
This study is a prospective, randomized pilot study. To verify an efficacy/safety of the mixed drug injectable delivery vehicle for treating intractable hearing loss. Hearing test, endoscopy of tympanic membrane and CT scans will be conducted after intratympanic treatment for evaluation. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hearing Loss, Sensorineural, Hearing Loss, Sudden, Intratympanic Injection
- What is being tested?
- Dexamethasone, Hyaluronic acid and Indocyanine green(ICG)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2026to 30 Sep 2028
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with sudden hearing loss, Meniere's disease, ototoxic hearing loss, and noise-induced hearing loss of 25dB HL at the frequency at which hearing loss occurs as a result of pure tone hearing test
- Patients whose original hearing ability has not been restored with existing standard treatment (oral, intravenous steroids)
- Those who have not participated in clinical trials within 3 months are selected as subjects
Who cannot join
- Pregnant or lactating women
- When accompanied by lesion, infection, or anatomical deformity of the outer ear, middle ear, or inner ear
- Those with liver disease or metabolic disease or a history thereof
- History of hypersensitivity to indocyanine green or iodine hypersensitivity
- History of ear surgery
- Cases with posterior labyrinth lesions
- Patients with a history of hypersensitivity to the ingredients of this drug
- In addition, serious diseases such as end-stage renal disease, end-stage liver disease, cardiovascular surgery, progressive brain tumor, progressive hemorrhage, and progressive cerebral hemorrhage are included Cases with brain disease and cancer are excluded from the study
About this study
Official title: Verification of the Efficacy/Safety of the Mixed Drug Injectable Delivery Vehicle for Treating Intractable Hearing Loss (Pilot Study)
This study is a prospective, randomized pilot study. To verify an efficacy/safety of the mixed drug injectable delivery vehicle for treating intractable hearing loss. Hearing test, endoscopy of tympanic membrane and CT scans will be conducted after intratympanic treatment for evaluation.
Read the detailed description
The goal of this clinical trial (pilot study) is to evaluate the Efficacy and Safety of Combined Hyaluronic Acid and Dexamethasone Treatment in Patients with Hearing Loss. The main questions it aims to answer are: • Q1. Verification of safety, • Q2. Therapeutic effect of drug injection on sensorineural hearing loss. Participants will undergo several assessment tests (Verification of adverse effects in the external and middle ear through endoscopy, Confirmation of adverse effects through imaging, Hearing test to check for additional hearing loss, Check if subjective ear fullness persists for more than a week aside from the drug effect). If there is a comparison group: Researchers will compare dexamethasone and hyaluronic acid to verify hearing improvement and safety.
- Being tested
- Dexamethasone, Hyaluronic acid, Indocyanine green(ICG)
- Keywords
- drug delivery, Dexamethasone, Hyaluronic acid
- Medical subject headings
- Hearing Loss, Sensorineural, Hearing Loss, Sudden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Dexamethasone Inj (Dexamethasone disodium phosphate 5㎎) [Daewon Pharm]
Dexamethasone 5mg/ml
Hyaluronic acidDrug
Also called Hyruan Plus Inj (Sodium Hyaluronate 10.0mg) [LG Chem]
Hyaluronic Acid 20mg/2ml
Indocyanine green(ICG)Other
Also called Cellbiongreen Inj (IndocyanineGreen 25mg) [Cellbion]
ICG 25mg
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone+Saline+ICG | Active comparator | The experimental group received a single injection of Dexamethasone (5mg/ml) and Saline (D+Saline) mixed in a 1:1 ratio (with a possibility of a second injection if necessary). Additionally, two drops of Indocyanine Green (ICG: 25mg) were added, approximately 100μl (2.5mg/ml). Receives: Drug: Dexamethasone; Other: Indocyanine green(ICG) |
| Dexamethasone+Hyaluronic Acid+ICG | Experimental | The experimental group received a single injection of Dexamethasone (5mg/ml) and Hyaluronic acid (D+HA) mixed in a 1:1 ratio (with a possibility of a second injection if necessary). Additionally, two drops of Indocyanine Green (ICG: 25mg) were added, approximately 100μl (2.5mg/ml). Receives: Drug: Dexamethasone; Drug: Hyaluronic acid; Other: Indocyanine green(ICG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of Side Effect Rate through tympanic membrane endoscopy Imaging in 26 participants
Confirming healing time of perforation and inflammation (Safety)
Measured: 0, 1day and 1 week after intratympanic injection
Analysis of Drug Duration through CT Imaging in 26 participants
Checking a time duration of drug in middle and inner ear (Durability)
Measured: 0, 1day and 1 week after intratympanic injection
Comparison of Auditory Threshold Values Between Two Groups to Confirm Treatment Efficacy in 26 participants
Verifying therapeutic effect of intratympanic drug delivery vehicle (Efficacy)
Measured: 0, 1day, 1 week and/or 1 month after intratympanic injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start15 Dec 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion30 Sep 2028 (estimated)
Why it stopped: This study was withdrawn before enrollment due to challenges in participant recruitment. A revised study protocol will be initiated under a new research project.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, SensorineuralStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06437054
- Sponsor's protocol ID
- ITV-2309-098-1469
- Status last verified
- Apr 2026
- First submitted
- 24 May 2024
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verification of the Efficacy/Safety of the Mixed Drug Injectable Delivery Vehicle for Treating Intractable Hearing Loss (Pilot Study)
- ClinicalTrials.gov ID
- NCT06437054
- Acronym / sponsor ID
- ITV-2309-098-1469
- Keywords
- drug delivery, Dexamethasone, Hyaluronic acid
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was withdrawn before enrollment due to challenges in participant recruitment. A revised study protocol will be initiated under a new research project.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 15 Dec 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 31 May 2024 (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.
This study is a prospective, randomized pilot study. To verify an efficacy/safety of the mixed drug injectable delivery vehicle for treating intractable hearing loss. Hearing test, endoscopy of tympanic membrane and CT scans will be conducted after intratympanic treatment for evaluation.
Detailed description
The goal of this clinical trial (pilot study) is to evaluate the Efficacy and Safety of Combined Hyaluronic Acid and Dexamethasone Treatment in Patients with Hearing Loss. The main questions it aims to answer are: • Q1. Verification of safety, • Q2. Therapeutic effect of drug injection on sensorineural hearing loss. Participants will undergo several assessment tests (Verification of adverse effects in the external and middle ear through endoscopy, Confirmation of adverse effects through imaging, Hearing test to check for additional hearing loss, Check if subjective ear fullness persists for more than a week aside from the drug effect). If there is a comparison group: Researchers will compare dexamethasone and hyaluronic acid to verify hearing improvement and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone+Saline+ICG | Active comparator | Drug: Dexamethasone, Other: Indocyanine green(ICG)The experimental group received a single injection of Dexamethasone (5mg/ml) and Saline (D+Saline) mixed in a 1:1 ratio (with a possibility of a second injection if necessary). Additionally, two drops of Indocyanine Green (ICG: 25mg) were added, approximately 100μl (2.5mg/ml). |
| Dexamethasone+Hyaluronic Acid+ICG | Experimental | Drug: Dexamethasone, Drug: Hyaluronic acid, Other: Indocyanine green(ICG)The experimental group received a single injection of Dexamethasone (5mg/ml) and Hyaluronic acid (D+HA) mixed in a 1:1 ratio (with a possibility of a second injection if necessary). Additionally, two drops of Indocyanine Green (ICG: 25mg) were added, approximately 100μl (2.5mg/ml). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with sudden hearing loss, Meniere's disease, ototoxic hearing loss, and noise-induced hearing loss of 25dB HL at the frequency at which hearing loss occurs as a result of pure tone hearing test
- Patients whose original hearing ability has not been restored with existing standard treatment (oral, intravenous steroids)
- Those who have not participated in clinical trials within 3 months are selected as subjects
Key exclusion criteria (8 listed)
- Pregnant or lactating women
- When accompanied by lesion, infection, or anatomical deformity of the outer ear, middle ear, or inner ear
- Those with liver disease or metabolic disease or a history thereof
- History of hypersensitivity to indocyanine green or iodine hypersensitivity
- History of ear surgery
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 |
|---|---|---|
| DexamethasoneAlso: Dexamethasone Inj (Dexamethasone disodium phosphate 5㎎) [Daewon Pharm]Dexamethasone 5mg/ml | Drug | Dexamethasone+Hyaluronic Acid+ICG, Dexamethasone+Saline+ICG |
| Hyaluronic acidAlso: Hyruan Plus Inj (Sodium Hyaluronate 10.0mg) [LG Chem]Hyaluronic Acid 20mg/2ml | Drug | Dexamethasone+Hyaluronic Acid+ICG |
| Indocyanine green(ICG)Also: Cellbiongreen Inj (IndocyanineGreen 25mg) [Cellbion]ICG 25mg | Other | Dexamethasone+Hyaluronic Acid+ICG, Dexamethasone+Saline+ICG |
Primary outcome
Analysis of Side Effect Rate through tympanic membrane endoscopy Imaging in 26 participants
Time frame: 0, 1day and 1 week after intratympanic injection
Confirming healing time of perforation and inflammation (Safety)
Analysis of Drug Duration through CT Imaging in 26 participants
Time frame: 0, 1day and 1 week after intratympanic injection
Checking a time duration of drug in middle and inner ear (Durability)
Comparison of Auditory Threshold Values Between Two Groups to Confirm Treatment Efficacy in 26 participants
Time frame: 0, 1day, 1 week and/or 1 month after intratympanic injection
Verifying therapeutic effect of intratympanic drug delivery vehicle (Efficacy)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dexamethasone, Hyaluronic acid and Indocyanine green(ICG) in people with Hearing Loss, Sensorineural and Hearing Loss, Sudden, run by Seoul National University Hospital.
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 3 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: withdrawn, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Analysis of Side Effect Rate through tympanic membrane endoscopy Imaging in 26 participants (time frame: 0, 1day and 1 week after intratympanic injection). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2026.