Verification of the Efficacy/Safety of the Mixed Drug Injectable Delivery Vehicle for Treating Intractable Hearing Loss

May 20, 2026 updated by: Seoul National University Hospital

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dexamethasone+Saline+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).
Drug: Dexamethasone
Dexamethasone 5mg/ml
Other Names:
  • Dexamethasone Inj (Dexamethasone disodium phosphate 5㎎) [Daewon Pharm]
Other: Indocyanine green(ICG)
ICG 25mg
Other Names:
  • Cellbiongreen Inj (IndocyanineGreen 25mg) [Cellbion]
Experimental: Dexamethasone+Hyaluronic Acid+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).
Drug: Dexamethasone
Dexamethasone 5mg/ml
Other Names:
  • Dexamethasone Inj (Dexamethasone disodium phosphate 5㎎) [Daewon Pharm]
Drug: Hyaluronic acid
Hyaluronic Acid 20mg/2ml
Other Names:
  • Hyruan Plus Inj (Sodium Hyaluronate 10.0mg) [LG Chem]
Other: Indocyanine green(ICG)
ICG 25mg
Other Names:
  • Cellbiongreen Inj (IndocyanineGreen 25mg) [Cellbion]

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
0, 1day and 1 week after intratympanic injection
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)
0, 1day and 1 week after intratympanic injection
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)
0, 1day, 1 week and/or 1 month after intratympanic injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 15, 2026

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

September 30, 2028

Study Registration Dates

First Submitted

May 24, 2024

First Submitted That Met QC Criteria

May 24, 2024

First Posted (Actual)

May 31, 2024

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITV-2309-098-1469

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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