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

NCT06437054 | Not Yet Recruiting Phase 1

• 1 other identifier: ITV-2309-098-1469
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hearing Loss, Sensorineural; Hearing Loss, Sudden; Intratympanic Injection

Keywords

drug delivery; Dexamethasone; Hyaluronic acid

Outcome Measures

Primary Outcomes (3)

• Analysis of Side Effect Rate through tympanic membrane endoscopy Imaging in 26 participants

  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

  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

  Verifying therapeutic effect of intratympanic drug delivery vehicle (Efficacy)

  0, 1day, 1 week and/or 1 month after intratympanic injection

Study Arms (2)

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).

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).

Drug: Dexamethasone; Drug: Hyaluronic acid; Other: Indocyanine green(ICG)

Interventions

Hyaluronic acid DRUG

Hyaluronic Acid 20mg/2ml

Also known as: Hyruan Plus Inj (Sodium Hyaluronate 10.0mg) [LG Chem]

Dexamethasone+Hyaluronic Acid+ICG

Indocyanine green(ICG) OTHER

ICG 25mg

Also known as: Cellbiongreen Inj (IndocyanineGreen 25mg) [Cellbion]

Dexamethasone+Hyaluronic Acid+ICG; Dexamethasone+Saline+ICG

Dexamethasone DRUG

Dexamethasone 5mg/ml

Also known as: Dexamethasone Inj (Dexamethasone disodium phosphate 5㎎) [Daewon Pharm]

Dexamethasone+Hyaluronic Acid+ICG; Dexamethasone+Saline+ICG

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

MeSH Terms

Conditions

Hearing Loss, Sensorineural; Hearing Loss, Sudden

Interventions

Dexamethasone; Hyaluronic Acid; Indocyanine Green

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Glycosaminoglycans; Polysaccharides; Carbohydrates; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Myung-Whan Suh

CONTACT

+821039490330; drmung@naver.com

Yu-Jung HWANG

CONTACT

eliteyujung@naver.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: May 31, 2024
• Study Start (Estimated): December 15, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): September 30, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share