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

Hearing Loss, Sensorineural Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06437054
• Other study ID #: ITV-2309-098-1469
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: February 15, 2025
• Est. completion date: September 30, 2028

Study information

• Verified date: May 2024
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 26
• Est. completion date: September 30, 2028
• Est. primary completion date: February 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural
• Hearing Loss, Sudden

Intervention

Drug:
• Dexamethasone
Dexamethasone 5mg/ml
• Hyaluronic acid
Hyaluronic Acid 20mg/2ml

Other:
• Indocyanine green(ICG)
ICG 25mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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