Verification of the Efficacy/safety of the Intratympanic Drug Delivery for Hearing Loss

NCT04766853 — Phase 1 / Phase 2, Completed, 15 participants, Seoul National University Hospital

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Verification of the Efficacy / Safety of the Intratympanic Drug Delivery Vehicle for Treating Intractable Hearing Loss (pilot Study)

Registry	NCT04766853
Status	Completed
Phase	Phase 1 / Phase 2
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	15 (Actual)
Sponsor	Seoul National University Hospital (Other)
Conditions	Hearing Loss, Sudden, Hearing Loss, Ototoxic, Hearing Loss, Noise-Induced, Meniere Disease
Interventions	Dexamethasone, Hyaluronic acid (Drug)
Dates	start 2021-07-22, primary completion 2023-04-18, completion 2024-07-19, first posted 2021-02-23, last updated 2024-10-24
Locations	1 site in South Korea

-Summary

This study is a prospective, randomized pilot study. To verify an efficacy and safety of the Intratympanic drug delivery vehicle, patients who have not responded to the existing standard treatment will be enrolled. Hearing test, endoscopy of tympanic membrane and CT scans will be conducted after intratympanic treatment for evaluation.

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+Arms and interventions

Arm	Type	Interventions	Description
Dexamethasone+Saline	Active comparator	Drug: Dexamethasone
Dexamethasone+Hyaluronic Acid	Experimental	Drug: Dexamethasone; Drug: Hyaluronic acid

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

+Outcome measures

Primary outcomes

Verification of tympanic membrane with endoscopy (Safety) [3-4 weeks after intratympanic injection]: Confirming healing time of perforation and inflammation
Confirmation of inflammation and drug with CT imaging (Durability) [1 day and/or 1 weeks after intratympanic injection]: Checking a time duration of drug in middle and inner ear
Valuation of hearing threshold with Pure tone audiometry (Efficacy) [3-4 weeks after intratympanic injection]: Verifying therapeutic effect of intratympanic drug delivery vehicle

+Eligibility

Sex: All, ages: 19 Years to any

Inclusion Criteria:

* Sudden hearing loss, ototoxic hearing loss, noise-induced hearing loss, meniere's disease patients with 25dB HL in pure tone audiometry
* Patients whose hearing has not been restored after standard treatment
* Patients do not participate in clinical trials within 6 months

Exclusion Criteria:

* Patients with retrocochlear lesion
* Patients with history of hypersensitivity to the ingredients of this drug
* Patients with end-stage renal disease, end-stage liver disease, cardiovascular surgery, progressive brain tumor, progressive palsy and progressive stroke, etc. severe brain disease or cancer.

+Locations (1)

Facility	City	Country	Status
Seoul National University Hospital	Seoul	South Korea

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