Clinical trial NCT06437054: Verification of the Efficacy/safety of the Mixed Drug Injectable Delivery Vehicle for Treating Intractable Hearing Loss
Official title: Verification of the Efficacy/safety of the Mixed Drug Injectable Delivery Vehicle for Treating Intractable Hearing Loss (pilot Study)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Hearing Loss, Sensorineural
Hearing Loss, Sudden
Intratympanic Injection
Keywords: drug delivery
Dexamethasone
Hyaluronic acid
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2024-05-31
Enrollment: 26
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Analysis of Side Effect Rate through tympanic membrane endoscopy Imaging in 26 participants
timeFrame: 0, 1day and 1 week after intratympanic injection
measure: Analysis of Drug Duration through CT Imaging in 26 participants
timeFrame: 0, 1day and 1 week after intratympanic injection
measure: Comparison of Auditory Threshold Values Between Two Groups to Confirm Treatment Efficacy in 26 participants
timeFrame: 0, 1day, 1 week and/or 1 month after intratympanic injection
Secondary outcomes:
Other outcomes:
Locations:
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