A Phase 1/2 interventional study of Dexamethasone and Hyaluronic acid in Hearing Loss, Sudden, Hearing Loss, Ototoxic and Hearing Loss, Noise-Induced, sponsored by Seoul National University Hospital. Completed at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-10-24.
Sponsored by Seoul National University Hospital · Phase 1/2, Interventional, and Treatment
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.
49 studies on the registry are indexed under Hearing Loss, Sudden; 21 are open to participants now.
This study's enrollment of 15 is below the median of 72 across 39 interventional studies indexed under Hearing Loss, Sudden.
Browse Hearing Loss, Sudden studies →Seoul National University Hospital is the lead sponsor of 1,898 studies on the registry; 274 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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Exclusion Criteria:
Drug: Dexamethasone
Drug: Dexamethasone · Drug: Hyaluronic acid
Dexamethasone 5mg/ml
Hyaluronic Acid 20mg/2ml
Verification of tympanic membrane with endoscopy (Safety)
Confirming healing time of perforation and inflammation
Time frame: 3-4 weeks after intratympanic injection
Confirmation of inflammation and drug with CT imaging (Durability)
Checking a time duration of drug in middle and inner ear
Time frame: 1 day and/or 1 weeks after intratympanic injection
Valuation of hearing threshold with Pure tone audiometry (Efficacy)
Verifying therapeutic effect of intratympanic drug delivery vehicle
Time frame: 3-4 weeks after intratympanic injection
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Hyaluronic Acid
Seoul National University Hospital →