A Randomized Trial of Intratympanic Drug Delivery: Evaluating the Efficacy and Safety of Dexamethasone-Loaded Exosomes Versus Standard Therapy in Acute Sensorineural Hearing Loss.
Recruiting
N/A
Interventional Study
Sensori-Neural Deafness
Exosomes
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 30 (estimated)
- Sponsor
- Kafrelsheikh University · Other
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About This Trial
Primary Objective To compare the efficacy of a single course of IT Exo-Dex versus conventional IT dexamethasone and exosome vehicle alone, as measured by the mean change in pure-tone average (PTA; 0.5, 1, 2, 4 kHz) from baseline to the 4-week post-treatment endpoint.
Secondary Objectives
1. To determine the safety and tolerability profile of IT Exo-Dex.
2. To compare the rate of hearing recovery…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Adults aged 18-65 years.
2. Diagnosis of idiopathic SSNHL (≥30 dB sensorineural loss at three consecutive frequencies) within 14 days of symptom onset.
3. Failed initial standard systemic steroid therapy (e.g., oral prednisone 1 mg/kg/day for 7-14 days) or presented with cont…
Contacts