A Randomized Trial of Intratympanic Drug Delivery: Evaluating the Efficacy and Safety of Dexamethasone-Loaded Exosomes Versus Standard Therapy in Acute Sensorineural Hearing Loss.
Key facts
- Where
- Kafr ash Shaykh, EgyptSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07568184, who can take part
Where in Egypt
- Kafrelsheikh UniversityKafr ash Shaykh, EgyptContact: Haitham Hassan ElfarargyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Kafrelsheikh University
- Trial code
- NCT07568184
- Record updated
- 5 May 2026
- Original description
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.Read full original descriptionShow less
A Phase II, Randomized Trial of Intratympanic Drug Delivery: Evaluating the Efficacy and Safety of Dexamethasone-Loaded Exosomes Versus Standard Therapy in Acute Sensorineural Hearing Loss.
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 (defined as >10 dB improvement in PTA or recovery to within 10 dB of contralateral ear) among the three treatment groups at 1, 4, and 12 weeks. 3. To assess changes in auditory function via Auditory Brainstem Response (ABR) thresholds and Otoacoustic Emissions (OAEs). 4. To characterize the pharmacokinetics and inner ear biodistribution of Exo-Dex using advanced imaging modalities (e.g., MRI with exosome-contrast agents in a sub-study cohort if applicable).
Inclusion: Adults aged 18-65 years; Diagnosis of idiopathic SSNHL (≥30 dB sensorineural loss at three consecutive frequencies) within 14 days of symptom onset; Failed initial standard systemic steroid therapy (e.g., oral prednisone 1 mg/kg/day for 7-14 days) or presented with contraindications to systemic steroids; Willing and able to provide written informed consent.
Exclusion: Identifiable cause of hearing loss (e.g., acoustic neuroma, Meniere's disease, trauma); Active middle ear infection or tympanic membrane perforation; History of autoimmune disease, coagulation disorders, or immunodeficiency; Known hypersensitivity to dexamethasone or components of the exosome formulation; Pre-existing severe to profound hearing loss in the affected ear; Pregnancy or lactation; Participation in another interventional clinical trial within 30 days.