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Efficacy and safety study of intratympanic dexamethasone treatment concurrent with standard oral prednisolone treatment for facial palsy

Efficacy and safety study of intratympanic dexamethasone treatment concurrent with standard oral prednisolone treatment for facial palsy - Intratympanic dexamethasone therapy for facial palsy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000031107
Enrollment
53
Registered
2018-02-01
Start date
2014-03-26
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Facial nerve palsy

Interventions

Intratympanic dexamethasone application for 10 consecutive days

Sponsors

Nagoya City University, Graduate school of Medical sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The patients who is diagnosed as Bell's palsy or Ramsay-Hunt syndrome. The patients who can start the protocol within 7 days after onset. 20 years or older

Exclusion criteria

Exclusion criteria: Presence of non-viral inflammation in the idle ear. The presence of the carriage state of viral or bacterial disease. Middle ear or inner ear anomaly which makes it impossible to inject to the middle ear. HbA1C > 6.5% BUN >25 mg/dl or Serum creatinine level>2.0 mg/dl ALT > 100 U/l or AST > 100/l Severe protracted wound healing. Signs of central facial palsy Pregnancy, or possible pregnancy Participate in other clinical traials within 3 months Recurrent facial palsy Treatment other than 60 mg of prednisolone and 1000 mg (Bell's palsy) or 3000 mg (Hunt syndrome)of oral valaciclovir within two days straight History of facial nerve decompression surgery The patients who are considered not to be appropriate for the clinical trial

Design outcomes

Primary

MeasureTime frame
Recovery of the facial nerve grading at 1,3,6,9,12 months after intervention

Secondary

MeasureTime frame
Improvement of complete recovery rate with intervention

Countries

Japan

Contacts

Public ContactAkira Inagaki

Nagoya City University, Graduate school of Medical sciences Department of Otorhinolaryngology, Head and Neck surgery

meijo_ent@hotmail.com052-853-8256

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026