Facial nerve regeneration surgery using fibroblast growth factor in Bell's palsy and Hunt syndrome
Phase 1
- Conditions
- Bell's palsy and Hunt syndrome
- Registration Number
- JPRN-UMIN000016334
- Lead Sponsor
- Department of Otolaryngology Head and Neck Surgery, Ehime University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
Not provided
Exclusion Criteria
The exclusion criteria are (1) pregnancy, (2) current neoplasms, (3) chronic kidney disease, (4) chronic liver disease, (5) immune-suppression (6) opt out decompression surgery
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method on-recovery rate at 12 months after disease onset. Recovery is defined as an improvement of the House-Brackmann facial grading score 1-2.
- Secondary Outcome Measures
Name Time Method on-recovery rate at 6 months after disease onset, incidence rate of sequelae at 12 months after disease onset. Postoperative bleeding which needs hemostasis in operating room and audiometric threshold elevation using air conduction pure tone audiometry at 250 Hz, 500 Hz, 1 kHz, 2 kHz, and 4 kHz test frequencies