JPRN-jRCTs061220098
Recruiting
Phase 2
Evaluation of the regeneration facilitating effects of facial nerve decompression using basic fibroblast growth factor for severe facial paralysis
Hato Naohito0 sites96 target enrollmentFebruary 20, 2023
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Bell's palsy, Ramsay Hunt syndrome, or facial paralysis caused by temporal bone fracture
- Sponsor
- Hato Naohito
- Enrollment
- 96
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. patients with Bell's palsy, Ramsay Hunt Syndrome, or facial paralysis caused by temporal bone fracture
- •2\.cases within 4 months from 2 weeks after paralysis onset
- •3\. 16 years or more
- •4\. having severe or complete facial paralysis corresponding to House\-Brackmann (H\-B) grade 5 or 6, or
- •Yanagihara score 10 or less
- •5\. having a degree of denervation exceeding 95% as determined through electroneuronography
- •6\. provided informed consent by the individual or surrogate.
Exclusion Criteria
- •1\. having a history of malignancies or currently undergoing treatment
- •2\. being pregnant or may be pregnant or lactating mothers
- •3\. patients with chronic kidney failure or liver failure
- •4\. patients with a compromised immune system
- •5\. do not wish to undergo facial nerve decompression
- •6\. having a history of allergy to gelatin or trafermin
Outcomes
Primary Outcomes
Not specified
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