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Clinical Trials/JPRN-jRCTs061220098
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.

Registry
who.int
Start Date
February 20, 2023
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Hato Naohito

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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