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Treatment of olfactory dysfunction by Topical Application of Basic Fibroblast Growth Factor

Treatment of olfactory dysfunction by Topical Application of Basic Fibroblast Growth Factor:pilot study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs061240046
Enrollment
20
Registered
2024-08-14
Start date
2025-01-16
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

olfactory disorder olfactory disorder

Interventions

Local administration of bFGF-impregnated gelatin hydrogel to the olfactory cleft on the first day of treatment
local administration

Sponsors

Hato Naohito
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with olfactory disorder treatment started between 4 weeks and 1 year after onset of olfactory disorder can be evaluated three months after treatment Patients with olfactory impairment with an average cognitive threshold of 2.6 or higher on the T&T olfactometer age of at least 20 to under 65 years old Written informed consent

Exclusion criteria

Exclusion criteria: When the patient cannot come to the hospital Cases with confirmed central olfactory disorders or other nasal sinus diseases (such as olfactory neuroblastoma) Cases judged inappropriate by the attending physician Patients with a history of allergy to gelatin or trafermin Patients who cannot take Tokisyakuyakusan

Design outcomes

Primary

MeasureTime frame
Improvements in average cognitive thresholds three months after treatment

Secondary

MeasureTime frame
Mean cognitive threshold and change in standard olfaction test after 1 month of treatment Percentage of "cured" and "mildly cured" after 3 months of treatment Mean cognitive threshold and amount of change after 3 months of treatment by severity Amount of change in open essences 1 month and 3 months after onset Daily Smell Questionnaire and Olfactory Disorder VAS scores at 1 month and 3 months after onset

Contacts

Public ContactKunihide Aoishi

Ehime University Hospital

aoishi.kunihide.ao@ehime-u.ac.jp+81-89-960-5366

Outcome results

None listed

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