臨床研究等提出・公開システム

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

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

Hato Naohito

Ehime University Hospital

Shitsukawa454, Toon, Ehime, Japan

nhato@m.ehime-u.ac.jp

Aoishi Kunihide

Ehime University Hospital

Shitsukawa454, Toon, Ehime, Japan

+81-89-960-5366

aoishi.kunihide.ao@ehime-u.ac.jp

Recruiting

Aug. 14, 2024

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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

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

Both

olfactory disorder

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

olfactory disorder

local administration

D000857

D000287

Improvements in average cognitive thresholds three months after treatment

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

+81-89-960-5172

July. 22, 2024

none