UMIN-CTR Clinical Trial

Basic information
Public title	Intra-tympanic steroid injection for peripheral facial nerve palsy
Acronym	Intra-tympanic steroid injection for peripheral facial nerve palsy
Scientific Title	Intra-tympanic steroid injection for peripheral facial nerve palsy
Scientific Title:Acronym	Intra-tympanic steroid injection for peripheral facial nerve palsy
Region	Japan

Condition
Condition	peripheral facial palsy including Bell's palsy and Ransay-Hunt syndrome
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of intra-tympanic steroid injection in patients with peripheral facial nerve palsy who may have a poor prognosis even after systemic steroid administration, and in patients who cannot receive systemic steroid administration for any reason
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Yanagihara's score, House-Brackmann grade and recovery rate 1 year after this therapy
Key secondary outcomes	The period taken facial nerve palsy to recover Incidence of adverse events

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	Patients are injected Dexamethasone into the tympanic cavity via tympanic mambrane at least 7 times.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients diagnosed with peripherai facial palsy and treated with systemic steroid therapy, who have an ENoG of 10% or less after 10 days of onset Patients diagnosed with peripheral facial palsy who are at high risk of complications from steroid administration due to their general condition or comorbidities and for whom systemic administration is not possible
Key exclusion criteria	Patients with morphological abnormalities or severe infection of the external auditory canal or middle ear
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Shin-ichi Middle name Last name Kanemaru
Organization	Tazukekofukai Medical Research Institute Kitano Hospital
Division name	Department of Otolaryngology, Head & Neck Surgery
Zip code	5308480
Address	2-4-20, Ougi-machi, Kita-ku, OSAKA, JAPAN
TEL	0663121221
Email	s-kanemaru@kitano-hp.or.jp

Public contact
Name of contact person	1st name Rie Middle name Last name Kanai
Organization	Tazukekofukai Medical Research Institute Kitano Hospital
Division name	Department of Otolaryngology, Head & Neck Surgery
Zip code	530-8480
Address	2-4-20, Ougi-machi, Kita-ku, OSAKA, JAPAN
TEL	0663121221
Homepage URL
Email	riekanai.ent@gmail.com

Sponsor
Institute	Tazukekofukai Medical Research Institute Kitano Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tazuke Kofukai Medical Research Institute Kitano Hospital
Address	2-4-20, Ougi-machi, Kita-ku, OSAKA, JAPAN
Tel	0663121221
Email	r-kanai@kitano-hp.or.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 08 Month 13 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 09 Month 28 Day
Date of IRB	2016 Year 09 Month 28 Day
Anticipated trial start date	2016 Year 09 Month 28 Day
Last follow-up date	2022 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 08 Month 13 Day
Last modified on	2022 Year 08 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055436