UMIN-CTR Clinical Trial

Basic information
Public title	Intra-Tympanic Steroid Injection and Keeping Specified Head position for facial nerve palsy
Acronym	i-Siks for facial palsy
Scientific Title	Intra-Tympanic Steroid Injection and Keeping Specified Head position for facial nerve palsy
Scientific Title:Acronym	i-Siks for facial palsy
Region	Japan

Condition
Condition	peripheral facial palsy including Bell's palsy and Ranmay-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 and keeping specified head position from medical records of patients who underwent this treatment for facial nerve palsy.
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	Time it takes for signs of improvement to begin Time it takes for the disease to recover completely Incidence of adverse events

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 peripheral facial palsy and receiving systemic steroids who meet the following conditions and have a potentially poor prognosis; Yanagihara score of 8 or less and House-Brackmann grade 5 or higher, or Yanagihara score of 10-18 and House-Brackmann grade 4 without stapes reflex 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 a history of hypersensitivity to dexamethasone 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 Ktano 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
Email	riekanai.ent@gmail.com

Public contact
Name of contact person	1st name Rie Middle name Last name Kanai
Organization	Tazuke Kofukai Medical Research Institute Kitano Hospital
Division name	Department of Otolaryngology, Head & Neck Surgery
Zip code	530-84840
Address	2-4-20, Ougi-machi, Kita-ku, OSAKA, JAPAN
TEL	0663121221
Homepage URL
Email	r-kanai@kitano-hp.or.jp

Sponsor
Institute	Tazukekofukai Medical Research Institute Ktano Hospital
Institute
Department

Funding Source
Organization	Tazukekofukai Medical Research Institute Ktano Hospital
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 11 Month 06 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	Preinitiation
Date of protocol fixation	2022 Year 10 Month 12 Day
Date of IRB	2022 Year 10 Month 17 Day
Anticipated trial start date	2022 Year 11 Month 07 Day
Last follow-up date	2027 Year 10 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

The patients will be followed up for at least one year after treatment, and the following date will be investigated from the medical records : recovery rate (Yanagihara's score 36 or higher, House-Brackmann grade1) as primary outcome, and the time it takes for signs of improvement to begin, and time it takes for the disease to recover completely, and the incidence of adverse events for example, tympanic membrane perforation, middle ear infection, vertigo etc, as secondory outcomes.

Management information
Registered date	2022 Year 11 Month 06 Day
Last modified on	2022 Year 11 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055435