UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Delayed type of allergic skin reaction to Candida Albicans in eosinophilic rhinosinusitis cases
Title of the study (Brief title)	Delayed type of allergic skin reaction to Candida Albicans in eosinophilic rhinosinusitis cases
Region	Japan

Condition
Condition	Eosinophirilic rinosiusitis.
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Delayed type of allergic skin reaction to Candida Albicans in eosinophilic rhinosinusitis cases
Basic objectives2	Others
Basic objectives -Others	pathophysiology of eosinophirilic rinosiusitis.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Recrudescence of postoperative eosinophirilic rinosiusitis at 3 month ago.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	Allergic skin reaction
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Bilateral sinusitis
Key exclusion criteria	Cystic disease Unilateral sinusitis Fungal rhinosinusitis Odontogenic sinusitis
Target sample size	50

Research contact person
Name of lead principal investigator	Shoji Matsune
Organization	Nippon Medical School Musashikosugi Hospital
Division name	Department of Otolaryngology
Address	1-369,Kosugithyou,Nakahara-ku,Kanagawa,JAPAN
TEL	044-733-5181
Email	sm1988@nms.ac.jp

Public contact
Name of contact person	Wakayama Nozomu
Organization	Nippon Medical School Musashikosugi Hospital
Division name	Department of Otolaryngology
Address	1-369,Kosugithyou,Nakahara-ku,Kanagawa,JAPAN
TEL	044-733-5181
Homepage URL
Email	waka84@nms.ac.jp

Sponsor
Institute	Nippon Medical School
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Nippon Medical School Musashikosugi Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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	2016 Year 06 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 05 Month 01 Day
Anticipated trial start date	2012 Year 08 Month 01 Day
Last follow-up date	2015 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 06 Month 10 Day
Last modified on	2016 Year 06 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025927