UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022687
Receipt number R000025927
Scientific Title Delayed type of allergic skin reaction to Candida Albicans in eosinophilic rhinosinusitis cases
Date of disclosure of the study information 2016/06/10
Last modified on 2016/06/10 12:06:11

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Basic information

Public title

Delayed type of allergic skin reaction to Candida Albicans in eosinophilic rhinosinusitis cases

Acronym

Delayed type of allergic skin reaction to Candida Albicans in eosinophilic rhinosinusitis cases

Scientific Title

Delayed type of allergic skin reaction to Candida Albicans in eosinophilic rhinosinusitis cases

Scientific Title:Acronym

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



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



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

1st name
Middle name
Last name Shoji Matsune

Organization

Nippon Medical School Musashikosugi Hospital

Division name

Department of Otolaryngology

Zip code


Address

1-369,Kosugithyou,Nakahara-ku,Kanagawa,JAPAN

TEL

044-733-5181

Email

sm1988@nms.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Wakayama Nozomu

Organization

Nippon Medical School Musashikosugi Hospital

Division name

Department of Otolaryngology

Zip code


Address

1-369,Kosugithyou,Nakahara-ku,Kanagawa,JAPAN

TEL

044-733-5181

Homepage URL


Email

waka84@nms.ac.jp


Sponsor or person

Institute

Nippon Medical School

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Partially published


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

Completed

Date of protocol fixation

2012 Year 05 Month 01 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025927


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name