UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030809
Receipt number R000035174
Scientific Title Effects of narrow-band ultraviolet-B irradiation on gene expression of histamine H1 receptor and allergy-related cytokines in nasal mucosa of patients with allergic rhinitis.
Date of disclosure of the study information 2018/02/19
Last modified on 2019/04/11 17:50:47

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Basic information

Public title

Effects of narrow-band ultraviolet-B irradiation on gene expression of histamine H1 receptor and allergy-related cytokines in nasal mucosa of patients with allergic rhinitis.

Acronym

Effects of narrow-band ultraviolet-B irradiation on gene expression of histamine H1 receptor and allergy-related cytokines in nasal mucosa of patients with allergic rhinitis.

Scientific Title

Effects of narrow-band ultraviolet-B irradiation on gene expression of histamine H1 receptor and allergy-related cytokines in nasal mucosa of patients with allergic rhinitis.

Scientific Title:Acronym

Effects of narrow-band ultraviolet-B irradiation on gene expression of histamine H1 receptor and allergy-related cytokines in nasal mucosa of patients with allergic rhinitis.

Region

Japan


Condition

Condition

Allergic rhinitis

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In the present study, an attempt is made to examine the effects of intranasal irradiation with narrow-band ultraviolet-B on gene expression of histamine H1 receptor and allergy-related cytokines in nasal mucosa of patients with allergic rhinitis. After intranasal irradiation with narrow-band ultraviolet-B was given once or once a day for 3 days, changes in levels of histamine H1 receptor and allergy-related cytokine mRNAs in the nasal mucosa are examined.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Gene expression of histamine H1 receptor and allergy-related cytokines (IL-4, 5 and 9) in the nasal mucosa

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

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Intranasal irradiation of narrow-band ultraviolet-B once or once a day for 3 days

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

20 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

Adult patients with allergic rhinitis

Key exclusion criteria

Patients who was excluded by investigators

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Noriaki Takeda

Organization

University of Tokushima School of Medicine

Division name

Department of Otolaryngology

Zip code


Address

3-18-15 Kuramoto, Tokushima, Japan

TEL

088-633-7169

Email

takeda@tokushima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Noriaki Takeda

Organization

University of Tokushima School of Medicine

Division name

Department of Otolaryngology

Zip code


Address

3-18-15 Kuramoto, Tokushima, Japan

TEL

088-633-7169

Homepage URL


Email

takeda@tokushima-u.ac.jp


Sponsor or person

Institute

University of Tokushima

Institute

Department

Personal name



Funding Source

Organization

Japan Agency of Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

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

2018 Year 02 Month 19 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

Completed

Date of protocol fixation

2018 Year 01 Month 04 Day

Date of IRB

2018 Year 02 Month 19 Day

Anticipated trial start date

2018 Year 02 Month 26 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 01 Month 15 Day

Last modified on

2019 Year 04 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035174


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name