UMIN-CTR Clinical Trial

Basic information
Public title	Effects of narrow-band ultraviolet-B irradiation on gene expression of histamine H1 receptor and allergy-related cytokines induced by artificial exposure of Japanese cedar pollen in nasal mucosa in of patients with pollinosis in the off-season.
Acronym	Effects of narrow-band ultraviolet-B irradiation on gene expression of histamine H1 receptor and allergy-related cytokines induced by artificial exposure of Japanese cedar pollen in nasal mucosa in of patients with pollinosis in the off-season.
Scientific Title	Effects of narrow-band ultraviolet-B irradiation on gene expression of histamine H1 receptor and allergy-related cytokines induced by artificial exposure of Japanese cedar pollen in nasal mucosa in of patients with pollinosis in the off-season.
Scientific Title:Acronym	Effects of narrow-band ultraviolet-B irradiation on gene expression of histamine H1 receptor and allergy-related cytokines induced by artificial exposure of Japanese cedar pollen in nasal mucosa in of patients with pollinosis in the off-season.
Region	Japan

Condition
Condition	Allergic rhinitis (pollinosis)
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 up-regulation of gene expression of histamine H1 receptor and allergy-related cytokines induced by artificial exposure of Japanese cedar pollen in nasal mucosa in of patients with pollinosis. For this purpose, we use an environmental exposure unit. After intranasal irradiation with narrow-band ultraviolet-B, the patients are exposed to Japanese cedar pollen for 3 hours in the off-season. Changes in expression of histamine H1 receptor and allergy-related cytokine mRNA 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) of the nasal mucosa
Key secondary outcomes	The allergic rhinitis symptoms including sneezing, nasal discharge and nasal obstruction

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 at a dose of 150mJ/cm2 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 pollinosis.
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	081-88-633-7169
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
Institute	University of Tokushima
Institute
Department

Funding Source
Organization	Self funding
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
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	Terminated
Date of protocol fixation	2018 Year 01 Month 04 Day
Date of IRB	2018 Year 03 Month 01 Day
Anticipated trial start date	2018 Year 03 Month 01 Day
Last follow-up date	2018 Year 03 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	2018 Year 01 Month 11 Day
Last modified on	2021 Year 04 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035127