UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical setting of photodynamic therapy for the allergic rhinitis
Title of the study (Brief title)	Photodynamic therapy for the allergic rhinitis
Region	Japan

Condition
Condition	Allergic rhinitis
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Safety
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	complication
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	Medicine Maneuver
Interventions/Control_1	Photodynamic therapy for one day
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	Patients of perennial allergic rhinitis over 2 consecutive years Patients having specific antibody (mite and/or house dust) over class 2 (ImmunoCap) Positive for skin prick test
Key exclusion criteria	Having the medicine that would couse photosensitivity Having hepatic dysfunction, renal dysfunction or cardiac dysfunction porphyria patient
Target sample size	12

Research contact person
Name of lead principal investigator	Yoshitaka Okamoto
Organization	Graduate School of Medicine, Chiba University
Division name	Otolaryngology, Head and Neck Surgery
Address	1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL	+81-43-226-2137
Email	ttn3hyi@yahoo.co.jp

Public contact
Name of contact person	Takeshi Suzuki
Organization	Graduate School of Medicine, Chiba University
Division name	Otolaryngology, Head and Neck Surgery
Address	1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL	+81-43-226-2137
Homepage URL
Email	ttn3hyi@yahoo.co.jp

Sponsor
Institute	Graduate School of Medicine, Chiba University
Institute
Department

Funding Source
Organization	Grant-in-Aid for Young Scientists(B)
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2015 Year 09 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 11 Day
Anticipated trial start date	2015 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 08 Month 27 Day
Last modified on	2016 Year 09 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021737