UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory performance comparison trial of titanium allergy diagnostic agent
Title of the study (Brief title)	Exploratory performance comparison trial of titanium allergy diagnostic agent
Region	Japan

Condition
Condition	Titanium allergy
Classification by specialty	Dermatology Dental medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To produce a diagnostic agent for titanium allergy
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Positive rate, negative rate, safety (rate of irritation response) and specificity to 0.1%, 0.5% titanium sulfate solution, 0.1% titanium chloride solution and oxidized titanium on the 7th day.
Key secondary outcomes	Expression frequency and rate of adverse events

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	Prevention
Type of intervention	Other
Interventions/Control_1	Perform patch test to healthy person with titanium sulfate solution and titanimu chloride solution and oxidized titanium, it is judged according to the criteria of International Contact Dermatitis Research Group(ICDRG) on the second, third and seventh 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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Subjects who agree to participate for a week-long study. 2.Subjects who agree for a written informed consent for participating in this study. 3. Subjects without any symptoms of allergy (allergic dermatitis, palmoplantar pustulosis and lichen planus) and titanium allergy over the past decade.
Key exclusion criteria	1. Subjects who cannot interrupt the anti-allergic drugs from 3 days before patch test to date ended. 2. Subjects who have used corticosteroid medicine internally and/or externally within 1 month prior to the study. 3. Pregnant women and women of child bearing potential. 4. Subjects who cannot give informed consent.
Target sample size	50

Research contact person
Name of lead principal investigator	Hidemi Kurihara
Organization	Hiroshima University Hospital
Division name	Department of Periodontics and Endodontics
Address	1-2-3 Kasumi, Minami-ku, Hiroshima
TEL	082-257-5663
Email	hkuri@hiroshima-u.ac.jp

Public contact
Name of contact person	Masae Kitagawa
Organization	Hiroshima University Hospital
Division name	Center of Oral Clinical Examination
Address	1-2-3 Kasumi, Minami-ku, Hiroshima
TEL	082-257-5727
Homepage URL
Email	mhiraoka@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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 03 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 10 Day
Anticipated trial start date	2016 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry	2018 Year 11 Month 30 Day
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	2016 Year 02 Month 29 Day
Last modified on	2019 Year 01 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024350