UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021240 |
|---|---|
| Receipt number | R000024350 |
| Scientific Title | Exploratory performance comparison trial of titanium allergy diagnostic agent |
| Date of disclosure of the study information | 2016/03/01 |
| Last modified on | 2019/01/28 16:20:21 |
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Basic information
Public title
Exploratory performance comparison trial of titanium allergy diagnostic agent
Acronym
Exploratory performance comparison trial of titanium allergy diagnostic agent
Scientific Title
Exploratory performance comparison trial of titanium allergy diagnostic agent
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Hidemi Kurihara |
Organization
Hiroshima University Hospital
Division name
Department of Periodontics and Endodontics
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5663
hkuri@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masae Kitagawa |
Organization
Hiroshima University Hospital
Division name
Center of Oral Clinical Examination
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5727
Homepage URL
mhiraoka@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2016 | Year | 02 | Month | 10 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024350
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| Registered date | File name |
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| Registered date | File name |
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