UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046878 |
|---|---|
| Receipt number | R000053485 |
| Scientific Title | The protection effectiveness of lava and ignimbrite from metal allergy. |
| Date of disclosure of the study information | 2022/02/16 |
| Last modified on | 2022/02/10 09:23:36 |
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Basic information
Public title
The protection effectiveness of lava and
ignimbrite from metal allergy.
Acronym
The protection effectiveness of lava and
ignimbrite from metal allergy.
Scientific Title
The protection effectiveness of lava and
ignimbrite from metal allergy.
Scientific Title:Acronym
The protection effectiveness of lava and
ignimbrite from metal allergy.
Region
| Japan |
Condition
Condition
metal allergy
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this examination is to confirm the metal allergy protection efficacy of lava and ignimbrite.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
After we sticked the nickel with coated lava and ignimbrite,2,3 and 7days later, check whether there is any allergy reaction
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
After reagent sticked on the skin for two days, check whether or not allergy reaction, on 2,3 and 7days.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Normal subject
Key exclusion criteria
The person who has nickel allergy.
Target sample size
95
Research contact person
Name of lead principal investigator
| 1st name | hatanaka |
| Middle name | |
| Last name | miho |
Organization
kagoshima univercity
Division name
Dermatology
Zip code
890-8520
Address
8-35-1 Sakuragaoka, Kagoshima
TEL
0992755388
meifan@m2.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | hatanaka |
| Middle name | |
| Last name | miho |
Organization
kagoshima univercity
Division name
Dermatology
Zip code
8900068
Address
8-35-1 Sakuragaoka, Kagoshima
TEL
0992755388
Homepage URL
meifan@m2.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima university hospital
Department of dermatology
Institute
Department
Personal name
Funding Source
Organization
Sankei science Foundation Research Grant
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
kagoshima univercity
Address
8-35-1 Sakuragaoka, Kagoshima
Tel
0992755388
meifan@m2.kufm.kagoshima-u.ac.jp
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
鹿児島大学病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 16 | 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
12
Results
Lava and ignimbrite could'nt prevent nickel allergy.
Results date posted
| 2022 | Year | 02 | Month | 10 | Day |
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
| 2021 | Year | 01 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 01 | 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
| 2022 | Year | 02 | Month | 10 | Day |
Last modified on
| 2022 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053485
