UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050625 |
|---|---|
| Receipt number | R000055815 |
| Scientific Title | A study of the concentration of povidone-iodine that causes false positive in intradermal test |
| Date of disclosure of the study information | 2023/03/20 |
| Last modified on | 2024/03/29 15:08:50 |
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Basic information
Public title
A study of the concentration of povidone-iodine that causes false positive in intradermal test
Acronym
A study of the concentration of povidone-iodine that causes false positive in intradermal test
Scientific Title
A study of the concentration of povidone-iodine that causes false positive in intradermal test
Scientific Title:Acronym
A study of the concentration of povidone-iodine that causes false positive in intradermal test
Region
| Japan |
Condition
Condition
not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to study the concentration of povidone-iodine that causes false negative positive in intradermal test
Basic objectives2
Others
Basic objectives -Others
to study the concentration of povidone-iodine that causes false negative positive in intradermal test
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
the diameter of initial wheal just after injection and 20 min post-injection at each concentration of povidone-iodine
Key secondary outcomes
none
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
| Maneuver |
Interventions/Control_1
intradermal test
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
healthy volunteer
Key exclusion criteria
Those who are allergic to ingredients of povidone-iodine
Those who are allergic to alcohol
Those who are taking drugs that may affect intradermal tests, such as steroids and antihistamines
Those who have a history of allergies due to food, medicines, or cosmetics
Those with skin disease currently being treated
Under the age of 18
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Kimitoshi |
| Middle name | |
| Last name | Nishiwaki |
Organization
Nagoya University Graduate School of Medicine
Division name
Anesthesiology
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2111
nishi@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Amano |
Organization
Nagoya University Hospital
Division name
Anesthesiology
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2111
Homepage URL
dj.yasuhige@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya 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
Nagoya University Hospital, bioethics committee
Address
65 Tsurumai-cho, Showa-ku, Nagoya
Tel
052-744-2111
ethics@med.nagoya-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
名古屋大学医学部附属病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 20 | 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
4
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
| 2022 | Year | 09 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 29 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 29 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 18 | Day |
Last modified on
| 2024 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055815
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
