UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035633 |
|---|---|
| Receipt number | R000040593 |
| Scientific Title | Patch test of Cosmetic raw material G |
| Date of disclosure of the study information | 2019/02/01 |
| Last modified on | 2019/07/26 13:09:42 |
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Basic information
Public title
Patch test of Cosmetic raw material G
Acronym
Patch test of Cosmetic raw material G
Scientific Title
Patch test of Cosmetic raw material G
Scientific Title:Acronym
Patch test of Cosmetic raw material G
Region
| Japan |
Condition
Condition
Healthy adults.
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
safety test
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety test of Cosmetic raw material G
Confirm skin reaction (contact dermatitis)
Key secondary outcomes
Not applicable
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
Vaseline, Saline
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
20 to 60-year-old Japanese and the person who come to the designated facility on the scheduled arrival date
Key exclusion criteria
1) The person with skin hypersensitivity
2) The person with contact allergy or those who are likely to have allergic symptoms
3) The person who are taking or applying drugs that are likely to affect the results of the examination
4) The person currently attending dermatology department
5) The person who may be pregnant or may be pregnant, and those who are breastfeeding
6) The person who are not suitable as subjects of patch test due to acne, pimples (wide range), spots (wide range), scratches, tattoos, warts, burn marks, etc. at the place where the test article is affixed
7) The person who has an anamnesis and current disease that seems to be inappropriate for this patch test
8) The person who need assistance by others and who can not walk independently
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Kaneko |
Organization
Nichirei Biosciences INC.
Division name
Functional Materials
Zip code
104-8402
Address
6-19-20, Tsukiji, Chuo-ku, Tokyo
TEL
03-3248-2207
kanekohrk@nichirei.co.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Kaneko |
Organization
Nichirei Biosciences INC.
Division name
Functional Materials
Zip code
104-8402
Address
6-19-20, Tsukiji, Chuo-ku, Tokyo
TEL
03-3248-2207
Homepage URL
kanekohrk@nichirei.co.jp
Sponsor or person
Institute
SOUKEN
Institute
Department
Personal name
Funding Source
Organization
Nichirei Biosciences INC.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nichirei Biosciences INC.
Address
6-19-20, Tsukiji, Chuo-ku, Tokyo
Tel
03-3248-2207
kanekohrk@nichirei.co.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | 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
| 2019 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 28 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 23 | Day |
Last modified on
| 2019 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040593
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
