UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043425 |
|---|---|
| Receipt number | R000049582 |
| Scientific Title | Evaluation of allergic contact dermatitis of cosmetic ingredients |
| Date of disclosure of the study information | 2021/03/01 |
| Last modified on | 2021/08/17 09:05:31 |
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Basic information
Public title
Evaluation of allergic contact dermatitis of cosmetic ingredients
Acronym
Evaluation of allergic contact dermatitis of cosmetic ingredients
Scientific Title
Evaluation of allergic contact dermatitis of cosmetic ingredients
Scientific Title:Acronym
Evaluation of allergic contact dermatitis of cosmetic ingredients
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
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
Confirm skin reaction (contact dermatitis)
24h-closed patch of extract (cosmetic materials) on the back and upper arm.
Remove the sample after 24 hours. This is done three times a week for three weeks, for a total of nine times.
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
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
24h-closed patch of extract (cosmetic materials) on the back and upper arm.
Remove the sample after 24 hours. This is done three times a week for three weeks, for a total of nine times.
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Healthy Japanese men and women aged 20 to 65 who do not violate the exclusion criteria
2) The person who have no experience of strong rashes caused by cosmetics in the past
3) The person who agree to participate in the exam after showing their intention to participate in the exam and understanding the explanation.
4) The person who can read, write and communicate in Japanese
Key exclusion criteria
1) The person who are currently attending dermatology
2) The person who currently have allergic skin diseases such as atopic dermatitis
3) The person who currently have skin diseases or damage on the skin of the test site
4) The person who have had psoriasis now or in the past
5) The person who are allergic to drugs and cosmetics or have an idiosyncratic constitution
6) The person who have visited the hospital due to problems with drugs and cosmetics in the past
7) The person who are pregnant, lactating, or who have a plan to become pregnant during the test
8) The person who have a disease for which the permission of the study doctor cannot be obtained, or who have a medication (anti-inflammatory drug, antiallergic drug regular use, etc.)
9) The person who have not passed at least 4 weeks since the end date of the patch test of the previous participation
10) The person who are sensitive to tape
Target sample size
50
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
0332482207
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
0332482207
Homepage URL
kanekohrk@nichirei.co.jp
Sponsor or person
Institute
701 Research Inc.
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
0332482207
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
| 2021 | 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
| 2021 | Year | 02 | Month | 26 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 02 | Month | 24 | Day |
Last modified on
| 2021 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049582
