UMIN-CTR Clinical Trial

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
Email	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
Email	kanekohrk@nichirei.co.jp

Sponsor
Institute	701 Research Inc.
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049582