UMIN-CTR Clinical Trial

Basic information
Public title	Patch test of Cosmetic raw materials
Acronym	Patch test of Cosmetic raw materials
Scientific Title	Patch test of Cosmetic raw materials
Scientific Title:Acronym	Patch test of Cosmetic raw materials
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
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	Female
Key inclusion criteria	1)20 to 60-year-old Japanese female 2) 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
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	03-3248-2207
Homepage URL
Email	kanekohrk@nichirei.co.jp

Sponsor
Institute	SOUKEN
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	03-3248-2207
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	2019 Year 07 Month 26 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	20
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 05 Month 27 Day
Date of IRB	2019 Year 06 Month 03 Day
Anticipated trial start date	2019 Year 07 Month 01 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 07 Month 26 Day
Last modified on	2019 Year 07 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042389