UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043328
Receipt number R000049468
Scientific Title Patch test of Cosmetic raw materials
Date of disclosure of the study information 2021/02/16
Last modified on 2021/08/17 09:03:26

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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

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)

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

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

1) Healthy Japanese men and women aged 20 to 60 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) Healthy Japanese men and women aged 20 to 60 who do not violate the exclusion criteria
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 have visited the hospital due to problems with cosmetics in the past
6) The person who are pregnant, lactating, or who have a plan to become pregnant during the test
7) 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.)
8) The person who have not passed at least 4 weeks since the end date of the patch test of the previous participation
9) The person who are sensitive to tape

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 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

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

2021 Year 02 Month 16 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 15 Day

Date of IRB

2021 Year 02 Month 15 Day

Anticipated trial start date

2021 Year 02 Month 16 Day

Last follow-up date

2021 Year 08 Month 17 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 15 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=R000049468


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name