UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038248
Receipt number R000043599
Scientific Title A home use test to verify the safety of cleaning cosmetic
Date of disclosure of the study information 2019/11/01
Last modified on 2020/02/03 12:53:54

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Basic information

Public title

A home use test of shampoo

Acronym

A home use test of shampoo

Scientific Title

A home use test to verify the safety of cleaning cosmetic

Scientific Title:Acronym

A home use test of shampoo

Region

Japan


Condition

Condition

Healthy child

Classification by specialty

Not applicable Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify the safety of shampoo on scalp

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Evaluation for the absence of scalp trouble after use of shampoo for 2 weeks

Key secondary outcomes



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

Treatment

Type of intervention

Other

Interventions/Control_1

Use a shampoo on head once a day for 2 weeks

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

3 months-old <=

Age-upper limit

24 months-old >=

Gender

Male and Female

Key inclusion criteria

Subject1:Child
-Healthy children (males and females) who live in Tokyo and surrounding areas
-Subjects who can visit Lab for consent and evaluations with their parent
-Subjects who wash their head with shampoo or body cleanser (include products for baby)

Subject2:Parent
-Subjects who can provide consent on a voluntary basis before this study starts
-Subjects who can wash their child's head with test sample
-Subjects who can visit Lab for consent and evaluations with their child

Key exclusion criteria

Subject1:Child
-Subjects who are under treatment for diseases
-Subjects with external injury, eczema or sudamen which could affect the evaluation in the test
-Subjects with allergy disease including atopic dermatitis
-Subjects who have caused skin allergy or hypersensitiveness by shampoo or body cleanser
-Subjects who have participated in other tests for shampoo or body cleanser in 3 months
-Subjects deemed inappropriate to participate in this study by the principle investigator

Subject2:Parent
-Subjects with external injury, eczema or sudamen on hands and it could affect the evaluation in the test
-Subjects who have caused skin allergy or hypersensitiveness by shampoo or body cleanser
-Subjects deemed inappropriate to participate in this study by the principle investigator

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Amane
Middle name
Last name Kanai

Organization

Shiba palace clinic

Division name

Dermatology

Zip code

105-0013

Address

DaiwaA Hamamatsucho Building 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN

TEL

+81-3-5408-1590

Email

jimukyoku@mail.souken-r.com


Public contact

Name of contact person

1st name Azusa
Middle name
Last name Kouno

Organization

SOUKEN

Division name

Secretariat Division

Zip code

105-0013

Address

DaiwaA Hamamatsucho Building 3F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN

TEL

+81-3-5408-1555

Homepage URL


Email

a_kouno@mail.souken-r.com


Sponsor or person

Institute

SOUKEN

Institute

Department

Personal name



Funding Source

Organization

Kao Corporation

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

Human Research Ethics Committee, Kao Corporation

Address

2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN

Tel

+81-3-5630-7263

Email

morisaki.naoko@kao.com


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

株式会社SOUKEN(東京都)


Other administrative information

Date of disclosure of the study information

2019 Year 11 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

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 24 Day

Date of IRB

2019 Year 05 Month 24 Day

Anticipated trial start date

2019 Year 11 Month 05 Day

Last follow-up date

2019 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2020 Year 02 Month 03 Day


Other

Other related information



Management information

Registered date

2019 Year 10 Month 09 Day

Last modified on

2020 Year 02 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043599


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name