UMIN-CTR Clinical Trial

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
Institute	SOUKEN
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043599