UMIN-CTR Clinical Trial

Basic information
Public title	A home use test to verify the ceramide retention capacity of shampoos
Acronym	A home use test of shampoos
Scientific Title	A home use test to verify the ceramide retention capacity of shampoos
Scientific Title:Acronym	A home use test of shampoos
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the mildness of shampoos on scalp
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of the amount change of ceramide in the scalp stratum corneum before and after use of shampoos for 4 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	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Use 2 kinds of shampoo on head once a day for 4 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	20 years-old <=
Age-upper limit	59 years-old >=
Gender	Male and Female
Key inclusion criteria	-Healthy males and females who work in Kao Sumida office -Subjects who have consciousness of drying sensitive skin -Subjects who can participate in this study for 28 uninterrupted days -Subjects who can accommodate restrictions (prohibition of hair coloring, bleaching, perm in a week before the day of Lab Visit) -Subjects who can provide consent on a voluntary basis before this study starts
Key exclusion criteria	-Subjects with suspected skin allergy, cutaneous hypersensitivity -Subjects who could cause skin allergy by shampoo -Subjects with external injury, surgical treatments -Subjects with atopic dermatitis, seborrheic dermatitis - Subjects with highly exposed to sun light Subjects whose hair was chemically treated in a week before the start of this study -Pregnancies -Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Yoshida
Organization	Kao Corporation
Division name	Hair Care Products Research
Zip code	131-8501
Address	2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL	+81-3-5630-9872
Email	yoshida.hiroshi1@kao.com

Public contact
Name of contact person	1st name Atsuko Middle name Last name Ebato
Organization	Kao Corporation
Division name	Hair Care Products Research
Zip code	131-8501
Address	2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL	+81-3-5630-9872
Homepage URL
Email	ebato.atsuko@kao.com

Sponsor
Institute	Kao Corporation
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	花王株式会社（東京都）

Other administrative information
Date of disclosure of the study information	2019 Year 09 Month 13 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	30
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 09 Month 17 Day
Last follow-up date	2019 Year 10 Month 20 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 09 Month 12 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=R000043316