UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of moisturizing performance of topical product for massage.
Title of the study (Brief title)	Evaluation of moisturizing performance of topical product for massage.
Region	Japan

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

Objectives
Narrative objectives1	Evaluation of moisturizing performance of topical product for massage.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change rate of stratum corneum water content, before and after application of topical product.
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	Prevention
Type of intervention	Other
Interventions/Control_1	Apply topical product once to inside of one forearm, and placebo to the other forearm.
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 males and females
Key exclusion criteria	1)Individuals who have serious diseases such as heart, lung, kidney, liver, blood, endocrine, skin, etc. 2)Maternal and lactating women 3)Individuals who have some skin diseases (atopic dermatitis and so on) 4)Individuals who have some skin troubles in applied positions 5)Individuals who have or might have same allergy of cosmetic. 6)Individuals who are judged inappropriate for the study by study director and/or study doctor 7)Individuals who judged the person in charge of the examination is inappropriate.
Target sample size	20

Research contact person
Name of lead principal investigator	Koji Morita
Organization	Kao Corporation
Division name	Hair Care Product Research
Address	2-1-3,Bunka,Sumida-ku,Tokyo, 131-8501, JAPAN
TEL	+81-3-5630-9704
Email	morita.koji@kao.com

Public contact
Name of contact person	Hiromi Yokoyama
Organization	Kao Corporation
Division name	Hair Care Product Research
Address	2-1-3,Bunka,Sumida-ku,Tokyo, 131-8501, JAPAN
TEL	+81-3-5630-9703
Homepage URL
Email	yokoyama.hiromi3@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)

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	2017 Year 12 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 12 Month 05 Day
Anticipated trial start date	2017 Year 12 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 12 Month 05 Day
Last modified on	2017 Year 12 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034575