UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study on influence of exogenous factors for skin
Title of the study (Brief title)	Influence of exogenous factors for skin
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Dermatology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to evaluate the influence of exogenous factors like hydration for skin
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Measurement of the skin condition for 30 minutes after hydration.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Hydrate medial side of the forearm by contact of moisture and water. Hydration time is less than 30 minutes.
Interventions/Control_2	Hydrate medial side of the forearm by contact of moisture and water. Hydration time is more than 30 minutes.
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	50 years-old >
Gender	Male and Female
Key inclusion criteria	Healthy adults
Key exclusion criteria	1.Individuals with skin trouble on their forearm. 2.Individuals of using external medicine to their forearm. 3.Individuals who goes to hospital of department of dermatologyfor the skin symptom such as atopic dermatitis, eczema, urticaria. 4.Individuals who has a serious sickness at heart, lung, kidney, urine, etc. 5.Individuals deemed inappropriate to participate in this study by the principle investigator. 6.Pregnancies. 7.Smokers.
Target sample size	10

Research contact person
Name of lead principal investigator	Toyoshima Haruko
Organization	Kao Corporation
Division name	R&D-Development Research-Sanitary Products Research
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	0285-68-7448
Email	toyoshima.haruko@kao.co.jp

Public contact
Name of contact person	Rinko Takagi
Organization	Kao Corporation
Division name	R&D-Development Research-Sanitary Products Research
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	0285-68-7448
Homepage URL
Email	takagi.rinko@kao.co.jp

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	花王株式会社テクノリサーチセンター（東京）

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 26 Day
Anticipated trial start date	2015 Year 10 Month 26 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	2016 Year 02 Month 25 Day
Last modified on	2017 Year 03 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024446