UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Rubbing test of skin
Title of the study (Brief title)	Rubbing test of skin
Region	Japan

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

Objectives
Narrative objectives1	The objective of this study is to evaluate the effect of rubbing on the skin
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Measurement of the skin condition rubbing with the non-woven. The number of the sample is 3. Only once is tested by each sample.
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	Rub the medial side of the forearm with the non-woven. This is performed repeatedly using 3 types of non-woven.
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	50 years-old >
Gender	Female
Key inclusion criteria	Healthy females
Key exclusion criteria	-Individuals with the skin symptom such as atopic dermatitis. -Individuals need a doctor's visit by illness. -Individuals with hyper sensitive skin. -Individuals with wound or eczema on their forearm.
Target sample size	10

Research contact person
Name of lead principal investigator	Kenji Andou
Organization	Kao Corporation
Division name	R&D -Development Research- Sanitary Products Research
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	0285-68-7444
Email	ando.kenji@kao.co.jp

Public contact
Name of contact person	Erika Watanabe
Organization	Kao Corporation
Division name	R&D -Development Research- Sanitary Products Research
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	0285-68-7596
Homepage URL
Email	watanabe.erika3@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（栃木県）

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 22 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 10 Month 20 Day
Anticipated trial start date	2015 Year 10 Month 22 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	2015 Year 10 Month 20 Day
Last modified on	2016 Year 10 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022469