UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of various characters in sanitary products
Title of the study (Brief title)	Analysis of various characters in sanitary products
Region	Japan

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

Objectives
Narrative objectives1	Clarifying various characters in sanitary products after using them
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Analysis of various characters in sanitary products after using them
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 adults
Key exclusion criteria	1.Individuals with skin trouble on their body coverd with sanitary products. 2.Individuals of using external medicine to their body coverd with sanitary products. 3.Individuals who has a serious sickness at heart, lung, kidney, urine, etc. 4.Individuals deemed inappropriate to participate in this study by the principle investigator. 5.Pregnancies.
Target sample size	10

Research contact person
Name of lead principal investigator	Haruko Toyoshima
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	Yoshihiro Fukuoka
Organization	Kao Corporation
Division name	R&D -Development Research- Sanitary Products Research
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	0285-68-7808
Homepage URL
Email	fukuoka.yoshihiro@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 栃木事業場（栃木県）

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 12 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 01 Month 30 Day
Anticipated trial start date	2017 Year 03 Month 13 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	Many people feel discomfort, when they use sanitary products.We need to analyze various characters of sanitary products after using to improve performance of them. Therefore, we will recruit subjects by questionary investigation and analyze them particularly.

Management information
Registered date	2017 Year 01 Month 31 Day
Last modified on	2018 Year 01 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029789