UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study to evaluate the effect after using baby diaper
Title of the study (Brief title)	A study to evaluate the effect after using baby diaper
Region	Japan

Condition
Condition	Healthy baby
Classification by specialty	Dermatology Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the dermatological effect after using baby diaper
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Dermatological assessment before and after using diaper for 2, 4 weeks
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Diaper(H) (2weeks)-> Diaper(T) (2weeks)
Interventions/Control_2	Diaper(T) (2weeks)-> Diaper(H) (2weeks)
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	3 months-old <=
Age-upper limit	24 months-old >=
Gender	Male and Female
Key inclusion criteria	Healthy baby
Key exclusion criteria	1.Babies who have chronic illness and congenital illness. 2.Babiess who have a skin trouble (atopic dermatitis, allergic dermatitis, psoriasis, critical ermatitis). 3.Babies who have applied going to hospital regularly, a therapy or medication, and medicine in the skin trouble. 4.Presence of systemic illness. 5.Babies who judged that an examination doctor in attendance was unsuitable. 6.Babies who experience diarrhea during screening.
Target sample size	100

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	神奈川県立こども医療センター（神奈川県）

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 02 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 29 Day
Anticipated trial start date	2016 Year 04 Month 02 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 03 Month 29 Day
Last modified on	2017 Year 04 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024984