UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	BABY DIAPER STUDY (No.2016-001)
Title of the study (Brief title)	BABY DIAPER STUDY (No.2016-001)
Region	Asia(except 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	Safety,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	Placebo
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
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 with atopic dermatitis 2.Presence of systemic illness 3.Babies in treatment for their skin troubles 4.Babies who experience diarrhea during screening
Target sample size	180

Research contact person
Name of lead principal investigator	Yuan Chao
Organization	Shanghai Skin Diseases Hospital
Division name	Skin & Cosmetic Research Department
Address	1278 Bao De Road, Zha Bei Distrct, Shanghai, 200443, China
TEL	+86-21-61833059
Email	dermayuan@163.com

Public contact
Name of contact person	Yuan Chao
Organization	Shanghai Skin Diseases Hospital
Division name	Skin & Cosmetic Research Department
Address	1278 Bao De Road, Zha Bei Distrct, Shanghai, 200443, China
TEL	+86-21-61833059
Homepage URL
Email	dermayuan@163.com

Sponsor
Institute	Shanghai Skin Diseases Hospital
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	上海市皮膚病医院（中国上海市）

Other administrative information
Date of disclosure of the study information	2018 Year 05 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 25 Day
Anticipated trial start date	2016 Year 06 Month 23 Day
Last follow-up date	2016 Year 07 Month 26 Day
Date of closure to data entry	2017 Year 03 Month 10 Day
Date trial data considered complete	2017 Year 03 Month 10 Day
Date analysis concluded	2018 Year 05 Month 13 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.hindawi.com/journals/bmri/aip/5874184/
Results	The new material diaper is superior to the standard diaper for the prevention of diaper rash in Chinese babies.
Other related information

Management information
Registered date	2018 Year 05 Month 31 Day
Last modified on	2018 Year 05 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037416