UMIN-CTR Clinical Trial

Basic information
Public title	Open test of skin care products for newborns.
Acronym	Newborn skin care use test.
Scientific Title	Open test of skin care products for newborns.
Scientific Title:Acronym	Newborn skin care use test.
Region	Japan

Condition
Condition	Healthy individual.
Classification by specialty	Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Observation of skin condition when a child from 1 week after birth to 3 months of age uses skin care products (whole body cleansing,skin lotion,skin cream).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Doctor's visual inspection(Implemented in 1 months after birth and 3 months after birth. Skin care supplies are used from 1 week after birth to 3 months after birth.)
Key secondary outcomes	Questionnaire questionnaire, subject background investigation

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	whole body cleansing,skin lotion,skin cream(Skin care supplies are used from 1 week after birth to 3 months after birth.)
Interventions/Control_2	Non-intervention (elected by subjects who do not have special skin care)
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	1 weeks-old <=
Age-upper limit	12 weeks-old >
Gender	Male and Female
Key inclusion criteria	Healthy newborn baby the doctor judged to be suitable clinical trial participants.
Key exclusion criteria	1) have a chronic illness 2) have severe skin symptoms, are currently in the hospital 3) suffer from an infectious disease 4) suffering from atopic dermatitis 5) Judging that the doctor in charge of examination is inappropriate as a clinical study participant 6) Frequent diarrhea
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Koji Middle name Last name Habe, M.D.,Ph.D.
Organization	Mie University Graduate School of Medicin
Division name	Clinical medicine course Dermatology
Zip code	514-8507
Address	2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL	059-232-1111
Email	habe-k@clin.medic.mie-u.ac.jp

Public contact
Name of contact person	1st name Koji Middle name Last name Umeda,Ph.D.
Organization	KSK Laboratories,Inc.
Division name	representative
Zip code	514-0027
Address	t.c.p 4F,7-15 Daimon, Tsu, Mie 514-0027, Japan
TEL	059-253-8091
Homepage URL
Email	info@ksk-lab.co.jp

Sponsor
Institute	Mie University, Graduate School of Medicine.
Institute
Department

Funding Source
Organization	Research funds obtained from KAO CO., LTD. are received by KSK Laboratories,Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Mie University Medical Hospital Clinical Research Ethics Review Committee
Address	2-174 Edobashi, Tsu City, Mie Prefecture
Tel	059-231-5261
Email	s-kikaku2@mo.medic.mie-u.ac.jp

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	白子ウィメンズホスピタル（三重県鈴鹿市）、三重大学 総合研究棟２（三重県津市）

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 16 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 15 Day
Date of IRB	2017 Year 01 Month 04 Day
Anticipated trial start date	2017 Year 01 Month 07 Day
Last follow-up date	2017 Year 05 Month 30 Day
Date of closure to data entry	2017 Year 09 Month 30 Day
Date trial data considered complete	2017 Year 12 Month 30 Day
Date analysis concluded	2019 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2016 Year 12 Month 16 Day
Last modified on	2019 Year 10 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029106