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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025302
Receipt No. R000029106
Scientific Title Open test of skin care products for newborns.
Date of disclosure of the study information 2017/11/16
Last modified on 2019/10/01

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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