UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025302 |
|---|---|
| Receipt number | 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 14:30:51 |
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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
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
info@ksk-lab.co.jp
Sponsor or person
Institute
Mie University, Graduate School of Medicine.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029106
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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