UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063093 |
|---|---|
| Receipt number | R000072221 |
| Scientific Title | Development of a feasible methodology for co-production personalized newborn skin care plans |
| Date of disclosure of the study information | 2026/09/29 |
| Last modified on | 2026/09/29 12:15:49 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Development of a feasible methodology for co-production personalized newborn skin care plans
Acronym
Co-production personalized newborn skin care plans
Scientific Title
Development of a feasible methodology for co-production personalized newborn skin care plans
Scientific Title:Acronym
co-production personalized newborn skin care plans
Region
| Japan |
Condition
Condition
Healthy infants
Classification by specialty
| Nursing | Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will develop a communication tool to facilitate discussions between parents and healthcare professionals regarding infants' skincare, taking into account differences in infants' skin conditions, allergic factors, environmental conditions, and skincare habits in various regions and households. We will then implement a program for creating skincare plans using this tool and evaluate parents' confidence in childcare, their adherence to the skincare regimen, and the infants' skin conditions to assess the tool's practicality.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Karitane Parenting Confidence Scale: KPCS
Key secondary outcomes
Skincare adherence
Presence or absence of skin problems
Skin barrier function (transepidermal water loss [TEWL], stratum corneum hydration [SCH], sebum levels, and skin surface pH)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
A program using a co-production personalized newborn skin care plans
Interventions/Control_2
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 | months-old | <= |
Age-upper limit
| 6 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
Infants under 6 months of age and their parents
Key exclusion criteria
Parent(s) who are unable to visit the study site.
Parent(s) with difficulty reading, writing, or communicating in Japanese.
Infants diagnosed with and currently receiving treatment for congenital skin disorders or atopic dermatitis.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Megumi |
| Middle name | |
| Last name | Haruna |
Organization
The University of Tokyo
Division name
Department of Women's Health and Midwifery
Zip code
113-0033
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-3396
boseikango@m.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Yonezawa |
Organization
The University of Tokyo
Division name
Department of Women's Health and Midwifery
Zip code
113-0033
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-3396
Homepage URL
boseikango@m.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Office for Human Research Studies(OHRS), raduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 29 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 29 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 29 | Day |
Last modified on
| 2026 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072221
