UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062943 |
|---|---|
| Receipt number | R000072050 |
| Scientific Title | Parallel group comparative study of diapers for infants and toddlers |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/09/16 09:59:58 |
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Basic information
Public title
A study to evaluate the effect after using baby diaper
Acronym
A study to evaluate the effect after using baby diaper
Scientific Title
Parallel group comparative study of diapers for infants and toddlers
Scientific Title:Acronym
Parallel group comparative study of diapers for infants and toddlers
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Dermatology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of improved Merries First Premium on children's skin using commercial diapers as a control
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Variations in the total value obtained from the diaper rash scores at the start and end of the trial
Key secondary outcomes
Actual measured diaper rash scores for each area at the start and end of the trial Items in the post survey's "Q3 Feelings After Using Diapers"
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Use the test diaper for 14 days.
Interventions/Control_2
Use the control diaper for 14 days.
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
| 47 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
Children 1) aged 3 months to 4 years at the time of consent acquisition,
2) using disposable diapers,
3) weighing 4-13kg at the start of the trial,
4) not attending nursery schools, certified children's centers, or daycare centers during the trial period,
5) whose diaper changes are mainly handled by the parents themselves. Parents
6) who can keep a diaper change diary for 14 days during the period (about 10 questions per exchange),
7) who can visit the facility with their child twice (the initial consultation and two weeks later),
8) who can respond to a pre-survey (1 time) of about 6 A4 pages and a post-survey (the same),
9) A parent who can agree that participation may be refused if any of the following conditions (1)-(4) are met at the start of the trial; (1) receiving outpatient treatment or medication at the start of the study, (2) having had an infectious disease (mumps, chickenpox, influenza, candidiatic dermatitis, etc.) from one month before until the start of the trial, (3) Used antibiotics and steroids from one month before the start of the study until the start of the trial, (4) with Diarrhea from one week before the start of the study until the start of the trial,
10) who can reliably meet deadlines for submitting survey and diary,
11) Children who do not participate in other monitoring activities or surveys from one week before the start of the trial until the end of the exam
Key exclusion criteria
Children 1)diagnosed with chronic or congenital diseases and visit the clinic regularly,
2) with severe skin diseases on the diaper covering and visiting the clinic,
3)currently using antibiotics or steroids and may use them during the trial period,
4)whose necks are not stable yet,
5)deemed unsuitable as trial participants by the research staff
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Fukuda |
Organization
Kao Corporation
Division name
R&D -Development Research- Sanitary Products Research
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-80-8759-1973
fukuda.yuuko1@kao.com
Public contact
Name of contact person
| 1st name | Yuuma |
| Middle name | |
| Last name | Yoshida |
Organization
DRC Corporation
Division name
Clinical trial group Test department
Zip code
530-0044
Address
3F, The 9 Tabuchi Building, 2-10-31 Higashitenma, Kita-ku, Osaka-shi, Osaka Prefecture
TEL
+81-6-6882-1130
Homepage URL
yoshida@drc-web.co.jp
Sponsor or person
Institute
DRC Corporation
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Brain Care Clinic Ethics Review Committee
Address
Hakutyo Build. 2F,2-1-2 Shinjuku,Shinjuku-ku,Tokyo
Tel
+81-6-6882-1130
ethics_board@drc-web.co.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 | 10 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 23 | 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 | 16 | Day |
Last modified on
| 2026 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072050
