UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046688 |
|---|---|
| Receipt number | R000053259 |
| Scientific Title | A study to evaluate the effect after using diaper XI |
| Date of disclosure of the study information | 2022/01/21 |
| Last modified on | 2026/04/03 10:28:35 |
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Basic information
Public title
A study to evaluate the effect after using diaper XI
Acronym
A study to evaluate the effect after using diaper XI
Scientific Title
A study to evaluate the effect after using diaper XI
Scientific Title:Acronym
A study to evaluate the effect after using diaper XI
Region
| Japan |
Condition
Condition
Healthy baby
Classification by specialty
| Dermatology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the dermatological effect after using baby diaper
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin condition before the use of test diaper, after 1 weeks, after 2 weeks and 2 weeks after returning to favorite diaper.
Key secondary outcomes
Skin microflora before the use of test diaper, after 1 weeks, after 2 weeks and 2 weeks after returning to favorite diaper.
Ingredient of sebum before the use of test diaper, after 1 weeks and after 2 weeks.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Use the test diaper for 14 days, following the favorite diaper for 14 days.
Interventions/Control_2
Use the control diaper for 14 days, following the favorite 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
| 8 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
1. 3-8 months old (less than 7.5kg) Japanese infants who lives in or near Tokyo.
2. Infants who use tape-type s size diaper all day.
3. Infants whose parents admit that they are worried about diaper dermatitis.
Key exclusion criteria
1. Infants who are under medical treatment or on medication for skin trouble.
2. Infants who were diagnosed with any disease among chronic disease and congenital disorder.
3. Infants who were affected with infectious disorder from one month before the start of the test to the start of the test.
4. Infants who used antibiotics, steroids, or medicated cleaning agents from one month before the start of the test to the start of the test.
Target sample size
80
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
0285-68-7597
fukuda.yuuko1@kao.com
Public contact
Name of contact person
| 1st name | Sanae |
| Middle name | |
| Last name | Sagara |
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
0285-68-7285
Homepage URL
sagara.sanae@kao.com
Sponsor or person
Institute
Kao 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
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-9220
morisaki.naoko@kao.com
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
株式会社SOUKEN（東京都）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | Month | 21 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
76
Results
In the test-diaper group, rash scores decreased significantly after 2 weeks versus baseline and week 1, while no significant change was seen in the control group, indicating that the test diaper alleviated rash. After use, lower buttock rash scores were linked to fewer intestinal bacteria and a higher proportion of resident fungi in buttock skin flora, suggesting a change in skin microbiota.
Results date posted
| 2026 | Year | 04 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The plan was to target 80 infants, and 76 participants were obtained at the beginning of the study. Three dropped out for their own reasons and the number of participants at the end of this study was 73.
Participants at the end of this study (73 infants)
-Mean age:5.3 months (range,4 to 8 months)
-39 boys and 34 girls
Participant flow
-Participants were recruited from monitors(infants and their parents)registered with the research company
<Screening>
-Parents took pictures of the infant's diaper skin after using the current Merries diaper,and the investigators evaluated
the rash and selected the participants for the trial.
<Trial>
-Participants were divided into 2 groups
- 2-week use test of test/control diaper followed by 2-week use test of favorite diaper
- Assessment before use,after 1 week/2 weeks of use for each diaper and 2 weeks after returning to favorite diaper to be conducted
Adverse events
None
Outcome measures
Determination of rash by dermatologists on diaper skin pictures taken by parents, Buttock skin flora analysis, Questionnaire
on diaper use experience
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 01 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 21 | Day |
Last modified on
| 2026 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053259
