UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037251 |
|---|---|
| Receipt number | R000042477 |
| Scientific Title | A study to evaluate the effect after using diaper VIII |
| Date of disclosure of the study information | 2019/07/22 |
| Last modified on | 2020/01/06 12:05:48 |
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Basic information
Public title
A study to evaluate the effect after using diaper VIII
Acronym
A study to evaluate the effect after using diaper VIII
Scientific Title
A study to evaluate the effect after using diaper VIII
Scientific Title:Acronym
A study to evaluate the effect after using diaper VIII
Region
| Asia(except 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
Dermatological assessment before and after using diaper for 2, 4 weeks
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Sample(H) (2weeks)=>Sample(S) (2weeks)
Interventions/Control_2
Sample(T) (2weeks)=>Sample(J) (2weeks)
Interventions/Control_3
Sample(S) (2weeks)=>Sample(H) (2weeks)
Interventions/Control_4
Sample(J) (2weeks)=>Sample(T) (2weeks)
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
| 24 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy baby
Key exclusion criteria
1. Baby with skin trouble (atopic dermatitis, allergic dermatitis, psoriasis, serious dermatitis)
2. Baby with any disease among chronic disease, congenital disorder and infections disorder.
3. Baby under medical treatment or on medication for skin trouble
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Haruko |
| Middle name | |
| Last name | Toyoshima |
Organization
Kao Corporation
Division name
Sanitary Products Research
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
0285-68-7781
toyoshima.haruko@kao.com
Public contact
Name of contact person
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Hayashi |
Organization
Kao Corporation
Division name
Sanitary Products Research
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
0285-68-7781
Homepage URL
hayashi.kazuhiko@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
Mithra Biotechnology
Taipei Medical University
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
uesaka.toshio@kao.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
Taipei Medical University
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 22 | 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
97
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
| 2019 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 22 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 03 | Day |
Last modified on
| 2020 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042477
