UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039728 |
|---|---|
| Receipt number | R000045309 |
| Scientific Title | Safety and Efficacy test of diaper for infants |
| Date of disclosure of the study information | 2020/03/31 |
| Last modified on | 2020/03/06 18:44:08 |
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Basic information
Public title
Safety and Efficacy test of diaper for infants
Acronym
Safety and Efficacy test of diaper for infants
Scientific Title
Safety and Efficacy test of diaper for infants
Scientific Title:Acronym
Safety and Efficacy test of diaper for infants
Region
| Japan |
Condition
Condition
Healthy boys and girls
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of safety and Efficacy of diaper for infants
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Observation of infant buttocks by dermatologist before and after using diapers
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Observation of findings by dermatologist
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
| 6 | months-old | <= |
Age-upper limit
| 24 | months-old | > |
Gender
Male and Female
Key inclusion criteria
1.Healthy male and female infants using diaper (New born-M size).
2.Protectors who show their willingness of participating to the test, and who obtain consent to participate in the test after understanding explanation of test.
3.Protectors who can strictly follow the usage and have willingness of keep using test sample during test.
4.Protectors who have willingness of using test sample instead of everyday use diaper.
5.Protectors who are willing not to excessive sunburn.
6.Protectors who have willingness of filling out the survey and returning after test.
Key exclusion criteria
1.Those who have a current or a past medical history of drug, food or cosmetics allergy.
2.Those who used cosmetics or pharmaceutical products which might have an influence on the final examination
3.Those who have medical experience such as surgery that affects the test site
4.Others who principal investigator are not appropriate
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Okuoka |
Organization
Daio paper corporation
Division name
Products Development Headquarters
Zip code
799-0431
Address
4765-11, Sangawa-sho, Shikokuchuo-shi, Ehime
TEL
0896-28-2024
takuya.okuoka@daiogroup.com
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Okuoka |
Organization
Daio paper corporation
Division name
Products Development Headquarters
Zip code
799-0431
Address
4765-11, Sangawa-sho, Shikokuchuo-shi, Ehime
TEL
0896-28-2024
Homepage URL
takuya.okuoka@daiogroup.com
Sponsor or person
Institute
Daio paper corporation
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
701 Research Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Aesthetic Dermatology Symposium
Address
2-Chome, Minatomirai, Nishi-ku, Yokohama-shi, Kanagawa, 3rd number 5, the 8th floor of Queen's tower C ridge
Tel
045-682-4114
info@jp-ads.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 31 | 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
33
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 | 11 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2020 | Year | 03 | 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
| 2020 | Year | 03 | Month | 06 | Day |
Last modified on
| 2020 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045309
