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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039728
Receipt No. 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

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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
Email 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
Email takuya.okuoka@daiogroup.com

Sponsor
Institute Daio paper corporation
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045309

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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