UMIN-CTR Clinical Trial

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