UMIN-CTR Clinical Trial

Basic information
Public title	Verification of skin care of diaper for infants
Acronym	Verification of skin care of diaper for infants
Scientific Title	Verification of skin care of diaper for infants
Scientific Title:Acronym	Verification of skin care of diaper for infants
Region	Japan

Condition
Condition	Healthy volunteer
Classification by specialty	Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of preventive effect of test sample on rough skin
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Analyzing stratum corneum by using tape-stripping method
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	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Usage of the diaper including skin care ingredients for 1 month
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	3 months-old <=
Age-upper limit	24 months-old >=
Gender	Male and Female
Key inclusion criteria	1) Healthy male and female infants using diaper with no skincare ingredients (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	5

Research contact person
Name of lead principal investigator	1st name Masashi Middle name Last name Furukawa
Organization	Daio paper corporation
Division name	Home & Personal care products, Baby care products development
Zip code	799-0431
Address	4765-11, Sangawa-cho, Shikokuchuo-shi, Ehime
TEL	0896-28-2024
Email	masashi.furukawa@daiogroup.com

Public contact
Name of contact person	1st name Yuki Middle name Last name Yamashita
Organization	Nikoderm Research Inc.
Division name	Evaluation Division
Zip code	541-0052
Address	1-6-14, Azuchimachi, Chuoku, Osaka, Japan
TEL	06-6125-3501
Homepage URL
Email	yyamashita@nikkolgroup.com

Sponsor
Institute	Nikoderm Research Inc.
Institute
Department

Funding Source
Organization	Daio paper 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	Society for Glycative Stress Research
Address	2-13-10, Shinjyuku, Shinjyukuku, Tokyo, Japan
Tel	03-6709-8842
Email	info@toukastress.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

Other administrative information
Date of disclosure of the study information	2020 Year 02 Month 02 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
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	2020 Year 01 Month 14 Day
Date of IRB	2020 Year 01 Month 31 Day
Anticipated trial start date	2020 Year 02 Month 03 Day
Last follow-up date	2020 Year 03 Month 02 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 01 Month 29 Day
Last modified on	2020 Year 07 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044807