UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040878
Receipt number R000046678
Scientific Title A study to evaluate the effect after using baby diaperIX
Date of disclosure of the study information 2020/06/26
Last modified on 2020/12/07 13:28:42

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Basic information

Public title

A study to evaluate the effect after using baby diaperIX

Acronym

A study to evaluate the effect after using baby diaperIX

Scientific Title

A study to evaluate the effect after using baby diaperIX

Scientific Title:Acronym

A study to evaluate the effect after using baby diaperIX

Region

Asia(except Japan)


Condition

Condition

Healthy infant

Classification by specialty

Dermatology Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the 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 -investigator(s) and assessor(s) 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(J) (2weeks)

Interventions/Control_2

Sample(J) (2weeks)->Sample(H) (2weeks)

Interventions/Control_3

Sample(T) (2weeks)->Sample(S) (2weeks)

Interventions/Control_4

Sample(S) (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 infant

Key exclusion criteria

1.Infant with skin disease
2.Infant with atopic dermatitis.
3.Infant diagnosed with chronic disease or congenital disorder.
4.Infant under-medication for their skin troubles.
5.Infant with diarrhea at screening.

Target sample size

120


Research contact person

Name of lead principal investigator

1st name Yuko
Middle name
Last name Fukuda

Organization

Kao Corporation

Division name

Sanitary Products Research

Zip code

321-3497

Address

2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN

TEL

0285-68-7597

Email

fukuda.yuuko1@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

0285-68-7913

Homepage URL


Email

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

Toyo Science Corp.
SMART Research Corp.
Children Hospital 2

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

Email

morisaki.naoko@kao.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

Children Hospital 2(Vietnam)


Other administrative information

Date of disclosure of the study information

2020 Year 06 Month 26 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

119

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 22 Day

Date of IRB

2020 Year 01 Month 22 Day

Anticipated trial start date

2020 Year 07 Month 20 Day

Last follow-up date

2020 Year 09 Month 18 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2019 Year 12 Month 07 Day


Other

Other related information



Management information

Registered date

2020 Year 06 Month 24 Day

Last modified on

2020 Year 12 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046678


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name