UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042697
Receipt number R000048730
Scientific Title A study to evaluate the effect after using baby diaper X
Date of disclosure of the study information 2020/12/09
Last modified on 2020/12/09 10:36:39

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Basic information

Public title

A study to evaluate the effect after using baby diaper X

Acronym

A study to evaluate the effect after using baby diaper X

Scientific Title

A study to evaluate the effect after using baby diaper X

Scientific Title:Acronym

A study to evaluate the effect after using baby diaper X

Region

Japan


Condition

Condition

Healthy baby

Classification by specialty

Dermatology Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the dermatological effect after using baby diaper

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Compare both of skin condition and skin microflora before and after use of test diaper.

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

Treatment

Type of intervention

Other

Interventions/Control_1

Use the test diaper for seven days.

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

8 months-old >=

Gender

Male and Female

Key inclusion criteria

1. 3-8 months old Japanese infants who lives in or near Tokyo.
2. Infants who use tape-type s size diaper all day.
3. Infants whose parents admit that they are worried about diaper dermatitis.

Key exclusion criteria

1. Infants who are under medical treatment or on medication for skin trouble.
2. Infants who were diagnosed with any disease among chronic disease and congenital disorder.
3. Infants who were affected with infectious disorder from one month before the start of the test to the start of the test.
4. Infants who used antibiotics, steroids, or medicated cleaning agents from one month before the start of the test to the start of the test.

Target sample size

10


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


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

株式会社SOUKEN


Other administrative information

Date of disclosure of the study information

2020 Year 12 Month 09 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

Open public recruiting

Date of protocol fixation

2020 Year 06 Month 26 Day

Date of IRB

2020 Year 11 Month 26 Day

Anticipated trial start date

2020 Year 12 Month 02 Day

Last follow-up date

2020 Year 12 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 12 Month 09 Day

Last modified on

2020 Year 12 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048730


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name