UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036894
Receipt number R000042045
Scientific Title An analysis of skin surface components for infantile disease skin.
Date of disclosure of the study information 2019/07/11
Last modified on 2020/06/09 17:33:33

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Basic information

Public title

An analysis of skin surface components for infantile disease skin.

Acronym

An analysis of infantile skin surface components.

Scientific Title

An analysis of skin surface components for infantile disease skin.

Scientific Title:Acronym

An analysis of infantile skin surface components.

Region

Japan


Condition

Condition

Infants with skin disease
Infants with healthy skin

Classification by specialty

Dermatology Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To identify biological marker which characterize skin disease

Basic objectives2

Others

Basic objectives -Others

To identify biological marker which characterize skin disease

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Evaluation of skin surface components and dermatological assessment of disease/healthy skin infants.

Key secondary outcomes

Questionnaire of skin and health condition of disease/healthy skin infants.


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

72 months-old >=

Gender

Male and Female

Key inclusion criteria

Infants with skin disease
Infants with healthy skin

Key exclusion criteria

-Subjects with infectious disease
-Subjects who born within 37 weeks gestational-age
-Subjects whos weigh less than 2500 grams at birth
-Subjects whose parents disagree with participating in this study.
-Subjects with other systematic illness (ex. diabetes)
-Subjects with using medicine which effect to sebaceous secretion.(Ex. Retinoid.
-Subjects deemed inappropriate to participate in this study by the principle investigator

Target sample size

120


Research contact person

Name of lead principal investigator

1st name Takayoshi
Middle name
Last name Inoue

Organization

Kao Corporation

Division name

Biological Science Research

Zip code

321-3497

Address

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

TEL

+81-285-68-5785

Email

inoue.takayoshi@kao.com


Public contact

Name of contact person

1st name Kyoko
Middle name
Last name Shima

Organization

Kao Corporation

Division name

Biological Science Research

Zip code

321-3497

Address

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

TEL

+81-285-68-7530

Homepage URL


Email

shima.kyouko@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

uesaka.toshio@kac.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

花王株式会社(栃木県)


Other administrative information

Date of disclosure of the study information

2019 Year 07 Month 11 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

2019 Year 04 Month 01 Day

Date of IRB

2019 Year 04 Month 01 Day

Anticipated trial start date

2019 Year 06 Month 01 Day

Last follow-up date

2019 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2020 Year 06 Month 09 Day


Other

Other related information

To identify biological marker which characterize skin disease


Management information

Registered date

2019 Year 05 Month 30 Day

Last modified on

2020 Year 06 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042045


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name