UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038110
Receipt number R000043440
Scientific Title Comparative analysis of the profiles of sebum-derived and stratum corneum-derived component
Date of disclosure of the study information 2019/10/01
Last modified on 2020/03/31 13:06:53

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Basic information

Public title

Comparative analysis of the profiles of sebum-derived and stratum corneum-derived component

Acronym

Comparative analysis of the profiles of sebum-derived and stratum corneum-derived component

Scientific Title

Comparative analysis of the profiles of sebum-derived and stratum corneum-derived component

Scientific Title:Acronym

Comparative analysis of the profiles of sebum-derived and stratum corneum-derived component

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the profiles of sebum-derived and stratum corneum-derived component

Basic objectives2

Others

Basic objectives -Others

To compare the profiles of sebum-derived and stratum corneum-derived component

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Comparison of the profiles of sebum-derived and stratum corneum-derived component

Key secondary outcomes

Comparison of the yield and analysis accuracy of sebum-derived and stratum corneum-derived component


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

20 years-old <=

Age-upper limit

59 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Healthy male and females who are 20-59 years old.
2) Subjects who can provide informed consent.

Key exclusion criteria

1) Subjects who have the skin diseases, such as atopic dermatitis, acne vulgaris, and psoriasis vulgaris.
2) Subjects who have excessive sunburn on face.
3) Subjects who regularly use over-the-counter or prescription drugs.
4) Subjects who regularly visit hospital or who visit hospital due to diseases within a month.
5) Subjects who recently receive beauty treatment or who have received beauty medical care thus far.
6) Subjects who are in irregular menstruation or who passed over the menopause.
7) Subjects who are in pregnancy or lactating period, or who have a possibility of pregnant during the study period.
8) Subjects who use prescription topical agents on face
9) Subjects who use the prescription drugs having any effects to this study.
10) Subjects who are deemed inappropriate to participate in this study by the principle investigator.

Target sample size

20


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 Michiko
Middle name
Last name Yano

Organization

Kao Corporation

Division name

Biological Science Research

Zip code

321-3497

Address

2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, Japan

TEL

+81-285-68-7888

Homepage URL


Email

yano.michiko@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

+81-3-5630-7263

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

花王株式会社(栃木県)


Other administrative information

Date of disclosure of the study information

2019 Year 10 Month 01 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

2019 Year 09 Month 18 Day

Date of IRB

2019 Year 09 Month 18 Day

Anticipated trial start date

2019 Year 10 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



Other

Other related information

Comparative analysis of the profiles of sebum-derived and stratum corneum-derived component


Management information

Registered date

2019 Year 09 Month 26 Day

Last modified on

2020 Year 03 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043440


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name