UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032983
Receipt number R000037611
Scientific Title Analyses of the skin molecules in healthy males.
Date of disclosure of the study information 2018/06/20
Last modified on 2019/01/28 16:44:36

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Basic information

Public title

Analyses of the skin molecules in healthy males.

Acronym

Analyses of the skin molecules in healthy males.

Scientific Title

Analyses of the skin molecules in healthy males.

Scientific Title:Acronym

Analyses of the skin molecules in healthy males.

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Dermatology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of the skin molecules in healthy males.

Basic objectives2

Others

Basic objectives -Others

The observational study of the skin molecules in healthy males.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The composition of the skin molecules in healthy males.

Key secondary outcomes

The relationship between skin molecules and questionnaires.


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

40 years-old <=

Age-upper limit

56 years-old >=

Gender

Male

Key inclusion criteria

1.Healthy male panelists who are 40-59 years old.
2.Panelists who agree to have their typical daily routines.

Key exclusion criteria

1.Panelists who have the skin problems on the face, such as atopic dermatitis, psoriasis vulgaris, and acnes.
2.Panelists who have a severe tanning on the face
3.Panelists who have habits of outdoor activities causing a severe tanning.
4.Panelists who use the drug such as, anti-inflammatory drug, antibiotics, hypnotic, anti- allergic drug, analgesic drug, hormone preparation, laxative, intestinal regulator, and other drugs as routinely.
5.Panelists who attend for treatment of chronic diseases (e.g. stomach, intestine, kidney, heart, blood pressure, skin, and other illness) or have history of attending within a month before participation in this study (Manual therapy, chiropractic, massages, and osteopathic manipulation are exceptional).
6.Panelists who attend cosmetic therapy (e.g. chemical peeling, laser therapy) or have history of cosmetic surgery (e.g. cosmetic orthopedics, collagen injection).
7.Panelists who have participated or scheduled in other study during the period of this study.
8.Panelists who is considered as inappropriate in this study.
9.prescription topical agents on the face

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takayoshi Inoue

Organization

Kao Corporation

Division name

Biological Science Research

Zip code


Address

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

TEL

+81-285-68-7498

Email

inoue.takayoshi@kao.com


Public contact

Name of contact person

1st name
Middle name
Last name Yuya Uehara

Organization

Kao Corporation

Division name

Biological Science Research

Zip code


Address

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

TEL

+81-285-68-7461

Homepage URL


Email

uehara.yuuya@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

Juntendo University

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2018 Year 06 Month 20 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

Terminated

Date of protocol fixation

2018 Year 06 Month 20 Day

Date of IRB


Anticipated trial start date

2018 Year 06 Month 21 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The observational study of the skin molecules in healthy males.


Management information

Registered date

2018 Year 06 Month 14 Day

Last modified on

2019 Year 01 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037611


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name