UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030179
Receipt number R000034472
Scientific Title Research on hair and skin of women.
Date of disclosure of the study information 2017/12/01
Last modified on 2023/06/05 15:38:06

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Basic information

Public title

Research on hair and skin of women.

Acronym

Research on hair and skin of women.

Scientific Title

Research on hair and skin of women.

Scientific Title:Acronym

Research on hair and skin of women.

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Dermatology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate fibroid properties of healthy female hair and noninvasive in vivo analysis on healthy female hair.

Basic objectives2

Others

Basic objectives -Others

Observational study

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Evaluation of fibroid properties of hair, skin water content, transepidermal water loss, lipid content and pH.

Key secondary outcomes



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

80 years-old >

Gender

Female

Key inclusion criteria

Healthy females

Key exclusion criteria

-Subjects with skin diseases such as atopic dermatitis, psoriasis and severe acne
-Subjects seemed inappropriate to participate in this study by the principle investigator
-Subjects who have medical treatment or take some medicine for their scalp or facial skin

Target sample size

6000


Research contact person

Name of lead principal investigator

1st name Len
Middle name
Last name Ito

Organization

Milbon Co., Ltd.

Division name

Development Headquarters

Zip code

534-0015

Address

2-3-35, Zengenji-cho, Miyakojima-ku, Osaka-city, Osaka, 534-0015, JAPAN

TEL

+81-6-6925-8010

Email

lito@milbon.com


Public contact

Name of contact person

1st name Yuuki
Middle name
Last name Sakurai

Organization

Milbon Co., Ltd.

Division name

Development Headquarters

Zip code

534-0015

Address

2-3-35, Zengenji-cho, Miyakojima-ku, Osaka-city, Osaka, JAPAN

TEL

+81-6-6925-8010

Homepage URL


Email

ysakurai@milbon.com


Sponsor or person

Institute

Milbon Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Central Research Institute, Milbon Co., Ltd.

Address

2-3-35, Zengenji-cho, Miyakojima-ku, Osaka-city, Osaka, JAPAN

Tel

+81-6-6925-8010

Email

ysakurai@milbon.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

株式会社ミルボン 中央研究所(大阪府)


Other administrative information

Date of disclosure of the study information

2017 Year 12 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

2017 Year 11 Month 10 Day

Date of IRB

2017 Year 11 Month 12 Day

Anticipated trial start date

2017 Year 12 Month 04 Day

Last follow-up date

2027 Year 12 Month 04 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Evaluation of fibroid properties of hair, skin water content, transepidermal water loss, lipid content and pH.


Management information

Registered date

2017 Year 11 Month 30 Day

Last modified on

2023 Year 06 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034472


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name