UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034528
Receipt number R000039369
Scientific Title The study to examine the relationship between menstrual cycle and skin components in healthy women.
Date of disclosure of the study information 2018/10/18
Last modified on 2020/04/17 15:51:38

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Basic information

Public title

The study to examine the relationship between menstrual cycle and skin components in healthy women.

Acronym

The study to examine the relationship between the menstrual cycle and skin components in healthy women.

Scientific Title

The study to examine the relationship between menstrual cycle and skin components in healthy women.

Scientific Title:Acronym

The study to examine the relationship between the menstrual cycle and skin components in healthy women.

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of the relationship between the skin components and the menstrual cycle on healthy woman.

Basic objectives2

Others

Basic objectives -Others

Observational study for evaluation of the relationship between the skin components and the menstrual cycle on healthy woman.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The relationship between amount of sebum and skin molecules in each menstrual phase, the menstrual, the follicular and the luteal phase.

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

45 years-old >=

Gender

Female

Key inclusion criteria

Panelists who are Japanese females ranging from 20-45 years old.

Key exclusion criteria

1.Panelists in irregular menstruation. And, panelists who passed over the menopause.
2.Panelists who has become pregnant and breast-feeding. And, panelists who have a possibility of pregnant during the study period.
3.Panelists with illnesses or diseases which in the opinion of the investigators, might interfere with the conduct of the study or the interpretation of results. Especially panelists with any skin irritation, skin condition (such as rosacea, eczema, atopic dermatitis, or psoriasis), or severe acne on their faces.
4.Panelists who has serious suntan in their faces.
5.Panelists who performs outdoor sport periodically.
6.Panelists who take any OTC or prescription medications, especially anti-inflammation agents, anti-bacterial agents, analgesic agents, hormonal agents, laxative agents, intestinal agents, etc.
7.Panelists who attend the hospital (such as gastrointestinal disease, liver disease, kidney disease, cardiovascular heart disease, skin disease, or poor physical condition). And, panelists for less than one month after attend the hospital.
8.Panelists who has seen in a spa treatment (such as chemical peeling, or laser therapy). And, panelists who has seen in a cosmetic medicine (such as cosmetic surgery, or collagen infusion).
9.Panelists who does not have a trouble in the skin of their face.

Target sample size

56


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

+81-285-68-7461

Email

inoue.takatoshi@kao.com


Public contact

Name of contact person

1st name
Middle name
Last name Natsumi Nagamori

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

nagamori.natsumi@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

SOUKEN Corporation

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

株式会社SOUKEN(東京都)


Other administrative information

Date of disclosure of the study information

2018 Year 10 Month 18 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

2018 Year 10 Month 17 Day

Date of IRB

2018 Year 10 Month 17 Day

Anticipated trial start date

2018 Year 11 Month 21 Day

Last follow-up date

2019 Year 11 Month 21 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Evaluation of the relationship between the skin components and the menstrual cycle on healthy woman.


Management information

Registered date

2018 Year 10 Month 16 Day

Last modified on

2020 Year 04 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039369


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name