UMIN-CTR Clinical Trial

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
Institute	Kao Corporation
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039369