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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032216
Receipt No. R000036741
Scientific Title The study to examine the relationship between menstrual cycle and skin conditions in healthy women.
Date of disclosure of the study information 2018/04/23
Last modified on 2019/04/12

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Basic information
Public title The study to examine the relationship between menstrual cycle and skin conditions in healthy women.
Acronym The study to examine the relationship between menstrual cycle and skin conditions in healthy women.
Scientific Title The study to examine the relationship between menstrual cycle and skin conditions in healthy women.
Scientific Title:Acronym The study to examine the relationship between menstrual cycle and skin conditions in healthy women.
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Dermatology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the relationship between the skin conditions and the menstrual cycle on healthy woman.
Basic objectives2 Others
Basic objectives -Others Observational Study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The relationship among the dermatological assessment, skin picture, skin moisture, transepidermal water loss, skin color, 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
49 years-old >=
Gender Female
Key inclusion criteria Panelists who are Japanese females ranging from 20-49 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 cannot refrain from facial cleansing on the days of evaluation visits.
10.Panelists who does not have a trouble in the skin of their face.
11.Panelists who does not use skin of their face other than washing their face.
12.Panelists currently participating in, or scheduled to participate in, another facial study during the study period.
13.Panelists having any conditions which in the opinion of the investigators, might interfere with the conduct of the study or the interpretation of results.
Target sample size 10

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
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 04 Month 23 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 04 Month 18 Day
Date of IRB
2018 Year 04 Month 18 Day
Anticipated trial start date
2018 Year 05 Month 14 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The relationship among the dermatological assessment, skin picture, skin moisture, transepidermal water loss, skin color, amount of sebum and skin molecules in each menstrual phase, the menstrual, the follicular and the luteal phase.

Management information
Registered date
2018 Year 04 Month 12 Day
Last modified on
2019 Year 04 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036741

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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