UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032216 |
|---|---|
| Receipt number | 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 09:18:40 |
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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
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
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036741
