UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057199 |
|---|---|
| Receipt number | R000065316 |
| Scientific Title | Research on Skin and Health During Women's Life Stages -A cross-sectional study- |
| Date of disclosure of the study information | 2025/03/05 |
| Last modified on | 2025/09/03 09:01:47 |
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Basic information
Public title
Research on Skin and Health During Women's Life Stages
-A cross-sectional study-
Acronym
Research on Skin and Health During Women's Life Stages
Scientific Title
Research on Skin and Health During Women's Life Stages
-A cross-sectional study-
Scientific Title:Acronym
Research on Skin and Health During Women's Life Stages
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Comprehensive and in-depth study on the current state of women's skin and health, with an examination of the relationships among indicators.
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Objective Skin Function-related Assessments
Subjective Skin Function-related Assessments
Key secondary outcomes
Blood, Urine and Fecal Tests
Physical Examinations
Lifestyle Surveys
Subjective Symptoms
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
| 70 | years-old | > |
Gender
Female
Key inclusion criteria
1)Women aged 20-69 years at the time of consent
2)Individuals who can attend the study site on the scheduled examination dates and undergo the required tests
3)Individuals deemed eligible for participation in this study by the investigator
Key exclusion criteria
1)Individuals with skin conditions (e.g., atopic dermatitis) receiving outpatient care or medication.
2)Individuals with implanted electronic medical devices.
3)Individuals who initiated or changed medication for chronic diseases within the past three months.
4)Individuals with current or past alcohol or drug dependence.
5)Individuals with soy allergies.
6)Individuals who underwent facial cosmetic procedures within the past six months or plan such procedures during the study.
7)Individuals who used physician-prescribed medications for dermatological or cosmetic purposes within the past six months.
8)Individuals who received facial treatments at beauty salons or aesthetic clinics within the past four weeks before the study or plan to do so during the study.
9)Individuals exposed to excessive UV radiation (e.g., outdoor activities) within the past four weeks or unable to avoid intentional sun exposure (e.g., tanning) during the study.
10)Individuals vaccinated within the past four weeks or planning vaccination during the study.
11)Individuals who used probiotics, antibiotics, or antimicrobials affecting gut microbiota within the past three weeks or plan to use them during the study.
12)Individuals who traveled abroad within the past two weeks or plan to travel during the study.
13)Individuals likely to require anti-allergy medications due to seasonal allergies (e.g., hay fever) during the study.
14)Individuals currently pregnant, breastfeeding, or planning pregnancy during the study.
15)Individuals who donated blood within the past four weeks or plan to donate during the study.
16)Individuals participating or recently participated (within four weeks) in another clinical study.
17)Individuals deemed unsuitable by the principal investigator.
Target sample size
275
Research contact person
Name of lead principal investigator
| 1st name | Sachiyuki |
| Middle name | |
| Last name | Teramoto |
Organization
FANCL Corporation
Division name
Research Institute
Zip code
244-0806
Address
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL
045-820-3425
sateramoto@fancl.co.jp
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
03-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
FANCL Corporation
Institute
Department
Personal name
Funding Source
Organization
FANCL Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
03-6240-1162
jimukyoku@tes-h.co.jp
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
うえのあさがおクリニック (東京都)/Ueno-Asagao Clinic
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 05 | 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
| 2025 | Year | 02 | Month | 04 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design : a cross-sectional study
Management information
Registered date
| 2025 | Year | 03 | Month | 04 | Day |
Last modified on
| 2025 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065316
