UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060908 |
|---|---|
| Receipt number | R000069547 |
| Scientific Title | Survey on changes in skin condition due to female hormones around menopause |
| Date of disclosure of the study information | 2026/03/16 |
| Last modified on | 2026/03/01 12:03:25 |
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Basic information
Public title
Survey on changes in skin condition due to female hormones around menopause
Acronym
Survey on changes in skin condition due to female hormones around menopause
Scientific Title
Survey on changes in skin condition due to female hormones around menopause
Scientific Title:Acronym
Survey on changes in skin condition due to female hormones around menopause
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to survey changes in skin condition due to female hormones around menopause
Basic objectives2
Others
Basic objectives -Others
observation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. blood test
(Hematological tests, estradiol, follicle-stimulating hormone(FSH), progesterone, anti-Mullerian hormone(AMH),IL-6,CRP,TNF-alpha,total antioxidant capacity(PAO), pentosidine)
2. skin pH
6. analysis of horny cell layer
7. questionnaire
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
| 45 | years-old | <= |
Age-upper limit
| 55 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Japanese females aged 45 to 55 years old at the time of informed consent
2) Those who can consent to undergoing tape stripping, applying and removing tape to the skin 20 times on the same location on the inner upper arm
Key exclusion criteria
1) Those suspected of having, or with a history of, severe digestive, liver, kidney, cardiovascular, blood, or endocrine disorders, or malignant neoplasms
2) Those with extremely irregular eating habits
3) Those with a history of alcohol or drug dependence
4) Those who consume excessive amounts of alcohol (exceeding 20g/day) six or more days per week
5) Those with chronic inflammation (e.g., diabetes, liver disease, autoimmune disorders), kidney disease, digestive disorders, heart disease, respiratory disease, peripheral vascular disease, or other serious underlying conditions
6) Those currently undergoing treatment for any disease
7) Those currently taking medications (including over-the-counter products) or supplements with estrogenic effects
8) Those currently participating in another clinical trial, or who participated within the past month
9) Those who wish to become pregnant during the trial, are pregnant (including those who may be pregnant), or are breastfeeding
10) Those with current allergic skin conditions such as atopic dermatitis
11) Those who have experienced allergic reactions to food or cosmetics
12) Those who have undergone cosmetic medical procedures or special skincare treatments (e.g., peeling, hair removal) within 4 weeks prior to the trial start date, or plan to undergo such procedures during the trial period
13) Those who have been exposed to ultraviolet rays beyond normal daily activities (e.g., prolonged outdoor work, exercise, swimming, leisure activities) within 4 weeks prior to the trial start date, or who plan to do so during the trial period
14) Those with irregular daily rhythms, such as night shift workers or those on rotating day-night shifts
15) Those who smoke an average of 21 or more cigarettes per day
16) Those who engage in strenuous sports or are currently dieting
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kouji |
| Middle name | |
| Last name | Fukuda |
Organization
Pias Coaporation
Division name
Central Laboratory
Zip code
651-2241
Address
1-3-1 Muroya, Nishi Ward, Kobe City, Hyogo Prefecture, JAPAN
TEL
078-992-6553
kfukuda@pias.co.jp
Public contact
Name of contact person
| 1st name | Miwa |
| Middle name | |
| Last name | Kaneko |
Organization
SOUKEN Co., Ltd
Division name
Management Division
Zip code
1050013
Address
DaiwaA Hamamatsucho Bldg. 3F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL
0354081555
Homepage URL
jimukyoku@mail.souken-r.com
Sponsor or person
Institute
Pias Corporation
Institute
Department
Personal name
Funding Source
Organization
Pias 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
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1599
rinri@s-palace-clinic.com
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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 16 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 11 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 13 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
to evaluate factors related to inflammatory responses and skin barrier function on the skin surface.
Management information
Registered date
| 2026 | Year | 03 | Month | 12 | Day |
Last modified on
| 2026 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069547
