UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056777 |
|---|---|
| Receipt number | R000064860 |
| Scientific Title | Investigation of the influences of changes in female hormones (menopause) on the skin and evaluation of skin condition improvement through the use of the developed serum |
| Date of disclosure of the study information | 2025/01/31 |
| Last modified on | 2025/01/22 08:57:19 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Investigation of the influences of changes in female hormones (menopause) on the skin and evaluation of skin condition improvement through the use of the developed serum
Acronym
Investigation of the influences of changes in female hormones on the skin and evaluation of skin condition improvement through the use of the serum
Scientific Title
Investigation of the influences of changes in female hormones (menopause) on the skin and evaluation of skin condition improvement through the use of the developed serum
Scientific Title:Acronym
Investigation of the influences of changes in female hormones on the skin and evaluation of skin condition improvement through the use of the serum
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To Investigae the influences of changes in female hormones (menopause) on the skin and to evaluate of skin condition improvement through the use of the developed serum
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blood test, skin moisture content, transepidermal water loss, ultrasound imaging of derma, skin friction coefficient, skin viscoelasticity, skin color difference, Image analysis by VISIA, questionnaire, analysis of horny cell layer at 0-4-8 weeks
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
To apply serum twice a day to the face
Interventions/Control_2
To apply placebo twice a day to the face
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
| 54 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Japanese males and females aged 20 years to 59 years old at the time of informed consent
2) Those who are not menopausal and whose menstrual cycle is stable or who have already reached menopause
3) Those who are concent to use the test product in place of the daily-used emulsion or serum
4) Those who are concent not to make any changes or additions to the skin care products currently being used during the test period, other than the teste product
5) Those who are concent not to make any changes or additions to supplementsduring the test period
Key exclusion criteria
1) Those who have undergone or will undergo cosmetic medical treatment or special skin care procedures within 4 weeks prior to or during the test period
2) Those with history of allergic skin diseases such as atopic dermatitis
3) Those who have had allergic reactions to food or cosmetics
4) Currently undergoing treatment for a medical condition
5) Currently using drugs or supplements that have female hormone effects
6) Currently participating in another clinical test, or have participated in one within the past month
7) Those who are pregnant, lactating or possibly pregnant
8) Those who expose to ultraviolet radiation beyond daily activities such as prolonged outdoor work, exercise, swimming, leisure activities within 4 weeks prior to or during the test period
9) Those who have an irregular rhythm of life, such as those who work night shifts or day/night shifts
10) Those who smoke an average of 21 cigarettes or more per day
11) Those who engage in strenuous sports or are on a diet
12) Those who have extremely irregular eating habits
13) Those with a history of alcohol or drug dependence
14) Excessive alcohol consumption (more than 20g/day of alcohol) 6 or more days per week
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yukiya |
| Middle name | |
| Last name | Hisatsune |
Organization
Pias corporation
Division name
Central R&D laboratory
Zip code
651-2241
Address
1-3-1, Murotani, Nishi-ku, Kobe, Hyogo, 651-2241, JAPAN
TEL
078-992-6550
yhisatsune@pias.co.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Nagai |
Organization
SOUKEN Co., Ltd
Division name
Management Division
Zip code
105-0013
Address
DaiwaA Hamamatsucho Bldg. 3F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL
03-5408-1555
Homepage URL
jimukyoku@mail.souken-r.com
Sponsor or person
Institute
Shiba Palace Clinic
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
shiba_palace@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
| 2025 | Year | 01 | Month | 31 | 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
| 2025 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 22 | Day |
Last modified on
| 2025 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064860
