UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061812 |
|---|---|
| Receipt number | R000070733 |
| Scientific Title | An Epidemiological Study of Skin Characteristics in Adult Women |
| Date of disclosure of the study information | 2026/06/06 |
| Last modified on | 2026/06/05 19:24:40 |
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Basic information
Public title
An Epidemiological Study of Skin Characteristics in Adult Women
Acronym
An Epidemiological Study of Skin Characteristics in Adult Women
Scientific Title
An Epidemiological Study of Skin Characteristics in Adult Women
Scientific Title:Acronym
An Epidemiological Study of Skin Characteristics in Adult Women
Region
| Japan |
Condition
Condition
Helthy skin
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will be conducted in 200 adult women, involving various photographic assessments and instrumental measurements. The results obtained will be used to support the design and optimization of cosmetics, quasi-drugs, and health foods, as well as the development of novel skin evaluation methods and assessment devices.
Basic objectives2
Others
Basic objectives -Others
Epidemiological Study of Skin Conditions in Japanese Women
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Facial sagging analysis using Vectra Handy imaging
Analysis of spots, wrinkles, pores, skin tone unevenness, porphyrins, subsurface pigmentation, melanin index, and hemoglobin index using VISIA Evolution imaging
Pore analysis using Antera 3D imaging
Microscopic imaging analysis
Measurement of transepidermal water loss (TEWL)
Measurement of stratum corneum hydration
Measurement of skin viscoelasticity
Tape stripping analysis, including cell area, multiple strippings, nucleated cell assessment, and skin metabolite-related markers with immunostaining
Measurement of dermal thickness using DermaLab
Pore analysis using skin replica sampling
Measurement of sebum production
Microbiome analysis based on skin sample collection
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
| 60 | years-old | >= |
Gender
Female
Key inclusion criteria
Women aged 20 years or older and under 60 years at the time of informed consent (target: approximately 50 subjects per age group)
Healthy female subjects
Subjects who have received sufficient explanation regarding the purpose and procedures of the study, possess the capacity to provide consent, fully understand the study, voluntarily agree to participate, and are able to provide written informed consent
Key exclusion criteria
Subjects with any condition at the evaluation site that may affect study results (e.g., urticaria, inflammation, eczema, wounds, acne, warts, pigmentation, or residual marks); those with a past or current history of atopic dermatitis or atopic predisposition (including family history); those who have received or plan to receive cosmetic medical procedures at the evaluation site (e.g., botulinum toxin, fillers, photofacial); those who have undergone or plan to undergo special skincare treatments (e.g., aesthetic/salon treatments) within 4 weeks; those who have changed or newly started health foods, skincare products, or sunscreen within 4 weeks; those with excessive UV exposure beyond daily life within 4 weeks or planned during the study; night shift or rotating shift workers; those receiving medical treatment at the time of consent or judged to require treatment; those with severe systemic diseases (metabolic, hepatic, renal, cardiovascular, respiratory, endocrine, immune, neurological); those with a history of alcohol or drug dependence; those at risk of allergy to cosmetics or foods (including skin reactions within 1 year); those who are pregnant, breastfeeding, or planning pregnancy; those who participated in other human studies within 4 weeks or plan to participate during the study; and those deemed unsuitable by the investigator.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kensuke |
| Middle name | |
| Last name | Yotsumoto |
Organization
ALBION CO., LTD.
Division name
R&D Laboratory
Zip code
1030004
Address
2-24-22, Higashi-nihombashi, Chuo-ku, Tokyo
TEL
07024736977
k_yotsumoto@albion.co.jp
Public contact
Name of contact person
| 1st name | Mizuho |
| Middle name | |
| Last name | Kokubo |
Organization
ALBION CO., LTD.
Division name
R&D Laboratory
Zip code
1030004
Address
2-24-22, Higashi-nihombashi, Chuo-ku, Tokyo
TEL
07024736977
Homepage URL
m_kokubo_8ff@albion.co.jp
Sponsor or person
Institute
DRC
Institute
Department
Personal name
Funding Source
Organization
ALBION CO., LTD.
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
Brain Care Clinic Ethics Review Committee.
Address
Hakutyo Build. 2F,2-1-2 Shinjuku,Shinjuku-ku,Tokyo
Tel
03-6273-2214
ethics_board@drc-web.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 06 | 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 | 04 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Facial sagging analysis using Vectra Handy imaging
Analysis of spots, wrinkles, pores, skin tone unevenness, porphyrins, subsurface pigmentation, melanin index, and hemoglobin index using VISIA Evolution imaging
Pore analysis using Antera 3D imaging
Microscopic imaging analysis
Measurement of transepidermal water loss (TEWL)
Measurement of stratum corneum hydration
Measurement of skin viscoelasticity
Tape stripping analysis, including cell area, multiple strippings, nucleated cell assessment, and skin metabolite-related markers with immunostaining
Measurement of dermal thickness using DermaLab
Pore analysis using skin replica sampling
Measurement of sebum production
Microbiome analysis based on skin sample collection
Management information
Registered date
| 2026 | Year | 06 | Month | 05 | Day |
Last modified on
| 2026 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070733
