UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059784 |
|---|---|
| Receipt number | R000068358 |
| Scientific Title | Comparative study of gene expression in two areas of the face and one non-exposed area of women in her 50s |
| Date of disclosure of the study information | 2025/11/18 |
| Last modified on | 2025/11/14 17:14:45 |
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Basic information
Public title
Comparative study of gene expression in the face and non-exposed area of women in her 50s
Acronym
Comparative study of gene expression in the face and non-exposed area of women in her 50s
Scientific Title
Comparative study of gene expression in two areas of the face and one non-exposed area of women in her 50s
Scientific Title:Acronym
Comparative study of gene expression in two areas of the face and one non-exposed area of women in her 50s
Region
| Japan |
Condition
Condition
Skin photoaging
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we aim to clarify the expression of genes involved in photoaging by collecting skin from the face and non-exposed areas and comparing gene expression in each area.
Basic objectives2
Others
Basic objectives -Others
Elucidating the genes involved in skin photoaging
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of gene expression at each evaluation site of the skin
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
| 50 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Female
Key inclusion criteria
-Individuals who have expressed a will to participate in the study, received an explanation of the study, understood the details, and agreed to participate.
-Healthy Japanese women aged 50 to 59 who do not meet the exclusion criteria
-Individuals who are able to complete consent forms, questionnaires, and other documents.
-Individuals who are able to attend the designated facility on the measurement date.
-Individuals who are able to complete questionnaires regarding their skin condition, lifestyle habits, and current medications, supplements, and cosmetics.
Key exclusion criteria
-Subjects with trauma, eczema, or other skin conditions in the evaluation area.
-Subjects currently using topical medications in the evaluation area.
-Subjects who have undergone cosmetic medical treatment within the past year that could affect the evaluation area.
-Subjects receiving hormone replacement therapy.
-Subjects who are pregnant, may be pregnant, breastfeeding, or planning to become pregnant during the participation period.
-Subjects who have had significant sun exposure prior to the study date.
-Those currently participating in or planning to participate in other clinical trials that may affect the evaluation area.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Wakako |
| Middle name | |
| Last name | Inoue |
Organization
Yawara Dermatology Clinic
Division name
Dermatology
Zip code
530-0041
Address
Sakashin Tenjinbashi Building 4F, 5-7-10 Tenjinbashi, Kita-ku, Osaka City
TEL
06-6881-1000
ethics_board@drc-web.co.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Saitou |
Organization
POLA Chemical Industries,Inc.
Division name
Frontier Research Center
Zip code
244-0812
Address
560 Kashio-cho, Totsuka-ku, Yokohama
TEL
045-826-7231
Homepage URL
yu-saitou@pola.co.jp
Sponsor or person
Institute
DRC Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
POLA Chemical Industries Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
IWASE COSFA Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Brain Care Clinic Ethics Review Committee.
Address
Hakucho 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
東京Dクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 18 | 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 | 10 | Month | 29 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Compare gene expression between two areas of the face and the non-exposed area.
Management information
Registered date
| 2025 | Year | 11 | Month | 14 | Day |
Last modified on
| 2025 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068358
