UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061588 |
|---|---|
| Receipt number | R000070466 |
| Scientific Title | Effects of the test product on skin condition |
| Date of disclosure of the study information | 2026/05/15 |
| Last modified on | 2026/05/15 15:47:55 |
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Basic information
Public title
Effects of the test product on skin condition
Acronym
Effects of the test product on skin condition
Scientific Title
Effects of the test product on skin condition
Scientific Title:Acronym
Effects of the test product on skin condition
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effects of the test product on skin condition will be evaluated using a placebo as a control.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin appearance
Key secondary outcomes
Skin dryness
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Use Test Item once daily for 8 consecutive weeks
Interventions/Control_2
Use Control Product once daily for 8 consecutive weeks
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
| 30 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy men and women aged 30 to 64
(2) Individuals who are aware of dry skin and the associated changes in appearance
(3) Individuals who fully understand the purpose and details of the study and consent to participate of their own free will
Key exclusion criteria
(1) Individuals who have undergone cosmetic treatments that may affect the measurement site (e.g., Botox injections, hyaluronic acid injections, collagen injections, etc.)
(2) Individuals who have undergone, or plan to undergo, skin treatments such as facials, body scrubs, or hair removal on the skin of the measurement site between 4 weeks prior to the pre-screening and the end of the study
(3) Individuals who have been, or plan to be, sunburned due to prolonged outdoor work, leisure activities, exercise, etc., between 4 weeks prior to the pre-screening and the end of the study
(4) Individuals who have consumed, or plan to consume, health supplements or medications containing high levels of ceramides, proteoglycans, or placenta at least once a week between 4 weeks prior to the preliminary examination and the end of the study
(5) Individuals at risk of developing an allergy to the test product
(6) Individuals deemed unsuitable as subjects based on the results of the lifestyle questionnaire
(7) Individuals deemed unsuitable as subjects based on the results of the preliminary examination
(8) Other individuals deemed unsuitable as subjects at the discretion of the principal investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tatsuji |
| Middle name | |
| Last name | Takahashi |
Organization
ICHIMARU PHARCOS Co., Ltd.
Division name
Research and Development Division
Zip code
501-0475
Address
318-1 Asagi, Motosu-Shi, Gifu
TEL
058-320-1030
support@ichimaru.co.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Nakagawa |
Organization
EP Mediate Co., Ltd.
Division name
Development Department
Zip code
162-0814
Address
Acropolis TOKYO, 6-29 Shin-ogawamachi, Shinjuku-ku, Tokyo
TEL
080-7710-1146
Homepage URL
nakagawa.takashi768@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
ICHIMARU PHARCOS 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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo
Tel
03-6452-2712
epmd_fd-erb@eps.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
株式会社ビューティアンドヘルスリサーチ（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 15 | 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 | 05 | Month | 14 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 18 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 15 | Day |
Last modified on
| 2026 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070466
