UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063222 |
|---|---|
| Receipt number | R000072363 |
| Scientific Title | Anti-aging effects of ERALIUM cosmetics with nanoPDS containing NMN on skin: an open-label study |
| Date of disclosure of the study information | 2026/10/08 |
| Last modified on | 2026/10/08 17:34:46 |
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Basic information
Public title
Anti-aging effects of ERALIUM cosmetics with nanoPDS containing NMN on skin: an open-label study
Acronym
Anti-aging effects of ERALIUM cosmetics with nanoPDS containing NMN on skin: an open-label study
Scientific Title
Anti-aging effects of ERALIUM cosmetics with nanoPDS containing NMN on skin: an open-label study
Scientific Title:Acronym
Anti-aging effects of ERALIUM cosmetics with nanoPDS containing NMN on skin
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the anti-aging effects of ERALIUM cosmetics with nanoPDS containing NMN on skin.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Skin condition, transepidermal water loss (TEWL), and stratum corneum hydration
Key secondary outcomes
1. Questionnaire
2. Incidence of adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Duration: 8 weeks
Test product: ERALIUM cosmetics with nanoPDS containing NMN and control cosmetics
Administration: Once every morning, apply an appropriate amount of ERALIUM SpaceTime Gel Essence followed by ERALIUM SpaceTime Oil Serum to the left side of face, and apply an appropriate amount of the control products (lotion followed by serum) to the right side of face.
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
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Japanese
2. Women
3. Individuals aged between 40 and 60
4. Healthy individuals
5. Individuals who have not used ERALIUM cosmetics with nanoPDS containing NMN
6. Individuals who are judged as eligible to participate in the study by the physician
Key exclusion criteria
Individuals (who)
1.have factors on the evaluation site that may affect the results
2.have had cosmetic treatments on the evaluation site, or plan to have them during this study
3.have received special skincare treatments on the evaluation site within the past 4 weeks, or plan to receive them during this study
4.continuously use skin care products, cosmetics, quasi-drugs, or health foods that claim or emphasize effects or benefits that are similar to or related to the efficacy evaluated in this study on the evaluation site
5.have changed or started using new health supplements, basic skincare products, or sunscreen on the evaluation site within the past 4 weeks
6.have had excessive UV rays beyond daily life within the past 4 weeks, or plan to do during this study
7.are late-night shift workers or shift workers
8.receive treatment at medical institutions for the treatment or prevention of diseases or are determined to require treatment at the time of agreement to participate in this study
9.have a history of severe diseases: carbohydrate metabolism, lipid metabolism, liver function, kidney function, the heart, circulatory system, respiratory system, endocrine system, immune system, or nervous system, or a history of psychiatric disorder
10.have a history of alcohol or drug dependence
11.have risk of developing allergies to cosmetics or foods
12.are pregnant, or lactating at the time of agreement to participate in this study, planning to become pregnant during this study
13.are pregnant, or lactating
14.have a history of allergy due to using cosmetics
15.have undergone cosmetic medical procedures that may affect the evaluation site
16.with inflammation or skin disease on the observation site
17.have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate another study during this study
18.are deemed unsuitable for participation in this study by the principal investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Uto |
Organization
national university corporation Tokushima University
Division name
Graduate School of Technology, Industrial and Social Science, Tokushima University
Zip code
770-8506
Address
2-1, Minamijosanjima-cho, Tokushima city, Tokushima, Japan
TEL
088-656-7514
uto.yoshihiro@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Madoka |
| Middle name | |
| Last name | Kato |
Organization
Mitsuashi Enterprise
Division name
Headquarters
Zip code
105-0004
Address
7F BUREX FIVE, 2-11-10, Shinbashi, Minato-ku, Tokyo, Japan
TEL
080-1426-2562
Homepage URL
m-kato@mitsuashi-media.com
Sponsor or person
Institute
national university corporation Tokushima University
Institute
Department
Personal name
Funding Source
Organization
national university corporation Tokushima University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Mitsuashi Enterprise
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
Tel
03-5793-3623
IRB@takara-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
桜川よしえクリニック (大阪府)
yoshie sakuragawa clinic (Osaka, Japan)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 10 | Month | 07 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 25 | 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 | 10 | Month | 08 | Day |
Last modified on
| 2026 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072363
