UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060207 |
|---|---|
| Receipt number | R000068824 |
| Scientific Title | Clinical study of the combined effect of laser treatment and NMN intake on removing aging spots |
| Date of disclosure of the study information | 2025/12/25 |
| Last modified on | 2025/12/25 11:53:18 |
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Basic information
Public title
Clinical study of the combined effect of laser treatment and NMN intake on removing aging spots
Acronym
Clinical study of the combined effect of laser treatment and NMN intake on removing aging spots
Scientific Title
Clinical study of the combined effect of laser treatment and NMN intake on removing aging spots
Scientific Title:Acronym
Clinical study of the combined effect of laser treatment and NMN intake on removing aging spots
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluating the effectiveness of NMN supplementation on laser treatment for aging spots.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Color difference measurement: Change in L value
Image verification: Downtime (number of days until redness/scabbing), Post-inflammatory hyperpigmentation (PIH) incidence rate
Subjective skin condition
Key secondary outcomes
Image Verification: Visual Assessment Score
Blood Test: NAD+ Blood Levels, Blood Markers (Blood GSH Levels, etc.)
Subjective Assessment (Skindex 29)
VAS (Pain/Discomfort After Laser Treatment, Patient Satisfaction, Skin Quality, Fatigue, Sleep, etc.)
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
| Food |
Interventions/Control_1
Phase1(Control Food),Washout,Phase2(Test Food)
Interventions/Control_2
Phase1(Test Food),Washout,Phase2(Control Food)
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
| 35 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Individuals who have received a full explanation of the purpose and content of this study,are competent to consent,fully understand the content,voluntarily volunteer to participate,and can provide written consent to participate in this study.
2.Men and women aged 35 years or older at the time of consent.
3.Individuals deemed appropriate for participation in this study by the principal investigator.
4.From among those who meet the above criteria,priority will be given to individuals concerned about skin aging spots (those deemed appropriate for this study by the principal investigator after reviewing images of the applicant's aging spots).
Key exclusion criteria
1.Subjects with a current or past serious illnesses,including brain disease,malignant tumors,immune disorders,diabetes,liver disease (hepatitis),liver damage,kidney disease,heart disease,thyroid disease,adrenal gland disease,or other metabolic disorders.
2.Subjects currently undergoing treatment for psychiatric disorders,including sleep disorders (insomnia) and depression.
3.Subjects who may have allergic reactions to the test food (vitamins),supplements,and ingredients in the test food and placebo foods,as well as to other foods and medications.
4.Subjects who are not using topical preparations or foods (including those containing NMN or N-methyl-N ... Individuals who are unable to refrain from using or consuming any of the following substances from two weeks prior to or during the study: D+ precursors,niacin (vitamin B3,nicotinamide,nicotinamide), glutathione,cysteine,yeast extract,vitamin C,vitamin E,vitamin A (retinol),tretinoin,placenta,hyaluronic acid,collagen,astaxanthin,xanthophyll,lycopene,beta-carotene,procyanidins,collagen peptides,heparinoids,etc.
5.Individuals currently participating in other clinical trials,those who have participated in other clinical trials within the past three months,or those who may undergo any of the above-mentioned tests or procedures during this study period.
6.Individuals who have difficulty completing various questionnaires.
7.Individuals who are pregnant,planning to become pregnant,or breastfeeding.
8.Subjects who have experienced severe sunburn within the past month.
9.Subjects with keloid tendencies,photosensitivity,or taking photosensitizing medications (e.g., tetracycline).
10.Subjects who have received treatment for skin aging spots (including laser treatment) within the past three months.
11.Subjects receiving immunosuppressive therapy.
12.Subjects who are otherwise deemed unsuitable by the investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Fujimoto |
Organization
Clinic F
Division name
Director
Zip code
102-0093
Address
1-8-12 Hirakawa-cho Chiyoda-ku,Tokyo 102-0093 Japan
TEL
03-3221-6461
fujimoto01@gmail.com
Public contact
Name of contact person
| 1st name | Shuichi |
| Middle name | |
| Last name | Fukumoto |
Organization
Mitsubishi Corporation Life Sciences Limited
Division name
New Product Development Group Nutrition Business Division
Zip code
100-6605
Address
1-9-2 Marunouchi,chiyoda-ku,Tokyo 100-6605 Japan
TEL
03-6386-0750
Homepage URL
shuichi.fukumoto@mcls-ltd.com
Sponsor or person
Institute
Mitsubishi Corporation Life Sciences Limited
Institute
Department
Personal name
Funding Source
Organization
Mitsubishi Corporation Life Sciences Limited
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
C&C Inc.
Address
1-7-6 Higashigotanda,Sinagawa-ku,Tokyo 141-0022 Japan
Tel
03-6431-8761
nanbu@candc.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
クリニックＦ（東京都）
三菱商事ライフサイエンス株式会社（東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 25 | 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 | 12 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 07 | 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 | 12 | Month | 25 | Day |
Last modified on
| 2025 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068824
