UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063617 |
|---|---|
| Receipt number | R000072769 |
| Scientific Title | A Study on the Effects of Food Consumption Following Skincare with Niacinamide-Containing Formulations on Facial Skin Condition |
| Date of disclosure of the study information | 2026/11/13 |
| Last modified on | 2026/11/13 08:23:41 |
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Basic information
Public title
A Study on the Effects of Food Consumption Following Skincare with Niacinamide-Containing Formulations on Facial Skin Condition
Acronym
A Study on the Effects of Food Consumption Following Skincare with Niacinamide-Containing Formulations on Facial Skin Condition
Scientific Title
A Study on the Effects of Food Consumption Following Skincare with Niacinamide-Containing Formulations on Facial Skin Condition
Scientific Title:Acronym
A Study on the Effects of Food Consumption Following Skincare with Niacinamide-Containing Formulations on Facial Skin Condition
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A Study on the Effects of Food Consumption Following Skincare with Niacinamide-Containing Formulations on Facial Skin Condition
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
*RoboSkin Analyzer (pores, pigmentation, wrinkles, skin texture)
*Moisture Level
*Oil Level
*Log
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food | Other |
Interventions/Control_1
Test food
Test serum
Interventions/Control_2
No intake
Test serum
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Individuals who routinely perform post-cleansing skincare using basic skincare products (such as toner)
(2) Individuals with no abnormalities in their temporomandibular joints or teeth who are able to follow the prescribed diet as directed (3) Individuals who have received a thorough explanation of the purpose and content of this study, have fully understood the details, have volunteered to participate of their own free will, and have provided written consent to participate in this study
Key exclusion criteria
(1) Individuals with dental or oral surgical conditions-such as temporomandibular joint disorder, severe dental caries (cavities), or ill-fitting dentures-that would interfere with the consumption of the test food
(2) Individuals who cannot refrain from changing their current basic skincare products or adding new skincare products or beauty devices during the trial period
(3) Individuals with a history of allergies or hypersensitivity to the test formulation (e.g., niacinamide) or any ingredients in the designated test food
(4) Individuals who plan to undergo cosmetic medical procedures on the face (e.g., laser treatment, chemical peels) or engage in activities involving excessive sun exposure during the trial period
(5) Individuals who are pregnant, breastfeeding, or planning to become pregnant during the trial period
(6) Individuals with severe atopic dermatitis, acne vulgaris (acne), contact dermatitis, or other skin conditions on the face, or skin lesions that may affect the trial evaluation
(7) Individuals who currently use, or have used within the past two weeks, skincare products containing high concentrations of niacinamide on a daily basis
(8) Any other individuals deemed unsuitable as trial participants by the principal investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kazuto |
| Middle name | |
| Last name | Okabayashi |
Organization
Lotte Co., Ltd.
Division name
Central Laboratory, Kamukoto Research Department
Zip code
3368601
Address
1-1, Numakage-3chome, Minami-ku, Saitama
TEL
048-837-0744
okabayashi_kazuto@lotte.co.jp
Public contact
Name of contact person
| 1st name | Kazuto |
| Middle name | |
| Last name | Okabayashi |
Organization
Lotte Co., Ltd.
Division name
Central Laboratory, Kamukoto Research Department
Zip code
3368601
Address
1-1, Numakage-3chome, Minami-ku, Saitama
TEL
048-837-0744
Homepage URL
okabayashi_kazuto@lotte.co.jp
Sponsor or person
Institute
Lotte Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Lotte Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic
Address
6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
Tel
03-5408-1590
jimukyoku@mail.souken-r.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 11 | Month | 13 | 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 | 10 | Month | 16 | Day |
Date of IRB
| 2026 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 13 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2026 | Year | 11 | Month | 13 | Day |
Last modified on
| 2026 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072769
