UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060461 |
|---|---|
| Receipt number | R000069163 |
| Scientific Title | Epidemiological Study Using Test Products |
| Date of disclosure of the study information | 2026/01/26 |
| Last modified on | 2026/01/23 16:52:26 |
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Basic information
Public title
Epidemiological Study Using Test Products
Acronym
Epidemiological Study Using Test Products
Scientific Title
Epidemiological Study Using Test Products
Scientific Title:Acronym
Epidemiological Study Using Test Products
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effects of using the test product on skin condition and deep tissue structure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
[Lip]stratum corneum moisture content, transepidermal water loss, skin viscoelasticity, dermal thickness, skin pH, stratum corneum condition, morphological evaluation via image analysis, internal structural changes via image analysis
[Face]changes in skin condition indicators such as pigmentation, wrinkles, and pores
Key secondary outcomes
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
Use once a day or more for one month.
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Female
Key inclusion criteria
(1) Individuals who participated in the pre-trial and were in their 20s, 40s, or 60s at the time of obtaining consent for the pre-trial
(2) Females
(3) Individuals who have received sufficient explanation regarding the purpose and content of the main trial, possess the capacity to consent, have fully understood the information, voluntarily applied to participate, and are able to provide written consent to participate in the main trial
Key exclusion criteria
(1)deemed ineligible for internal structure examinations by medical institutions.
(2)factors on the evaluation site skin that may affect test results.
(3)history or current condition of atopic dermatitis, or those with an atopic predisposition.
(4)undergone cosmetic medical procedures on the evaluation site, or who plan to undergo such procedures during the test period
(5)received special skincare treatments on the evaluation site within the past 4 weeks, or who plan to receive such treatments during the test period
(6)routinely apply pharmaceuticals or topical medications to the evaluation site
(7)changed or newly started using health supplements, basic cosmetics applied to the evaluation site, or sunscreen within the past 4 weeks
(8)exposed to ultraviolet rays beyond their normal daily activities within the past 4 weeks, or who plan to do so during the trial period
(9)working night shifts or rotating day-night shifts
(10)receiving treatment at medical institutions for disease treatment or prevention at the time of consent acquisition, or individuals judged to be in a condition requiring treatment
(11)history of serious diseases affecting glucose metabolism, lipid metabolism, liver function, kidney function, the circulatory system, respiratory system, endocrine system, immune system, or nervous system
(12)history of alcohol or drug dependence
(13)risk of developing allergies to cosmetics or food (including those who experienced skin abnormalities such as rashes from cosmetics within the past year)
(14)pregnant or breastfeeding at the time of consent acquisition,wish to become pregnant during the trial period
(15)participated in another human trial within the past 4 weeks, or who plan to participate in another human trial during the scheduled period of this trial
(16)silver fillings or dental implants
(17)deemed unsuitable for trial participation by the Principal Investigator (or Investigator)
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | Yukiko |
| Middle name | |
| Last name | Ishitsuka |
Organization
DHC Corporation
Division name
Fragrance and Cosmetics Unit
Zip code
108-0023
Address
2-7-1 Shibaura, Minato-ku, Tokyo
TEL
03-5765-9518
yshinmoto@dhc.co.jp
Public contact
Name of contact person
| 1st name | Junichiro |
| Middle name | |
| Last name | Nagumo |
Organization
DHC Corporation
Division name
Fragrance and Cosmetics Unit
Zip code
108-0023
Address
2-7-1 Shibaura, Minato-ku, Tokyo
TEL
03-5765-9518
Homepage URL
jnagumo@dhc.co.jp
Sponsor or person
Institute
DHC Corporation
Institute
Department
Personal name
Funding Source
Organization
DHC Corporation
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
DHC Ethics Review Committee
Address
2-7-1, Minamiazabu, Minato-ku, Tokyo
Tel
N/A
ml-ethicsoffice@dhc.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 26 | 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 | 01 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2026 | 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 | 01 | Month | 25 | Day |
Last modified on
| 2026 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069163
