UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062021 |
|---|---|
| Receipt number | R000070972 |
| Scientific Title | Evaluation of the effects of continuous use of test products on skin condition |
| Date of disclosure of the study information | 2026/06/23 |
| Last modified on | 2026/06/23 11:02:45 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of the effects of continuous use of test products on skin condition
Acronym
Evaluation of the effects of continuous use of test products on skin condition
Scientific Title
Evaluation of the effects of continuous use of test products on skin condition
Scientific Title:Acronym
Evaluation of the effects of continuous use of test products on skin condition
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of continuous use of test products on skin condition
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in skin condition parameters following intervention (measured values and images)
Key secondary outcomes
Changes in skin condition parameters following intervention (absolute changes and percentage changes)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Continuous use of the test products
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
| 22 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Men or women
2. Adults (aged 22 to 59)
3. Healthy individuals
Key exclusion criteria
1. Individuals with severe skin conditions, such as dermatitis
2. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction
3. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)
4. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, metabolic bone disorders, including osteoporosis and fractures, or any other chronic diseases
5. Individuals who are unable to avoid intentional sun exposure, such as sunbathing, during the study period
6. Individuals with known allergies to medications or test-related substances
7. Individuals who have a present condition or have a medical history of drug or alcohol dependence
8. Individuals who are pregnant, lactating, or planning to become pregnant during this study
9. Individuals who currently or within the past month have a habit of continuous oral intake or topical application of drugs claiming skin improvement benefits, or who are otherwise judged by the principal investigator to be inappropriate for this study
10. Individuals who are using cosmetics with strong moisturizing or anti-wrinkle effects
11. Individuals who are judged as ineligible to participate in this study by the physician
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kazuya |
| Middle name | |
| Last name | Watabe |
Organization
Pharma Foods International Co., Ltd.
Division name
R&D Department
Zip code
615-8245
Address
1-49, Goryohara, Nishikyo-ku, Kyoto-shi, Kyoto, Japan
TEL
075-748-9829
watabe@pharmafoods.co.jp
Public contact
Name of contact person
| 1st name | Saki |
| Middle name | |
| Last name | Shirako |
Organization
Pharma Foods International Co., Ltd.
Division name
R&D Department
Zip code
615-8245
Address
1-49, Goryohara, Nishikyo-ku, Kyoto-shi, Kyoto, Japan
TEL
075-748-9829
Homepage URL
saki-shirako@pharmafoods.co.jp
Sponsor or person
Institute
Pharma Foods International Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Client
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Thailand
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation DiaStep Ouchinodoctor Research Ethics Committee
Address
Morizumi Bldg. 3F, 4-22-7 Taishido, Setagaya-ku, Tokyo, 154-0004, Japan
Tel
03-5433-3255
tomohisa.kato@diastep.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
株式会社ファーマフーズ (京都府)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 23 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 25 | 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
| 2026 | Year | 06 | Month | 23 | Day |
Last modified on
| 2026 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070972
