UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063116 |
|---|---|
| Receipt number | R000072249 |
| Scientific Title | Effects of a plant fermentation extract (260803) on UV-induced skin pigmentation |
| Date of disclosure of the study information | 2026/10/02 |
| Last modified on | 2026/09/30 13:19:51 |
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Basic information
Public title
Effects of a plant fermentation extract (260803) on UV-induced skin pigmentation
Acronym
Effects of a plant fermentation extract (260803) on UV-induced skin pigmentation
Scientific Title
Effects of a plant fermentation extract (260803) on UV-induced skin pigmentation
Scientific Title:Acronym
Effects of a plant fermentation extract (260803) on UV-induced skin pigmentation
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the inhibitory effect of topical application of the test formulation on UV-induced skin pigmentation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin color measurement (L* value)
Key secondary outcomes
Skin color measurement (a* value)
Stratum corneum hydration
Transepidermal water loss
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
The test product will be applied to the designated test site three times daily for 43 days
Interventions/Control_2
The placebo product will be applied to the designated test site three times daily for 43 days
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
| 54 | years-old | >= |
Gender
Female
Key inclusion criteria
1.Participants who provided written informed consent after receiving and understanding an explanation of the study
2.Healthy Japanese female aged 20 to 54 years at the time of informed consent
3.Participants capable of completing study-related documents, including the informed consent form and study diary
4.Participants able to attend the designated study facility on the day of measurement
Key exclusion criteria
1.Participants with wounds, acne, eczema, or other skin conditions at the test site
2.Participants with excessive sunburn at the test site
3.Participants using cosmetics, quasi-drugs, or medications that may affect study outcomes
4.Participants who had regularly used medications containing tranexamic acid, vitamin C, or L-cysteine within 3 months prior to study initiation
5.Participants unable to discontinue Foods with Function Claims for skin improvement during the study
6.Participants currently consuming, or having consumed within 3 months, Foods with Function Claims containing fermented rice bran
7.Participants who regularly attend tanning or beauty salons, or plan to do so during the study
8.Participants likely to have excessive sun exposure during the study (e.g., frequent outdoor sports)
9.Participants with a history of allergic reactions to cosmetics or related products
10.Participants with skin disorders, including atopic dermatitis
11.Participants with severe hay fever requiring medication
12.Participants consuming 20 g/day or more of pure alcohol
13.Participants with a smoking habit, including e-cigarette use
14.Participants with a history of serious hepatic, renal, cardiovascular, psychiatric, or other severe diseases
15.Participants who are pregnant, breastfeeding, or planning pregnancy during the study
16.Participants who participated in another clinical trial within 3 months or are currently participating in another trial
17.Participants receiving medical treatment or regular outpatient care for any disease, excluding dental treatment
18.Participants currently using medications for any disease
19.Participants related to this study, including those affiliated with the sponsor or contract research organizatio
20.Participants who themselves, or whose family members, work for a pharmaceutical or cosmetic company
21.Participants deemed unsuitable by the investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoshihito |
| Middle name | |
| Last name | Kawashima |
Organization
Maruzen Pharmaceuticals Co., Ltd.
Division name
Research & Development Division
Zip code
729-3102
Address
1089-8 Sagata, Shin-ichi, Fukuyama City, Hiroshima, Japan
TEL
0847-52-5501
y-kawashima@maruzenpcy.co.jp
Public contact
Name of contact person
| 1st name | Kanako |
| Middle name | |
| Last name | Sakurai |
Organization
Infoward Co., Ltd.
Division name
Ebisu Skin Research Center
Zip code
150-0013
Address
5th Floor, Sankei 51 Building, 1-11-2 Ebisu, Shibuya-ku, Tokyo, Japan
TEL
03-5793-8712
Homepage URL
sakurai@inforward.co.jp
Sponsor or person
Institute
Maruzen Pharmaceuticals Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Maruzen Pharmaceuticals Co., Ltd.
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
General Incorporated Association Clinical Research Review Center
Address
2972-8-603, Ishikawamachi, Hachioji City, Tokyo, Japan
Tel
090-3547-6398
crrctakashima@kpd.biglobe.ne.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 | 10 | Month | 02 | 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 | 08 | Month | 27 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 17 | 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 | 09 | Month | 30 | Day |
Last modified on
| 2026 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072249
