UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059785 |
|---|---|
| Receipt number | R000068357 |
| Scientific Title | Beneficial Effects of Extracellular Vesicles derived from Bacillus coagulans lilac-01 on Human Skin Aging: A Randomized, Double-Blind, Placebo-Controlled Study |
| Date of disclosure of the study information | 2025/11/17 |
| Last modified on | 2025/11/14 16:58:14 |
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Basic information
Public title
Effects of application of the test product on the skin
Acronym
Effects of application of the test product on the skin
Scientific Title
Beneficial Effects of Extracellular Vesicles derived from Bacillus coagulans lilac-01 on Human Skin Aging: A Randomized, Double-Blind, Placebo-Controlled Study
Scientific Title:Acronym
Effects of application of the test product on the skin
Region
| Asia(except Japan) |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects on the skin of healthy adult men and women aged 40-65 who are aware of skin aging such as dryness and sagging by applying the test product to the skin for 4 weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin indicators such as skin moisture content, elasticity, firmness, collagen, dermis thickness, and skin color
Key secondary outcomes
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
Application of test product
Interventions/Control_2
Application of placebo
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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Male or female participants aged between 40 and 65 years.
2.Have not taken any oral skin-related dietary supplements within the past 6 months, such as collagen, hyaluronic acid, vitamin C, or other supplements claiming to improve skin condition.
3.Have not received any dermatologist-prescribed topical medication treatment within the past 2 months.
4.Agree to sign the image-use consent form and authorize the use of collected images for commercial purposes.
5.Fully understand all contents of the informed consent form and voluntarily agree to participate.
Key exclusion criteria
1.Have received any medical skin treatments (e.g., laser therapy, chemical peeling, etc.) within the past 2 months.
2.Currently or recently diagnosed with infectious or chronic skin diseases such as eczema or acne.
3.Pregnant, breastfeeding, planning to become pregnant, having heavy smoking or alcohol consumption habits, or currently participating in another clinical trial.
4.Direct employees of the entrusted testing organization, students enrolled in courses taught by the principal investigator, or students under the investigator' s academic supervision (e.g., thesis advising).
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tzu-Fang |
| Middle name | |
| Last name | Hsu |
Organization
Hung Kuang University
Division name
Department of Applied Cosmetology
Zip code
433304
Address
No. 1018, Sec. 6, Taiwan Boulevard, Shalu District, Taichung City 433304, Taiwan
TEL
+886-4-26318652
tzufang@hk.edu.tw
Public contact
Name of contact person
| 1st name | Kimiko |
| Middle name | |
| Last name | Minamida |
Organization
Arterio Bio Co., Ltd.
Division name
R&D Division
Zip code
047-0261
Address
519-11, 3-Chome, Zenibako, Otaru-shi, Hokkaido 0470261, Japan
TEL
0134-61-3301
Homepage URL
minamida@arterio.co.jp
Sponsor or person
Institute
Hung Kuang University
Institute
Department
Personal name
Funding Source
Organization
Hokkaido Bureau of Economy, Trade and Industry
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Arterio Bio Co., Ltd.
IRB Contact (For public release)
Organization
Institutional review board of Antai Medical Care Cooperation Antai Tian-Sheng Memorial Hospital
Address
No. 210, Sec. 1, Zhongzheng Rd., Donggang Township, Pingtung County 928004, Taiwan
Tel
+886-8-832-9966
tsmhirb2018@gmail.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
弘光科技大學/Hung Kuang University
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 17 | 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 | 10 | Month | 26 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 01 | 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 | 11 | Month | 14 | Day |
Last modified on
| 2025 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068357
