UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058655 |
|---|---|
| Receipt number | R000067058 |
| Scientific Title | Examination of the effect of continuous intake of lactic acid bacteria on skin damage induced by ultraviolet (UV). |
| Date of disclosure of the study information | 2025/09/01 |
| Last modified on | 2025/07/31 13:58:59 |
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Basic information
Public title
Examination of the effect of continuous intake of lactic acid bacteria on skin damage induced by ultraviolet (UV).
Acronym
Examination of the effect of continuous intake of lactic acid bacteria on skin damage induced by ultraviolet (UV).
Scientific Title
Examination of the effect of continuous intake of lactic acid bacteria on skin damage induced by ultraviolet (UV).
Scientific Title:Acronym
Examination of the effect of continuous intake of lactic acid bacteria on skin damage induced by ultraviolet (UV).
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to consider the effect of whether ingestion of test food suppress skin damage after ultraviolet (UV) radiation in healthy subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MED (Minimal Erythema Dose)
Key secondary outcomes
Skin color measurement (L-value, a-value) by spectrophotometer
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
| Food |
Interventions/Control_1
Take 2 tablets of test foods with water once a day for 13 weeks.
Interventions/Control_2
Take 2 tablets of placebo foods with water once a day for 13 weeks.
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Male and Female between 20 and 59 years old of age at the time of obtaining consent to participate in the study.
2.Individuals who have Fitzpatrick skin phototype 2 or 3.
3.Those whose back skin allows for the evaluation of UV-induced erythema.
4.Those whose MED is determined to correspond to the 2nd, 3rd, 4th, or 5th level in the 6-step UV irradiation performed prior to the intake of the test product.
5.Those who are able to visit the study site on all scheduled study days.
6.Those who have received sufficient explanation about the purpose and details of the study, have the capacity to consent, fully understand the study, voluntarily agree to participate, and provide written informed consent.
Key exclusion criteria
1.Those who smoke.
2.Those who have been diagnosed with photosensitivity.
3.Those who taking drugs that may affect the photosensitivity of the skin.
4.Those who have any factors on the evaluation site that may affect the study results.
5.Those who have a history or current diagnosis of atopic dermatitis, or who have an atopic predisposition.
6.Those who have received or plan, to receive cosmetic treatment on the evaluation site during the study period.
7.Those who have received skincare treatments within 4 weeks, or plan to receive them during the study period.
8.Those who consume foods or supplements including high lactic acid bacteria or natto bacteria.
9.Those who regularly use body creams, lotions, or other skincare products on the evaluation site.
10.Those who regularly use basic skincare products or health foods containing vitamin C on the evaluation site.
11.Those who continuously use skincare products, cosmetics, quasi-drugs, or health foods.
12.Those who are continuously taking pharmaceuticals that claim efficacy for pigmentation.
13.Those who have changed or started using health foods or basic cosmetics within 4 weeks.
14.Those who expressed to UV beyond daily life within 4 weeks, or planning such exposure during the study.
15.Those who work night shifts or rotating day/night shifts.
16.Those who receiving or needing medical care for disease/prevention when consenting.
17.Those who use anti-inflammatory drugs (including pain relievers) continuously at least once per month.
18.Those who have a history of serious disorders.
19.Those who have a history of alcohol or drug dependence.
20.Those who may have allergic reactions to cosmetics or food products.
21.Those who are pregnant, breastfeeding, or intending to become pregnant during the study period.
22.Those who participated in other study within 4 weeks, or plan to participate during this study period.
23.Those deemed unsuitable for trail participation by the principal investigator.
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Higuchi |
Organization
KAMEDA SEIKA CO., LTD.
Division name
Rice Research Institute
Zip code
950-0198
Address
3-1-1 Kameda-kogyodanchi, Konan-ku, Niigata-shi, Niigata, Japan
TEL
025-382-8879
y_higuchi@sk.kameda.co.jp
Public contact
Name of contact person
| 1st name | Yuhma |
| Middle name | |
| Last name | Yoshida |
Organization
DRC CO., LTD.
Division name
Efficacy Testing of Cosmetics and Foods Groups
Zip code
530-0044
Address
Tabuchi Bldg. No.9 5F, 2-10-31, Higashi-Temma, Kita-ku, Osaka 530-0044, Japan
TEL
06-6882-1130
Homepage URL
yoshida@drc-web.co.jp
Sponsor or person
Institute
DRC CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
KAMEDA SEIKA 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
Brain Care Clinic Ethics Review Committee.
Address
Shiratori Build 2F, 2-1-2 Shinjyuku, Shinjyuku-ku, Tokyo 160-0022, Japan
Tel
06-6882-1130
ethics_board@drc-web.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
| 2025 | Year | 09 | Month | 01 | 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 | 07 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2025 | Year | 07 | Month | 31 | Day |
Last modified on
| 2025 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067058
