UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060092 |
|---|---|
| Receipt number | R000068614 |
| Scientific Title | Effect of the test food on skin elasticity -a randomized, double-blind, placebo-controlled, parallel-group study- |
| Date of disclosure of the study information | 2025/12/15 |
| Last modified on | 2025/12/15 19:55:15 |
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Basic information
Public title
Effect of the test food on skin elasticity -a randomized, double-blind, placebo-controlled, parallel-group study-
Acronym
Effect of the test food on skin elasticity
Scientific Title
Effect of the test food on skin elasticity -a randomized, double-blind, placebo-controlled, parallel-group study-
Scientific Title:Acronym
Effect of the test food on skin elasticity
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of test food intake on skin elasticity.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin elasticity
Key secondary outcomes
Transepidermal water loss (TEWL), Stratum corneum water content, VISIA image analysis, Skin color /tone (spectrophotometer), Subjective skin condition assessments (SS-10, VAS)
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
Intake of test food for 8 weeks
Interventions/Control_2
Intake of placebo food for 8 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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
(1) Japanese women aged 30-59 years at the time of consent.
(2) Individuals who feel dryness and decreased firmness or elasticity of the skin.
(3) Individuals who received sufficient explanation about the study and voluntarily provided written informed consent.
Key exclusion criteria
(1) Individuals with a history or current diagnosis of chronic diseases such as liver disease, kidney disease, diabetes, or skin disease, or those currently receiving medical treatment or medication.
(2) Individuals with a history of atopic dermatitis or an atopic predisposition.
(3) Individuals who have received cosmetic medical or surgical treatments at the evaluation site within the past 6 months, or plan to do so during the study.
(4) Individuals who have received beauty treatments, massages, or peeling at the evaluation site within the past 4 weeks, or plan to do so during the study.
(5) Individuals who have developed a skin disorder at the evaluation site and received treatment within the past 4 weeks, or plan to do so during the study.
(6) Individuals who continuously use medications, quasi-drugs, health foods, dietary supplements, skincare products, or beauty devices that may affect the study results.
(7) Individuals who have been exposed to excessive ultraviolet light within the past 4 weeks, or plan such exposure during the study.
(8) Individuals with a history of excessive alcohol consumption, drug dependence, or mental illness.
(9) Individuals who smoke regularly.
(10) Individuals with irregular lifestyles due to shift work or sleep disorders.
(11) Individuals with a risk of allergy to the test food.
(12) Individuals who may use medications for seasonal allergies or who have symptoms of skin irritation during the study.
(13) Individuals who plan to change their mask-wearing habits during the study.
(14) Individuals who are pregnant or breastfeeding, or who wish to become pregnant during the study.
(15) Individuals who plan overseas travel, domestic trips, or changes in living environment lasting one week or longer during the study.
(16) Individuals who have participated in another clinical study within the past 4 weeks.
(17) Any other individuals deemed inappropriate by the principal investigator.
Target sample size
88
Research contact person
Name of lead principal investigator
| 1st name | Wakako |
| Middle name | |
| Last name | Inoue |
Organization
YAWARA Dermatology Clinic
Division name
Director
Zip code
530-0041
Address
Sakashin Tenjinbashi Building 4F, 5-7-10 Tenjinbashi, Kita-ku, Osaka, Japan
TEL
06-6881-1000
drc_shokuhin@drc-web.co.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Furusho |
Organization
DRC Co., Ltd.
Division name
Clinical Trial Group, Testing Department
Zip code
530-0044
Address
5th Floor, Dai-9 Tabuchi Building, 2-10-31 Higashi-Tenma, Kita-ku, Osaka, Japan
TEL
06-6882-1130
Homepage URL
furusyo@drc-web.co.jp
Sponsor or person
Institute
DRC Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
FANCL Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Brain Care Clinic Ethics Review Committee
Address
Hakutyo Build. 2F,2-1-2 Shinjuku,Shinjuku-ku, Tokyo
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
DRC株式会社 東京評価センター/東京Dクリニック（東京都）
DRC Co., Ltd. Tokyo evaluation center / Tokyo D Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 15 | 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 | 11 | Month | 13 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 08 | 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 | 12 | Month | 15 | Day |
Last modified on
| 2025 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068614
