UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055430 |
|---|---|
| Receipt number | R000063345 |
| Scientific Title | Confirmation study on the skin-improving effects of tomato seed extract intake: A randomized, double-blind, placebo-controlled, parallel-group study |
| Date of disclosure of the study information | 2024/09/05 |
| Last modified on | 2024/09/05 14:47:31 |
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Basic information
Public title
Confirmation study on the skin-improving effects of plant extract intake
Acronym
Confirmation study on the skin-improving effects of plant extract intake
Scientific Title
Confirmation study on the skin-improving effects of tomato seed extract intake: A randomized, double-blind, placebo-controlled, parallel-group study
Scientific Title:Acronym
Confirmation study on the skin-improving effects of plant extract intake
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirmation study on changes in skin texture from plant extract intake
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Wrinkle evaluation
Key secondary outcomes
Measurement of skin conditions (DermaLab, VISIA-Evolution,questionnaire)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take supplements containing plant extracts for 12 weeks.
Interventions/Control_2
Take placebo supplements for 12 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
| 40 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Female
Key inclusion criteria
1.Individuals concerned about crow's feet wrinkles.
2.Individuals who perceive a lack of firmness or elasticity in their facial skin.
3.Individuals able to consume the test product as directed during the study period.
4.Individuals who agree not to change or add to their current skincare products during the study period.
5.Individuals who agree to avoid excessive sun exposure and dieting during the study period.
Key exclusion criteria
1. Individuals with food allergies.
2. Individuals who are breastfeeding, pregnant, or planning to become pregnant during the study period.
3. Individuals who have received cosmetic medical treatments on the face within the past year or plan to do so during the study period.
4. Individuals currently experiencing moderate to severe atopic dermatitis symptoms, or those using topical treatments frequently on the entire face for atopic dermatitis.
5. Individuals with skin diseases, allergies, or other conditions that may worsen by participating in the study.
6. Individuals with noticeable spots, moles, or birthmarks on the face.
7. Individuals with severe sunburns or those who cannot avoid prolonged outdoor activities or sports.
8. Individuals with a history of major gastrointestinal surgery, or those with respiratory or cardiac disorders.
9. Individuals undergoing or who have undergone hormone replacement therapy for menopausal disorders, unless more than 6 months have passed since the treatment.
10. Individuals who regularly use medications, quasi-drugs, supplements, or health foods that may affect the outcome of the study (e.g., vitamins, hormones, or products claiming skin benefits).
11. Smokers, habitual alcohol consumers, or individuals with extremely irregular eating habits.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Koikeda |
Organization
Shiba Palace Clinic
Division name
Hospital director
Zip code
105-0013
Address
6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL
03-5408-1599
jimukyoku@mail.souken-r.com
Public contact
Name of contact person
| 1st name | Miwa |
| Middle name | |
| Last name | Kaneko |
Organization
SOUKEN Co., Ltd
Division name
Management Division
Zip code
105-0013
Address
3F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL
03-5406-1555
Homepage URL
m_kaneko@mail.souken-r.com
Sponsor or person
Institute
Shiba Palace Clinic
Institute
Department
Personal name
Funding Source
Organization
POLA INC.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
Tel
03-5408-1590
shiba_palace@s-palace-clinic.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 05 | 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
45
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
Completed
Date of protocol fixation
| 2023 | Year | 08 | Month | 04 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 04 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 14 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 14 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 05 | Day |
Last modified on
| 2024 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063345
