UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057652 |
|---|---|
| Receipt number | R000065856 |
| Scientific Title | A study to evaluate the effects of food containing plant-derived ingredients on the skin condition (g2024007) |
| Date of disclosure of the study information | 2025/04/25 |
| Last modified on | 2025/04/18 16:30:16 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study to evaluate the effects of food containing plant-derived ingredients on the skin condition (g2024007)
Acronym
A study to evaluate the effects of food on the skin condition (g2024007)
Scientific Title
A study to evaluate the effects of food containing plant-derived ingredients on the skin condition (g2024007)
Scientific Title:Acronym
A study to evaluate the effects of food on the skin condition (g2024007)
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effects of food containing plant-derived ingredients on the skin condition and allergy-related symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Skin image analysis of redness
Key secondary outcomes
-Transepidermal water loss
-Skin capacitance and conductance
-Skin image analysis
-Blood analysis
-Stratum corneum analysis
-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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake of active food once a day for 4 weeks.
Interventions/Control_2
Intake of placebo food once a day for 4 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. Japanese males and females aged 20 to 59 years old at the time of informed consent.
2. Those who have subjective symptoms of red, itchy and dry skin.
3. Those who have subjective allergy-related symptoms.
4. Those who with at least one allergen-specific IgE antibody level of 0.35 UA/mL or higher.
Key exclusion criteria
1. Those who currently attend a clinic for treatment of skin diseases and allergic diseases.
2. Those who are/were undergoing allergen immunotherapy (sublingual immunotherapy) to cedar pollen allergen and/or mites allergen, at present or over the past 2 years.
3. Those who is presence of metabolic disease, abnormalities of gastrointestinal, circulatory or hematological, viral infection.
4. Those who have been infected with viruses of hepatitis B or C, syphilis or HIV.
5. Those who have had allergic attack (anaphylactic shock or other breathing difficulties) due to an allergic disease in the past.
6. Those who have a history of inpatient treatment for allergic diseases in the past previous hospitalization.
7. Those who have experienced allergic symptoms due to the intake of certain foods.
8. Those who use drugs on a regular basis.
9. Those who regularly take certain supplements or have plan to take them during the trial period.
10. Those who have excessive sunburn or scraped skin on the test sites, or have a beard.
11. Those who have experienced cosmetic operation or are going to go to beauty salon during the test period.
12. Those whose BMI is less than 18.5 kg/m2, or over 30 kg/m2.
13. Heavy drinkers.
14. Smokers
15. Those who are currently pregnant or breastfeeding, or wish to become pregnant during the trial period.
16. Those who plan to have a long business trip or travel.
17. Shift workers.
18. Outdoor workers.
19. Those who plan to participate in the other clinical trial during the trial period.
20. Those who are judged appropriate by the study director or person in charge.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Satoko |
| Middle name | |
| Last name | Fukagawa |
Organization
Kao Corporation
Division name
Human Health Care Products Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-7268
fukagawa.satoko@kao.com
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Yasu |
Organization
Kao Corporation
Division name
Human Health Care Products Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-7268
Homepage URL
yasu.tomoko@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
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
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-9064
morisaki.naoko@kao.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
| 2025 | Year | 04 | Month | 25 | 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 | 04 | Month | 11 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 11 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 07 | 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 | 04 | Month | 18 | Day |
Last modified on
| 2025 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065856
