UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046466 |
|---|---|
| Receipt number | R000052948 |
| Scientific Title | A study to evaluate the effects of food containing plant-derived ingredients on the skin condition |
| Date of disclosure of the study information | 2021/12/24 |
| Last modified on | 2025/01/28 13:52:50 |
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Basic information
Public title
A study to evaluate the effects of food containing plant-derived ingredients on the skin condition
Acronym
A study to evaluate the effects of food on the skin condition
Scientific Title
A study to evaluate the effects of food containing plant-derived ingredients on the skin condition
Scientific Title:Acronym
A study to evaluate the effects of food on the skin condition
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Clinical immunology | Dermatology | 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 blood biomarkers
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Transepidermal water loss
Stratum corneum hydration
Skin image analysis
Allergy-related blood biomarkers
Key secondary outcomes
Japanese version of Skindex-16
Japanese Allergic Rhinitis Standard Quality of Life Questionnaire
Other endpoints for exploratory analysis
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 8 weeks.
Interventions/Control_2
Intake of placebo food once a day 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
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Males and females aged 20 to 59 years old at the time of informed consent.
2)Those who have subjective symptoms of dry, red and itchy skin.
3)Those who have any of the followings.
a. past diagnosis of allergic diseases.
b. subjective allergy-related symptoms.
c. family members with allergy diseases.
4)Those whose BMI is in the normal range (18.5 to 30.0).
5)Those who are judged appropriate by the study director or person in charge.
Key exclusion criteria
1) Those who currently attend a clinic for treatment of skin diseases.
2) Those who currently attend a clinic for treatment of allergic diseases.
3) Those who attend a clinic for treatment of seasonal rhinitis every year.
4) Those who have experienced allergic symptoms due to the intake of certain foods.
5) Those who attend or attended a clinic within a month before the trial for treatment of the diseases which are considered to influence the outcome.
6) Those who have been infected with viruses of hepatitis B or C, syphilis or HIV.
7) Those who use drugs which are considered to influence the outcome within two weeks before the trial.
8) Those who regularly take certain supplements or have plan to take them during the trial period.
9) Those who have excessive sunburn on the test sites.
10) Those who have experienced cosmetic operation on the test sites.
11) Those who are strongly resistant to blood collection or have experienced sickness due to it.
12) Those who plan to participate in the other clinical trial during the trial period.
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 have the fever or respiratory symptoms in themselves or their family living together, or have close contact with the persons infected with COVID-19 within two weeks before the trial.
17) Those who are judged not appropriate by the study director or person in charge.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Katsuyoshi |
| Middle name | |
| Last name | Saito |
Organization
Kao Corporation
Division name
Health & Wellness Products Research
Zip code
131-8501
Address
2-1-3 Bunka Sumida-ku Tokyo
TEL
+81-3-5630-7520
Saitou.katsuyoshi@kao.com
Public contact
Name of contact person
| 1st name | Satoko |
| Middle name | |
| Last name | Fukagawa |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
113-8421
Address
Juntendo Univ. A-12F KAO-GAUDI 2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL
+81-70-3297-0978
Homepage URL
fukagawa.satoko@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
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
Human Research Ethics committee,Kao Corporation
Address
2-1-3 Bunka Sumida-ku Tokyo
Tel
+81-3-5630-7263
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
| 2021 | Year | 12 | Month | 24 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 11 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 12 | Month | 24 | Day |
Last modified on
| 2025 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052948
