UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050422 |
|---|---|
| Receipt number | R000057418 |
| Scientific Title | The verification study for long-term intake safety and the effect on skin barrier function (moisturizing power) of test food intake; A randomized, placebo-controlled, double-blind, parallel study |
| Date of disclosure of the study information | 2023/02/24 |
| Last modified on | 2023/10/27 10:21:45 |
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Basic information
Public title
The verification study for long-term intake safety and the effect on skin barrier function (moisturizing power) of test food intake; A randomized, placebo-controlled, double-blind, parallel study
Acronym
The verification study for long-term intake safety and the effect on skin barrier function (moisturizing power) of test food intake
Scientific Title
The verification study for long-term intake safety and the effect on skin barrier function (moisturizing power) of test food intake; A randomized, placebo-controlled, double-blind, parallel study
Scientific Title:Acronym
The verification study for long-term intake safety and the effect on skin barrier function (moisturizing power) of test food intake
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to verify the long-term intake safety and the effect on skin barrier function (moisturizing power) of test food intake.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(Effectiveness evaluation)
1. Transepidermal Water Loss (TEWL)
* Assess these tests at screening (before consumption) and at 4, 8 and 12 weeks after consumption.
Key secondary outcomes
(Safety evaluation)
1.Physical measurement
2.Vital signs(Blood pressure/pulse)
3.Blood biochemistry
4.Blood hematology
5.Urinalysis
6.Adverse events
* Assess these tests at screening (before consumption) and at 4, 8 and 12 weeks after consumption and 4 weeks after consumption completed.
(Effectiveness evaluation)
1.Moisture of the skin surface
2.Visual Analogue Scale (VAS) of itching sensation
3.The Japanese version of Skindex-29
* Assess these tests at screening (before consumption) and at 4, 8 and 12 weeks after consumption.
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
12-weeks intake of the test food
Administration: Take 1 capsule after dinner with water or warm water
*If you forget to take the capsule, take them as soon as you remember within the day.
Interventions/Control_2
12-weeks intake of the placebo food
Administration: Take 1 capsule after dinner with water or warm water
*If you forget to take the capsule, take them as soon as you remember within the day.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Healthy male and female subjects who feel dryness skin and whose ages are 20 <= years old <65
Key exclusion criteria
1. Subjects who have serious current or past diseases such as brain disease, malignant tumor, immune disease, diabetes, renal disease, heart disease, thyroid disease, adrenal disease, and other metabolic diseases
2. Currently undergoing treatment for any of the following chronic diseases: arrhythmia, dyslipidemia, hypertension, and other chronic diseases
3. Subjects with severe skin disease symptoms such as atopy or dermatitis
4. Subjects who cannot intentionally refrain from exposure to direct sunlight, such as sunburn
5. Subjects who are allergic to medications and/or the test food related products
6. Subjects who are pregnant, breast-feeding, or planning to become pregnant
7. Currently, or within the past 2 weeks, subjects who have a habit of continuously taking drugs (pharmaceuticals and quasi-drugs with moisturizing effects, anti-wrinkle effects, etc.) or health foods that claim to have skin-improving effects, or subjects who have a habit of applying the above drugs on their arms
8. Subjects who are judged to be unsuitable as subjects based on clinical test values and skin test values at the time of screening
9. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Yamashita |
Organization
Pharma Foods International Co., Ltd.
Division name
Research and Development
Zip code
615-8245
Address
1-49, Goryo-Ohara, nishikyo-ku, Kyoto city, Kyoto, Japan
TEL
075-748-9829
y-yamashita@pharmafoods.co.jp
Public contact
Name of contact person
| 1st name | Angga |
| Middle name | |
| Last name | Sanjaya |
Organization
Pharma Foods International Co., Ltd.
Division name
Research and Development
Zip code
615-8245
Address
1-49, Goryo-Ohara, nishikyo-ku, Kyoto city, Kyoto, Japan
TEL
075-748-9829
Homepage URL
angga-sanjaya@pharmafoods.co.jp
Sponsor or person
Institute
Pharma Foods International Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
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
Ethics Committees of Yoga Allergy Clinic
Address
4-32-16 Yoga,Setagaya-ku,Tokyo 158-0097 Japan
Tel
03-5491-4478
jim@medipharma.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
RD11010TF04
Org. issuing International ID_1
Ethics Committees of Yoga Allergy Clinic
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
株式会社ファーマフーズ（京都府）/Pharma Foods International Co., Ltd.(Kyoto)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | 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
30
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 | 02 | Month | 03 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 28 | Day |
Date of closure to data entry
| 2023 | Year | 07 | Month | 28 | Day |
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 10 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 24 | Day |
Last modified on
| 2023 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057418
