UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041295 |
|---|---|
| Receipt number | R000047159 |
| Scientific Title | A verification study of the effects of consumption of ORYZA CERAMIDE on the skin barrier function using TEWL as an index: A randomized, double-blind, placebo-controlled, parallel-group trial |
| Date of disclosure of the study information | 2020/08/03 |
| Last modified on | 2021/03/19 13:36:46 |
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Basic information
Public title
A verification study of the effects of consumption of ORYZA CERAMIDE on the skin barrier function using TEWL as an index
Acronym
A verification study of the effects of consumption of ORYZA CERAMIDE on the skin barrier function using TEWL as an index
Scientific Title
A verification study of the effects of consumption of ORYZA CERAMIDE on the skin barrier function using TEWL as an index: A randomized, double-blind, placebo-controlled, parallel-group trial
Scientific Title:Acronym
A verification study of the effects of consumption of ORYZA CERAMIDE on the skin barrier function using TEWL as an index
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of consumption of the test food for 12 weeks on the skin barrier function in healthy Japanese subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The measured values of transepidermal water loss (TEWL) of the cheek at 12 weeks after the start of test-food consumption
Key secondary outcomes
1. The measured values of TEWL of the cheek at 4and 8weeks after the start of test-food consumption
2. The amount of changes of the measured values of TEWL of the cheek between screening and at 4, 8, and 12 weeks after the start of test-food consumption
3. The measured values of the listed items at 4, 8, and 12 weeks after the start of test-food consumption
4. The amount of changes of the measured values of the listed items between screening and at 4, 8, and 12 weeks after the start of test-food consumption
<the evaluation items of No. 3 and 4>
moisture of the skin (cheek and lips), TEWL (scalp, upper arm, back, lips, back of the right hand), viscoelasticity of the cheek, total number of noticeable facial pores, numbers of noticeable facial pores, facial pores with prominent opening, facial pores with prominent darkening, and facial skin pigmentations (small size and large size: Lv 1), areas of facial skin pigmentations (small size and large size: Lv 1), numbers of wrinkles under the eyes (total of the both eyes, average of the both eyes, right, left), total length of crow's feet, total area of crow's feet, facial skin brightness, facial skin texture, skin oiliness, facial pores, the index of melanin and facial pigmentations, facial wrinkles, the index of porphyrin and sebum prediction, and facial corneum
5. The measured values of the questionnaire at 4, 8, and 12 weeks after the start of test-food 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
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: 12 weeks
Test food: Capsule containing ORYZA CERAMIDE(R)-PCD
Administration: Take one capsule per day at any time during the day.
*If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_2
Duration: 12 weeks
Test food: Placebo
Administration: Take one capsule per day at any time during the day.
*If you forget to take the test food, take it 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
| Not applicable |
Gender
Female
Key inclusion criteria
1. Healthy Japanese adult women
2. Subjects who are anxious about skin moisture
3. Subjects who are judged as eligible to participate in the study by the physician
4. Subjects whose TEWL of cheek is relatively high at screening
Key exclusion criteria
1. Subjects undergoing medical treatment or having a medical history of malignant tumor, heart failure, or myocardial infarction
2. Subjects carrying a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Subjects undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage as part of their daily intake
5. Subjects regularly taking medications (including herbal medicines) and supplements
6. Subjects allergic to medications and/or the test-food-related products
7. Subjects who are pregnant, lactating, or intending to become pregnant
8. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial
9. Subjects who have got cosmetic surgery
10. Subjects who habitually receive skincare treatment (e.g., aesthetic treatment) or use instruments for beauty treatment (e.g., facial treatment device)
11. Subjects who use any other products except for general skin care products (a cream/essence, a skin pack, skin lotion, milky lotion, sunscreen, and these all-in-one products)
12. Subjects who have been diagnosed with atopic dermatitis
13. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | YAMAMOTO |
Organization
ORTHOMEDICO Inc.
Division name
CEO
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
kazu@orthomedico.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | SUZUKI |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
Oryza Oil & Fat Chemical Co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel
03-5793-3623
IRB@takara-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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 03 | 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
44
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
| 2020 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 04 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 03 | Day |
Last modified on
| 2021 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047159
