UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035147 |
|---|---|
| Receipt number | R000040060 |
| Scientific Title | An investigation study for lifting up the skin improvement with ingestion of proteoglycan for 12 weeks on Japanese adult women |
| Date of disclosure of the study information | 2018/12/05 |
| Last modified on | 2022/05/31 10:29:56 |
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Basic information
Public title
An investigation study for lifting up the skin improvement with ingestion of proteoglycan for 12 weeks on Japanese adult women
Acronym
An investigation study for lifting up the skin improvement with ingestion of proteoglycan for 12 weeks on Japanese adult women
Scientific Title
An investigation study for lifting up the skin improvement with ingestion of proteoglycan for 12 weeks on Japanese adult women
Scientific Title:Acronym
An investigation study for lifting up the skin improvement with ingestion of proteoglycan for 12 weeks on Japanese adult women
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 improvement in skin lifting with the test food in Japanese adult women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The ratio of the long axis of an ellipse of the stamps of lying down position and standing position
* Put a stamp on the cheek at lying down position and standing position, and evaluate the long axis of an ellipse of the stamps of both positions
* Assess the measured value at screening (before consumption) and at 4, 8, and 12 weeks after consumption and calculate the amount of change.
Key secondary outcomes
1. The difference of the long axis of an ellipse of the stamps between lying down position and standing position
2. Moisture of the skin
3. Transepidermal Water Loss (TEWL)
4. Viscoelasticity of the skin
5. Facial pigmentations
6. Wrinkles on facial skin
7. Facial skin texture
8. Facial pores
9. Facial skin tone
10. Facial redness
11. Measure lift up the skin (3D)
12. Measure the dermis
13. Questionnaire (the Likert scale)
*1-13 Assess the measured value at screening (before consumption) and at 4, 8, and 12 weeks after consumption and calculate the amount of change.
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
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: 12 weeks
Test food: Capsule containing salmon nasal cartilage-derived proteoglycan
Administration: Take one capsule after dinner with water
* Daily dose should be taken within the day. If you forget to take the capsule, take it as soon as you remember within the day.
Interventions/Control_2
Duration: 12 weeks
Test food: Placebo capsule
Administration: Take one capsule after dinner with water
* Daily dose should be taken within the day. If you forget to take the capsule, 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 experiencing sagging the skin
3. Subjects who are judged as eligible to participate in the study by the dermatologist
4. Subjects whose ratio of the long axis of an ellipse of the stamps of lying down position and standing position are relatively large
Key exclusion criteria
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure or myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or other chronic diseases
4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily
5. Subjects who have been diagnosed with atopic dermatitis
6. Subjects who use any other products except for cosmetic creams, beauty essence, all-in-one cosmetic makeup, and face masks, skin lotions, milky lotions, and sunscreen, for daily skincare.
7. Subjects who habitually receive skincare treatment (e.g., aesthetic treatment) or use instruments for beauty treatment (e.g., facial treatment device)
8. Subjects who are currently taking medications (including herbal medicines) and dietary supplements, particularly allergic to salmon
9. Subjects who are allergy to medications and/or products that contain the study ingredients. Particularly, salmon allergy
10. Subjects who are pregnant, breast-feeding, or planning to become pregnant
11. Subjects who have been participated in another clinical study within the last three months prior to signing informed consent for the current study
12. Subjects who are ineligibility to participate in the study based on the evaluation of the principal dermatologist
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo YAMAMOTO |
Organization
ORTHOMEDICO Inc.
Division name
CEO
Zip code
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 | |
| Middle name | |
| Last name | Naoko SUZUKI |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
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
NIHON PHARMACEUTICAL CO.,LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hiroo Dermatology Clinic & Mentors inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
広尾皮フ科クリニック (東京都)
Hiroo Dermatology Clinic & Mentors inc. (Tokyo, Japan)
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)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | 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
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
| 2018 | Year | 11 | Month | 12 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 05 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 05 | Day |
Last modified on
| 2022 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040060
