UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000032658 |
|---|---|
| Receipt number | R000037221 |
| Scientific Title | A verification study of safety and effects of the consumption of Beverage of Fermented Plant Extract SW containing low-molecular-weight collagen on making skin lighter and more beautiful in healthy Japanese women: an open-label trial |
| Date of disclosure of the study information | 2018/05/21 |
| Last modified on | 2021/05/24 10:02:12 |
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Basic information
Public title
A verification study of safety and effects of the consumption of Beverage of Fermented Plant Extract SW containing low-molecular-weight collagen on making skin lighter and more beautiful in healthy Japanese women: an open-label trial
Acronym
A verification study of making lighter and more beautiful skin
Scientific Title
A verification study of safety and effects of the consumption of Beverage of Fermented Plant Extract SW containing low-molecular-weight collagen on making skin lighter and more beautiful in healthy Japanese women: an open-label trial
Scientific Title:Acronym
A verification study of making lighter and more beautiful skin
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 that the test beverage effects of lighter and more beautiful skin
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Melanin concentrations on facial skin
* Quantify the facial melanin concentrations by Mexameter
* Perform the test at screening and examination before consumption and at 12 weeks after consumption
Key secondary outcomes
1. Erythema concentrations on facial skin
2. Doctor observations
tone of the skin
3. Skin assessment
4. Subjective symptoms (the Likert scale)
5. Blood test
high-sensitivity CRP level
*1 Quantify and evaluate the redness of erythema on the facial skin by Mexameter
*2 Each item was assessed with a five-point grading scale from 1 (marked improvement) to 5 (deterioration). The smaller number indicates better skin condition
*3 Quantify and evaluate facial pigmentations, wrinkles, skin texture, pores, skin tone, and redness by Robo Skin Analyzer
*4 Each item was assessed with a six-point grading scale from 1 (strongly agree) to 6 (strongly disagree). The smaller number indicates better skin condition
*1-5 Perform these tests at screening and examination before consumption and at 12 weeks after consumption
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: 12 weeks
Test beverage: Beverage of Fermented Plant Extract SW containing low-molecular-weight collagen
Administration: Drink a cup of the beverage with an attached dosing cup (20 mL) once a day before breakfast
* If you forget to drink the test beverage, drink it as soon as you remember within the day.
Interventions/Control_2
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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. Japanese women ages 30 years and up who are dissatisfied with their skin
2. Subjects who are judged as eligible to participate in the study by the physician.
3. Within the subjects who met the 2nd inclusion criteria, subjects whose facial melanin concentrations are relatively high as evaluated by Mexameter
Key exclusion criteria
1. At least one previous medical history or under the treatment of malignant tumor, heart failure, or myocardial infarction
2. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver failure, kidney failure, cerebrovascular disorder, rheumatism, diabetes, dyslipidemia, hypertension, or any other chronic diseases
3. Subjects who use or take "FOSHU", "Foods with Functional Claims", or other functional food/beverage daily
4. Subjects who have been diagnosed with atopic dermatitis
5. Subjects who are undergoing medical treatment for dryness or inflammation of their skin by a dermatologist, or are difficult to test because of a wound on the measurement part of the skin
6. 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)
7. Subjects who regularly receive skin care treatment (massages etc.) or use beauty products (facial equipment etc.)
8. Subjects who have changed their makeup habits within the last three months, or are going to change their makeup habits during this trial (from the agreement to participate in this trial to the final test)
9. Subjects who have been overexposed to the sun within the last month, or are going to be overexpose to the sun during this trial (from the agreement to participate in this trial to the final test)
10. Subjects who are currently taking medications (including herbal medicines) and supplements
11. Subjects who are allergic to soybeans, apple, banana, peach, kiwi fruit, Japanese yam, sesame seeds, gelatin, medicines, and/or the test beverage related products
12. Subjects who are pregnant, breast-feeding, or plan to become pregnant
13. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial
14. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size
29
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
Yagumo Kousan Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hiroo Dermatology Clinic & Mentors inc.
Faculty of Human Sciences, Waseda University
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
info@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
広尾皮フ科クリニック (東京都)
Hiroo Dermatology Clinic & Mentors inc. (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 21 | Day |
Related information
URL releasing protocol
Unpublished
Publication of results
Published
Result
URL related to results and publications
https://newfoodindustry.securesite.jp/entry/2005.html
Number of participants that the trial has enrolled
31
Results
Hondou K, Yamashita S, Suzuki N, Hara T, Izumi T. Consumption of liquid of fermented plant extract SW (LFPE-SW) results in skin lightening and related cosmetic improvements among healthy Japanese women: an open-label trial. New Food Industry. 2020; 62(5): 311-324
Results date posted
| 2021 | Year | 05 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 05 | Month | 01 | Day |
Baseline Characteristics
Refer to the paper
Participant flow
Refer to the paper
Adverse events
Refer to the paper
Outcome measures
Refer to the paper
Plan to share IPD
Undecided
IPD sharing Plan description
To require consultation among related companies
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 22 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 21 | 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 | 05 | Month | 21 | Day |
Last modified on
| 2021 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037221
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