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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032658
Receipt No. 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 2019/04/04

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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
Email 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
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

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
Email 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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 31
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 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
2019 Year 04 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037221

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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