UMIN-CTR Clinical Trial

Basic information
Public title	Verification for the effects of consumption of the test food on anti-aging effects. (skin lifting, increased viscoelasticity, anti-glycation etc.)
Acronym	Verification for the effects of consumption of the test food on anti-aging effects. (skin lifting, increased viscoelasticity, anti-glycation etc.)
Scientific Title	Verification for the effects of consumption of the test food on anti-aging effects. (skin lifting, increased viscoelasticity, anti-glycation etc.): An open-label trial
Scientific Title:Acronym	Verification for the effects of consumption of the test food on anti-aging effects. (skin lifting, increased viscoelasticity, anti-glycation etc.)
Region	Japan

Condition
Condition	Healthy Japanese subjects
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Along with the product renewal of the test food, we will examine the anti-aging effects (skin lifting, increased viscoelasticity, anti-glycation, etc.) of consumption of the test food for the purpose of using it in promotional materials for consumers.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1. The difference of the long axis of an ellipse of the stamps between lying down and standing positions on the cheek 2. The ratio of the long axis of an ellipse of the stamps of lying down and standing positions on the cheek
Key secondary outcomes	1. The ratio of the resistance to mechanical force versus the ability of recovery (R2), the ratio of the elastic part of the suction phase versus the immediate recovery during the relaxation phase (R5), and the ratio of the immediate recovery versus the amplitude after suction (R7) 2. Total number of noticeable facial pores, number of noticeable facial pores, number of facial pores with prominent openings, number of facial pores with prominent darkening, number of facial skin pigmentations (small size), areas of facial skin pigmentations (small size), number of facial skin pigmentations (large size), areas of facial skin pigmentations (large size), number of wrinkles under the eyes (sum of the both eyes), number of wrinkles under the eyes (average of the both eyes), number of wrinkles under the eyes (right), number of wrinkles under the eyes (left), total length of crow's feet, total area of crow's feet, facial skin tone, facial skin brightness, moisture value, oiliness and texture 3. Plasma levels of pentosidine and carboxymethyl lysine (CML) 4. Subjective symptoms of "My skin is saggy," "My skin is not resilient and elastic," "Makeup does not sit well," "My skin has wrinkles and fine wrinkles," "My skin is not moisturized," "My skin is rough," "My skin is not clear," "My skin is dark and dull," "My skin looks pale," and "I tend to be constipated"

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 food: Beauty powder containing soybean extract fermented product and proteoglycan Administration: Take two packs per day with water and no chewing. *If you forget to take the tablets, take tablets as soon as you remember during 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	40 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	1. Healthy Japanese women who are 40 years old and over. 2. Subjects who are anxious about sagging skin 3. Subjects who are judged as eligible to participate in the study by the physician 4. Subjects who have relatively large ratio and rate of the long axis of an ellipse of the stamps between lying down position and standing position
Key exclusion criteria	1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who have been diagnosed with atopic dermatitis 5. Subjects who have got cosmetic surgery 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 have been overexposed to the sun within the last month, are going to be overexposed to the sun without protection, or can not prevent sunburn during this trial (from the agreement to participate in this trial to the final test) 8. Subjects who habitually receive skincare treatment (e.g., aesthetic treatment) or use instruments for beauty treatment (e.g., facial treatment device) 9. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 10. Currently taking medicines (include herbal medicines) and supplements 11. Subjects who are allergic to medications and/or products that contain the study ingredients. Particularly, soybeans, crab, shrimp, gelatin, and salmon allergy. 12. Subjects who are pregnant, breast-feeding, and planning 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 or plan to participate another trial during this trial. 14. Subjects who are judged as ineligible to participate in the study by the physician.
Target sample size	14

Research contact person
Name of lead principal investigator	1st name Tatsuya Middle name Last name Izumi
Organization	Hiroo Dermatology Clinic & Mentors inc.
Division name	Director
Zip code	150-0012
Address	1&2F Hiroo Masugi Annex Bldg., 5-25-5, Hiroo, Shibuya-ku, Tokyo, Japan
TEL	03-5795-1112
Email	dr_izumi@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	NAGASE BeautyCare Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Hiroo Dermatology Clinic & Mentors inc. 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
Email	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	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) 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 10 Month 23 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	15
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 10 Month 16 Day
Date of IRB	2020 Year 10 Month 16 Day
Anticipated trial start date	2020 Year 10 Month 24 Day
Last follow-up date	2021 Year 04 Month 10 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 10 Month 23 Day
Last modified on	2021 Year 07 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048195