UMIN-CTR Clinical Trial

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

Healthy Japanese subjects

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

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

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"

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name

Organization

NAGASE BeautyCare Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Hiroo Dermatology Clinic & Mentors inc.

Medical Corporation Seishinkai, Takara Clinic

Nerima Medical Association, Minami-machi Clinic

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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)

Date of disclosure of the study information

2020

Year

10

Month

23

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2020

Year

10

Month

23

Day

Last modified on

2021

Year

07

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048195