UMIN-CTR Clinical Trial

Public title

Effects of consumption of the test food on skin condition in healthy Japanese subjects

Acronym

Effects of consumption of the test food on skin condition in healthy Japanese subjects

Scientific Title

Effects of consumption of the test food on skin condition in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study

Scientific Title:Acronym

Effects of consumption of the test food on skin condition in healthy Japanese subjects

Region

Japan

Condition

Healthy Japanese subjects

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To verify the effects of consumption of the test food for six weeks on skin viscoelasticity, skin collagen concentration, skin moisture in healthy Japanese subjects

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

1. The measured value of viscoelasticity of the skin (cheek) at six weeks after consumption (6w)

Key secondary outcomes

1. The measured value of viscoelasticity of the skin (back of the hands) at 6w

2. The measured value of viscoelasticity of the skin (cheek and back of the hands) at four weeks after consumption (4w)

3. The amount of change from screening (before consumption; Scr) of viscoelasticity of the skin (cheek and back of the hands) to 4w and 6w

4. The measured value and the amount of change from Scr of transepidermal water loss (cheek), water content (cheek), and dermal measurement (cheek and back of the hands) at 4w and 6w

5. The measured value and the amount of change from Scr of visual analog scale (VAS) score (skin moisture, skin roughness, skin texture, sagging of the skin, skin elasticity, skin viscoelasticity, and makeup condition), 1,5-anhydroglucitol (1,5-AG), and glycoalbumin at 6w

Study type

Interventional

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

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Duration: Six weeks
Test food: Capsule containing pentadecyl-containing auran oil
Administration: Take one capsule with water without chewing once a day

*If you forget to take the test food, take it as soon as you remember within the day.

Interventions/Control_2

Duration: Six weeks
Test food: Placebo capsule
Administration: Take one capsule with water without chewing once a day

*If you forget to take the test food, 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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Japanese

2. Men or women

3. Subjects aged 20 or more

4. Healthy subjects

5. Subjects who are concerned about skin viscoelasticity

6. Subjects who are judged as eligible to participate in the study by the physician

7. Subjects whose low echogenic band (LEB) (back of the hands) are not 0

8. Subjects whose viscoelasticity of the skin (cheek) are relatively low

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. Subjects 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 use or take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily

5. Subjects who currently taking medications (including herbal medicines) and supplements (particularly including docosahexaenoic acid and/or eicosapentaenoic acid)

6. Subjects who are allergic to medicines and/or the test food related products

7. Subjects who have been diagnosed with atopic dermatitis

8. Subjects who use any products except for cosmetic creams, beauty essence, all-in-one cosmetic makeup, skin lotions such as face masks, milky lotions, and sunscreen for daily skincare

9. Subjects who habitually receive skincare treatment (e.g., aesthetic treatment) or use instruments for beauty treatment (e.g., facial treatment device)

10. Subjects who have undergone cosmetic surgery

11. Subjects who are aspirin-intolerance or currently taking medications including aspirin

12. Subjects who are pregnant, lactation, or planning to become pregnant

13. Subjects who suffer from COVID-19

14. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial

15. Subjects who are judged as ineligible to participate in the study by the physician

Target sample size

52

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

Sea Act Co., LTD

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Medical Corporation Seishinkai, Takara Clinic

Hiroo Dermatology Clinic & Mentors inc.

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

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)

広尾皮フ科クリニック (東京都)
Hiroo Dermatology Clinic & Mentors inc. (Tokyo, Japan)

南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)

Date of disclosure of the study information

2022

Year

01

Month

24

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

56

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

2022

Year

01

Month

19

Day

Date of IRB

2022

Year

01

Month

19

Day

Anticipated trial start date

2022

Year

01

Month

25

Day

Last follow-up date

2022

Year

06

Month

06

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2022

Year

01

Month

24

Day

Last modified on

2022

Year

11

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053282