UMIN-CTR Clinical Trial

Public title

Effects of consumption of the test food in skin viscoelasticity of healthy Japanese subjects

Acronym

Effects of consumption of the test food in skin viscoelasticity of healthy Japanese subjects

Scientific Title

Effects of consumption of the test food in skin viscoelasticity of healthy Japanese subjects: A randomized, double-blind, placebo-controlled, parallel-group comparison trial

Scientific Title:Acronym

Effects of consumption of the test food in skin viscoelasticity of 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 on viscoelasticity of the skin.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

The measured value of viscoelasticity of the skin (cheek) (R7) at eight weeks after consumption.

Key secondary outcomes

1. The measured value of viscoelasticity of the skin (cheek) (R7) at four weeks after consumption.

2. The measured values and change values from screening and advance examination of the following items at four and eight weeks after consumption:
viscoelasticity of the skin (cheek) (R1, R2, R3, R4, R5, R6, R8 and R9), viscoelasticity of the skin (upper arm), moisture of the skin (cheek and upper arm), transepidermal water loss (cheek and upper arm), intensity of cheek, skin thickness of cheek, low echologenic band (LEB) of cheek, score of advanced glycation end products (AGEs) of middle finger, "skin moisture", "skin roughness", "skin texture", "sagging of the skin", "skin elasticity", "viscoelasticity of the skin", "makeup condition", "skin redness", "wrinkles", pentosidine, carboxy methyl lysine (CML) and 3-deoxyglucosone (3-DG)

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: Eight weeks
Test food: Plant extract
Administration: Take two capsules, once a day after breakfast.

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

Interventions/Control_2

Duration: Eight weeks
Test food: Placebo
Administration: Take two capsules, once a day after breakfast.

*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

Female

Key inclusion criteria

1. Healthy Japanese adult women

2. Subjects who are anxious about viscoelasticity of the facial skin

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

4. Subjects who have relatively low viscoelasticity of the skin (cheek) before screening and advance examination

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

5. Currently taking medicines (include herbal medicines) and supplements

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

7. Subjects who are pregnant, breast-feeding, and planning to become pregnant

8. 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

9. Subjects who have got cosmetic surgery

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

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

12. Subjects who have been diagnosed with atopic dermatitis

13. Subjects who may change their lifestyles (e.g., working late-night shift, taking a long trip) during the study

14. Subjects who cannot refrained from exposure to direct sunlight such as sunburn intentionally during the study

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

Target sample size

40

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

planning-department@orthomedico.jp

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name

Organization

Oryza Oil & Fat Chemical 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.

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

09

Month

24

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

44

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

09

Month

15

Day

Date of IRB

2020

Year

09

Month

15

Day

Anticipated trial start date

2020

Year

09

Month

24

Day

Last follow-up date

2021

Year

01

Month

16

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2020

Year

09

Month

24

Day

Last modified on

2021

Year

04

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047802