UMIN-CTR Clinical Trial

Public title

Effects of the Test Product for Skin

Acronym

Effects of the Test Product for Skin

Scientific Title

Effects of the Test Product for Skin

Scientific Title:Acronym

Effects of the Test Product for Skin

Region

Japan

Condition

N/A(healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study examines effects of the product on skin condition.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

[1]Transepidermal water loss, skin moisture content, skin viscoelasticity (Week 0, Week 8)

Key secondary outcomes

*Secondary outcomes
[1]Observation for skin condition by a specialist (Week 0, Week 8)
[2]Questionnaire of physical feeling (Week 0, Week 4, Week 8)

*Other indexes
[1]Diagnosis by doctors (Week 0, Week 8)
[2]Subject's diary(From the first day of ingestion of a test material to the last day of the test)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Oral intake of the test product (4 capsules in a day; 8 weeks)

Interventions/Control_2

Oral intake of the placebo product (4 capsules in a day; 8 weeks)

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

30

years-old

<=

Age-upper limit

60

years-old

>

Gender

Female

Key inclusion criteria

[1]Females aged 30-59 years.
[2]Individuals who are healthy and have no chronic physical disease including skin disease.
[3]Individuals who are concerning on dry skin.
[4]Individuals whose written informed consent has been obtained.
[5]Individuals who can have an examination in a designated day.
[6]Individuals judged appropriate for the study by the principal.

Key exclusion criteria

[1]Individuals using medical products.
[2]Individuals who developed asthma in the past 3 months.
[3]Individuals who used or applied a drug for treatment of disease in the past 1 month.
[4]Individuals with strange skin conditions at measurement points.
[5]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease.
[6]Individuals who contract or have a history of serious gastrointestinal disease.
[7]Individuals with serious anemia.
[8]Individuals who are sensitive to test product or other foods, and medical products.
[9]Individuals who are or are possibly pregnant, or are lactating.
[10]Individuals who have an addiction to alcohol or a mental illness.
[11]Individuals who are a smoker.
[12]Individuals whose bowel habit is irregular.
[13]Individuals with possible changes of life style, such as working a night shift or conducting a long-term travel, during the test period.
[14]Individuals with probable seasonal allergy, such as pollinosis, during the test period.
[15]Individuals who cannot avoid daylight exposure during the test period.
[16]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 3 months or will ingest those foods during the test period.
[17]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months.
[18]Individuals who use cosmetics having a strong moisturizing effect or improvingg effect for wrinkle.
[19]Individuals who had been conducted an operation on the test spot in the past 6months.
[20]Individuals who participated in other clinical studies in the past 3 months.
[21]Individuals who and whose family work in a company developing or manufacturing functional foods.
[22]Individuals judged inappropriate for the study by the principal.

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Shuji Nakata

Organization

Medical Corporation Bokushinkai CLINTEXE Clinic

Division name

Director

Zip code

Address

4F Atago Green Hills Mori Tower 2-5-1 Atago Minato-ku Tokyo 105-6204, JAPAN

TEL

03-6801-8480

Email

info@tes-h.co.jp

Name of contact person

1st name
Middle name
Last name	Ryoma Shimizu

Organization

TES Holdings Co., Ltd

Division name

Administrative Department of Clinical Trials

Zip code

Address

6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN

TEL

03-6801-8480

Homepage URL

Email

r.shimizu@tes-h.co.jp

Institute

TES Holdings Co., Ltd

Institute

Department

Personal name

Organization

API CO., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

03

Month

17

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

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

2017

Year

02

Month

28

Day

Date of IRB

Anticipated trial start date

2017

Year

03

Month

19

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

03

Month

16

Day

Last modified on

2017

Year

09

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030471