UMIN-CTR Clinical Trial

Public title

A Study for the Effect of Food Containing Ceramide on Skin Quality

Acronym

A Study for the Effect of Food Containing Ceramide on Skin Quality

Scientific Title

A Study for the Effect of Food Containing Ceramide on Skin Quality

Scientific Title:Acronym

A Study for the Effect of Food Containing Ceramide on Skin Quality

Region

Japan

Condition

Effect of Food Containing Ceramide on Skin Quality

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to evaluate efficacy of food containing ceramide on skin quality by Japanese adult males and fmmales (aged 20-60 years).

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Color-difference
Transepidermal water loss
Skin moisture content
Skin texture

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

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

Other

Interventions/Control_1

Oral ingestion of the test product (12 weeks)

Interventions/Control_2

Oral ingestion of the control product (12 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

20

years-old

<=

Age-upper limit

60

years-old

>

Gender

Male and Female

Key inclusion criteria

[1]Japanese males and females aged 20-60 years
[2]Individuals who are healthy and do not treat any disease
[3]Individuals who are aware of skin dullness or dryness
[4]Individuals who sign the consent document after explanation of this study

Key exclusion criteria

[1]Individuals using medical products
[2]Individuals with skin disease, such as atopic dermatitis, or strange skin conditions disease at measurement points
[3]Individuals who are sensitive to test products
[4]Individuals with probable seasonal allergy, such as pollinosis, during the test period
[5]Individuals who used cosmetics corresponding to quasi-drug or having whitning or moisturizing effect in the past 1 month or will ingest those foods during the test period
[6]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplyments claiming whitning effect in the past 1 month or will ingest those foods during the test period
[7]Individuals who will get sunburned during the test period
[8]Individuals who conducted actions, such as hormone replacement therapy, beauty treatment or cosmetic medicine, or diseasae treatment requiring hospital admission, to affect measurement points in the past 3 months
[9]Individuals who are alcohol dependent or have other mental disabilities
[10]Individuals with possible changes of life style, such as working a night shift or conducting a long-term travel, during the test period
[11]Individuals who participated in other clinical studies in the past three months
[12]Individuals who are or are posslibly, or are lactating
[13]Individuals judged inappropriate for the study by the principal

Target sample size

70

Name of lead principal investigator

1st name
Middle name
Last name	Shuji Nakata

Organization

Medical Corporation Bokushinkai CLINTEXE Clinic

Division name

Internal Department

Zip code

Address

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

TEL

03-5405-1059

Email

info@tes-h.co.jp

Name of contact person

1st name
Middle name
Last name	Toshiyasu Tamura

Organization

TES Holdings Co., Ltd

Division name

Department of Clinical Trial

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

info@tes-h.co.jp

Institute

TES Holdings Co., Ltd.

Institute

Department

Personal name

Organization

Maruzen Pharmaceuticals 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

2015

Year

02

Month

20

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

2015

Year

02

Month

09

Day

Date of IRB

Anticipated trial start date

2015

Year

02

Month

21

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

02

Month

10

Day

Last modified on

2016

Year

05

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019160