UMIN-CTR Clinical Trial

Public title

A study for the effect of the powdered food on skin dry

Acronym

A study for the effect of the powdered food on skin dry

Scientific Title

A study for the effect of the powdered food on skin dry

Scientific Title:Acronym

A study for the effect of the powdered food on skin dry

Region

Japan

Condition

Healthy female

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the effects of the powdered food containing collagen peptide, ceramide, amino acid and glucosamine on skin dry.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Moisture Content of the Stratum Corneum

Key secondary outcomes

Transepidermal water Loss
The skin evaluation by dermatologists
Improvement of symptoms

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

Institution is not considered as adjustment factor.

Blocking

Concealment

No need to know

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Ingestion of the powdered food containing collagen peptide, ceramide, amino acid, glucosamine 3g/day in 8 weeks

Interventions/Control_2

Ingestion of the placebo food 3g/day in 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

50

years-old

>

Gender

Female

Key inclusion criteria

1.Healthy female aged from 30 to 49 years old.
2.Persons who are aware of skin dryness.
3.Persons with water content in the stratum corneum =<50 and not severe dried skin.

Key exclusion criteria

1.Persons with a severe or progressive condition or symptom
2.Persons with a skin disease such as atopic dermatitis or eczema
3.Persons with food allergy
4.Persons with lactose intolerance
5.Persons who regularly used a drug , quasi drug, supplement or healthy food that affect this study.
6.Persons receiving special facial care
7.Persons who will get sunburned during the test period
8.Persons who are pregnant or who are planning or desiring pregnancy during the study period
9.Persons who are breastfeeding
10.In addition, persons who are judged inappropriate as the subject of this study by the investigator or sub-investigator

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Hiroshi Ochiai

Organization

Meiji Company Limited

Division name

Product Development Department

Zip code

Address

1-2-10 Shinsuna Koto-ku Tokyo

TEL

03-5653-0492

Email

hiroshi.ochiai@meiji.co.jp

Name of contact person

1st name
Middle name
Last name	Yuji Kawate

Organization

Meiji Company Limited

Division name

Product Development Department

Zip code

Address

1-2-10 Shinsuna Koto-ku Tokyo

TEL

03-5653-0492

Homepage URL

Email

yuuji.kawate@meiji.com

Institute

Meiji Company Limited

Institute

Department

Personal name

Organization

Meiji Company Limited

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

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

医療法人社団快晴会　しらゆり皮フ科・整形外科　新横浜スキンラボセンター（神奈川県）

Date of disclosure of the study information

2016

Year

09

Month

30

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

Results

1. Analysis of subjects including suspected of seasonal allergic rhinitis, stratum corneum water content in the active food group was significantly improved after 4 and 8 weeks-ingestion compared with before-ingestion, however there was no significant difference in the placebo food group. There was no significant difference between two groups.
2. Excluding subjects suspected of seasonal allergic rhinitis, the change of stratum corneum water content in 4 weeks-ingestion of active food group was significantly increased compared with placebo food group.
3. No adverse effects were observed in both groups.

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

11

Month

12

Day

Date of IRB

Anticipated trial start date

2015

Year

11

Month

14

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Jpn Pharmacol Ther 2017 45(7) 1167-78

Registered date

2015

Year

11

Month

15

Day

Last modified on

2017

Year

08

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022863