UMIN-CTR Clinical Trial

Public title

A study on the effects of a dietary supplement intake on skin in adult female who feel dry skin

Acronym

A study on the effects of a dietary supplement intake on skin in adult female who feel dry skin

Scientific Title

A study on the effects of a dietary supplement intake on skin in adult female who feel dry skin

Scientific Title:Acronym

A study on the effects of a dietary supplement intake on skin in adult female who feel dry skin

Region

Japan

Condition

Dry skin

Classification by specialty

Dermatology

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

A study on the effects of supplement containing collagen intake on skin

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Moisture content of the stratum corneum, transepidermal water loss

Key secondary outcomes

Skin questionnaire

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

Prevention

Type of intervention

Food

Interventions/Control_1

Ingestion of placebo powder for 8 consecutive weeks

Interventions/Control_2

Ingestion of powder containing collagen 5,000mg per a day for 8 consecutive 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

59

years-old

>=

Gender

Female

Key inclusion criteria

1. Healthy females between the ages of 30 and 59
2. Subjects who feel dry skin in the screening test
3. Lower level of transepidermal water loss

Key exclusion criteria

1. Having dietary supplements, medicines, skin care preparation which include collagen, ceramide, hyaluronan-rich, or have had dietary supplements wchich have high effect on skin more than 3 times a week within the last one month prior to the screening test
2. Treated cosmetic care which affects mesuring site
3. Treated cosmetic care except for measuring sites, or hormonal therapy within the last one month prior to the screening test
4. Got a facial, a wash-rag, lost hair on measuring sites, or plan these actions within the last one month prior to the screening test
6. Planning to get a tan between the last one month prior to the screening test and the completion of the test within the last one month prior to the screening test
6. Washing the body using nylon a towel which provides strong skin irritation except for a soft towel
7. Having the wound or inflammatory disease affecting the measuring skin
8. Developing atopy or asthma, or have the its possibility
9. Feeling to trouble by rough skin around a menstruates
10. Employing on a pre-dawn shift or on night duty more than 2 times in the current stugy term
11. Being in development of diabetes, liver disease, kidney disease, or diseases affecting a secretion of sex hormones, or have its previous history
12. Having the medicines constantly
13. Developed hay fever between December and March in the past 3 years, or being expected to be developed the allergy symptoms on skin
14. Participated in other clinical study or are planned to participate in other clinical study after informed consent for the current study
15. Judged as unsuitable for the study based on the results of clinical and physical examination
16. Planning to become pregnant or lactate
17. Planning to go overseas
18. Took a blood sample or donated blood beyond the limit within the last one year prior to the screening test
19. Judged as unsuitable for the study based on the results of lifestyle questionnaire
20. Judged as unsuitable for the study by physician

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	KONDO Sumio

Organization

Medical Corporation Kenshokai, Fukushima Healthcare Center

Division name

Internal medicine

Zip code

Address

2-12-16, Tamagawa, Fukushima-ku, Osaka

TEL

06-6441-6848

Email

ko283434@ares.eonet.ne.jp

Name of contact person

1st name
Middle name
Last name	NAKAGAWA Takashi

Organization

Total Technological Consultant Co., Ltd.(TTC)

Division name

Clinical Research Planning Dept.

Zip code

Address

1-20-2 Ebisu Nishi, Shibuya-ku, Tokyo, Seibu Shinyokinko Ebisu Bldg

TEL

03-5459-5329

Homepage URL

Email

t.nakagawa@ttc-tokyo.co.jp

Institute

Total Technological Consultant Co., Ltd.(TTC)

Institute

Department

Personal name

Organization

Shinnihonseiyaku 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

2014

Year

06

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

2013

Year

11

Month

23

Day

Date of IRB

Anticipated trial start date

2013

Year

12

Month

03

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

06

Month

20

Day

Last modified on

2014

Year

12

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016677