UMIN-CTR Clinical Trial

Public title

A study for the skin moisturizing effect of a dietary supplement intake on in adult female who are aware of skin dryness and elasticity

Acronym

A study for the skin moisturizing effect of a dietary supplement intake

Scientific Title

A study for the skin moisturizing effect of a dietary supplement intake on in adult female who are aware of skin dryness and elasticity

Scientific Title:Acronym

A study for the skin moisturizing effect of a dietary supplement intake

Region

Japan

Condition

Healthy volunteers

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

A study for the skin moisturizing effect of a dietary supplement intake for 12 weeks

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Stratum corneum water content (4, 8, and 12 weeks after a dietary supplement intake)

Key secondary outcomes

Transepidermal water loss, skin elasticity, collagen score, and questionnaires (4, 8, and 12 weeks after a dietary supplement intake)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of test food (high dose) for 12 consecutive weeks

Interventions/Control_2

Intake of test food (low dose) for 12 consecutive weeks

Interventions/Control_3

Intake of placebo for 12 consecutive weeks

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

45

years-old

<=

Age-upper limit

64

years-old

>=

Gender

Female

Key inclusion criteria

1. Females between the ages of 45 and 64
2. Subjects who are aware of skin dryness, elasticity and lower level of Stratum corneum water content

Key exclusion criteria

1. Subjects who usually take some drugs, functional foods, or cosmetics including active ingredients
2. Subjects who usually take some drugs, functional foods, etc. which would affect skin condition
3. Subjects who got some cosmetic surgery, or hormone therapy which would affect the target skins
4. Subjects who plan to have ultraviolet exposure within a month before the screening test
5. Subjects who wash the body providing strong skin irritation
6. Subjects who usually use bath additives
7. Subjects who have the wounds or inflammatory diseases which would affect the target skins
8. Subjects who have the wounds or inflammatory diseases which would affect the target skins
9. Subjects who might have allergic symptoms (pollinosis, etc.) and use medicines in this study
10. Subjects who feel skin roughness on the target skins around a menstruates
11. Subjects who employ on a pre-dawn shift or on night duty more than 2 times in this study
12. Subjects who are plan to go overseas
13. Subjects who have asthma or would have asthma during this study
14. Subjects who have severe diseases or diseases which affect a secretion of sex hormones
15. Subjects who are at risk of having allergic reaction related to this study
16. Subjects who have diseases which affect this study
17. Subjects who judged as unsuitable based on the results of clinical and physical examination
18. Subjects who participated other clinical trial within 3 months prior to this study or plan to participate other clinical trial after acquiring consent to this study
19. Pregnant or lactating women
20. Subjects who are judged as unsuitable for this study by the principal investigator

Target sample size

45

Name of lead principal investigator

1st name
Middle name
Last name	Sumio Kondo

Organization

Medical Corporation Kensho-kai, Fukushima Healthcare Center

Division name

Internal Medicine,Department of Neurosurgery

Zip code

Address

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

TEL

06-6441-6848

Email

ko293434@ares.eonet.ne.jp

Name of contact person

1st name
Middle name
Last name	Takashi Nakagawa

Organization

TTC Co., Ltd

Division name

Clinical Research Planning Department

Zip code

Address

1-20-2 Ebisunishi, shibuya-ku, Tokyo

TEL

03-5459-5329

Homepage URL

Email

t.nakagawa@ttc-tokyo.co.jp

Institute

TTC Co., Ltd.

Institute

Department

Personal name

Organization

not open to the public

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

01

Month

22

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

01

Month

12

Day

Date of IRB

Anticipated trial start date

2017

Year

01

Month

23

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

01

Month

21

Day

Last modified on

2017

Year

07

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029658