UMIN-CTR Clinical Trial

Public title

Skin moisturizing effect of oral intake of soy isoflavone.

Acronym

Skin moisturizing effect of oral intake of soy isoflavone.

Scientific Title

Skin moisturizing effect of oral intake of soy isoflavone.

Scientific Title:Acronym

Skin moisturizing effect of oral intake of soy isoflavone.

Region

Japan

Condition

water content of stratum corneum

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate skin moisuturizing effect by oral intake of isoflavone drink.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

water content of stratum corneum

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

soy isoflavones blended drink

Interventions/Control_2

Placebo drink

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

40

years-old

>

Gender

Female

Key inclusion criteria

1)Age between 20 and 39 at the time of informed consent
2)Female
3)Persons who had a normal nenstrual cycle(25days - 38days)
4)Persons who provided written voluntary consent to participate in the study

Key exclusion criteria

1)Persons who always took supplements that may affect the test results (isoflavone, equol, etc.)
2)Persons who took medicines that may affect the test results (estrogen, etc.)
3)Persons with a risk of allergy to test drink(soy)
4)Persons who had severe anemia
5)Persons who were under the care of a doctor for treatment of a disease or its prevention (hormone treatment, medicinal treatment, exercise treatment, diet treatment, etc.) or needed such treatments
6)Persons who had or previously had severe disease of the liver, kidney, heart, circulatory system, respiratory system, endocrine system, nervous system, sugar metabolism, lipid metabolism, alcoholism, chemical poisoning, etc. including those who were positive for hepatitis virus
7)Persons who attended dermatology clinics
8)Persons who had factors on the skin of the evaluation sites, which may affect the test results (diseases such as atopic dermatitis, urticaria, etc., inflammation, eczema, injury, acne, pimples, warts, blemishes, etc, or scars thereof)
9)Persons who have had special skincare procedures (beauty salon, esthetics salon, etc.) on the evaluation sites performed within the past 4 weeks or who plan to undergo such procedures during the test
10)Persons who had ultraviolet exposure that exceeds a normal lifestyle quota, such as working, exercising, swimming, or undertaking leisure activities for long hours outdoors, or intend to undertake such activities during the test
11)Persons who work nightshift or alternating day and night shifts
12)Persons who have participated in other clinical trials within the past 4 weeks or who intend to participate in other clinical trials during the scheduled period of this test (all clinical trials using cosmetics, foodstuffs, drugs, quasi-drugs, medical devices, etc.)
13)Persons deemed by the principal investigator (or study supervisor) to be inappropriate for participation in the test

Target sample size

24

Name of lead principal investigator

1st name
Middle name
Last name	Taizo Seki

Organization

Noevir Co., Ltd.

Division name

Groupwide Research and Development

Zip code

Address

112-1, Okadacho, Higashiohmi-shi, Shiga, Japan

TEL

0748-35-5452

Email

taizou_seki@n1.noevir.co.jp

Name of contact person

1st name
Middle name
Last name	Taizo Seki

Organization

Noevir Co., Ltd.

Division name

Groupwide Research and Development

Zip code

Address

112-1, Okadacho, Higashiohmi-shi, Shiga

TEL

0748-35-5452

Homepage URL

Email

taizo_seki@n1.noevir.co.jp

Institute

Noevir Co., Ltd.

Institute

Department

Personal name

Organization

Noevir 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

09

Month

03

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

2014

Year

08

Month

27

Day

Date of IRB

Anticipated trial start date

2014

Year

09

Month

04

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

09

Month

02

Day

Last modified on

2014

Year

10

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017476