UMIN-CTR Clinical Trial

Public title

A study for the skin moisturizing effect of a beverage intake on in adult female who are aware of skin dryness (Preliminary test)

Acronym

A study for the skin moisturizing effect of a beverage intake

Scientific Title

A study for the skin moisturizing effect of a beverage intake on in adult female who are aware of skin dryness (Preliminary test)

Scientific Title:Acronym

A study for the skin moisturizing effect of a beverage intake

Region

Japan

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the safety and skin moisturizing effect of intake of test food for 8 weeks

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Stratum corneum water content

Key secondary outcomes

Transepidermal water loss
VISIA

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of 2 test foods per day for 8 consecutive weeks

Interventions/Control_2

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

64

years-old

>=

Gender

Female

Key inclusion criteria

1.Healthy females from 20 to 64 years of age
2.Subjects who are aware of skin dryness and lower level of Stratum corneum water content

Key exclusion criteria

Subjects
1.who usually drink hard water or mineral water
2.who usually take some foods, drugs, functional foods, etc. which would affect skin condition
3.who got some cosmetic surgery which would affect the target skins
4.who got some cosmetic surgery, or hormone therapy which would affect the Other than target skins within 1 year before the screening test
5.who got esthetic treatments would affect the target skins within 1 month before the screening test, or plan the act
6.who plan to have ultraviolet exposure within 1 month before the screening test
7.who wash the body using a nylon towel, etc. which provides strong skin irritation
8.who usually use bath additives
9.who have the wounds or inflammatory diseases which would affect the target skins
10.who might have symptom of pollinosis during between February to April in the past 3 years or who are expected to have allergic symptoms on the skin during this study
11.who feel skin roughness on the target skin around a menstruates
12.who employ on a pre-dawn shift or on night duty more than 2 times in this study
13.who are planning to go overseas
14.who have asthma or would have asthma during this study
15.who have or has medical history serious disease
16.who have allergic reaction related to this study or who cannot ingest carbonated beverages
17.who have disease under treatment or who have serious disease medical history requiring medication treatment affecting this study
18.who are judged inappropriate for the study according to the results of screening test
19.who have participated in other clinical studies within 1 month, or are planning to participate in other clinical studies during this study
20.who are pregnant or lactating, or plan to become pregnant or lactate during this study
21.who are judged as unsuitable due to lifestyle questionnaire
22.who are judged as unsuitable for the study by investigator for other reasons

Target sample size

10

Name of lead principal investigator

1st name
Middle name
Last name	Yasumasa Sugiura

Organization

Georgia Premium Foods

Division name

-

Zip code

Address

3-6-9, Shiba Minato-ku, Tokyo

TEL

03-6275-1023

Email

sugiura@nabeghlavi.co.jp

Name of contact person

1st name
Middle name
Last name	Kyohei Hashimoto

Organization

TTC Co., Ltd.

Division name

Clinical Research Planning Department

Zip code

Address

Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo

TEL

03-5459-5329

Homepage URL

Email

k.hashimoto@ttc-tokyo.co.jp

Institute

TTC Co., Ltd.

Institute

Department

Personal name

Organization

Georgia Premium Foods

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

2019

Year

02

Month

07

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

10

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

2019

Year

01

Month

25

Day

Date of IRB

2019

Year

01

Month

25

Day

Anticipated trial start date

2019

Year

02

Month

08

Day

Last follow-up date

2019

Year

05

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2019

Year

02

Month

07

Day

Last modified on

2019

Year

06

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040775