UMIN-CTR Clinical Trial

Public title

A Study on the skin effect by carbonate cosmetics

Acronym

A Study on the skin effect by carbonate cosmetics

Scientific Title

A Study on the skin effect by carbonate cosmetics

Scientific Title:Acronym

A Study on the skin effect by carbonate cosmetics

Region

Japan

Condition

Healthy adults

Classification by specialty

Dermatology

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To confirm the dermatological efficacy of carbon dioxide for healthy female skin of the face

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Evaluation of the stratum corneum water content, the transepidermal water loss, the skin color, the skin viscoelasticity, the stratum corneum cell size, blood flow measurement, and the dermatological assessment after the repeated treatment for 2, 4 and 8 weeks with the carbonate cosmetics

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -but assessor(s) 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

Apply the carbonate cosmetics for facial skin for twice a day for 8 weeks

Interventions/Control_2

Apply placebo cosmetics for facial skin for twice a day for 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

35

years-old

<=

Age-upper limit

45

years-old

>=

Gender

Female

Key inclusion criteria

1. Healthy females aged from 35 to 45 years old.
2. Person whose skin with chapping or person with dry skin.
3. Person with wrinkle problem
4. Person with dullness skin.
5. Person whom skin state changes with body condition change (example: Stress, fatigue and lack of sleep) easily.
6. People who can agree to participate in a test spontaneously in document.
7. Person who can agree with blood pressure taking by fingers.
8. Person who can stop use of the essence during a test period

Key exclusion criteria

1. Person who have abnormalities in the skin of a measured region
2. Person who are out patients.
3. Person with the anamnesis of an alcohol or drug dependence.
4. Person who have possibilities for emerging allergy to cosmetics and foods.
5. Persons who are pregnant or lactating, or planned to become pregnant during a test period.
6. Person who participate in the other clinical studies within 4 weeks in the past, or person who have a schedule which participates in other clinical studies during a test period.
7. Person who are judges as unsuitable for the study by the investigator for other reason.
8. Those to whom the person himself/herself and a family are working for the cosmetics company, the food company, an advertising agency, investigation and consultant business, and a mass media-related company.
9. Patients with vascular function disorder, or person who have severe poor circulation.
10. Person who was abnormal by blood pressure or electrocardiogram inspection.
11. Current smoker.

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Yoshinori Sugiyama

Organization

Kao Corporation

Division name

R&D Health Beauty Products Research

Zip code

Address

2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, Japan

TEL

03-5630-9534

Email

sugiyama.yoshinori@kao.co.jp

Name of contact person

1st name
Middle name
Last name	Mika Shuin

Organization

Kao Corporation

Division name

R&D Health Beauty Products Research

Zip code

Address

2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, Japan

TEL

03-5630-9534

Homepage URL

Email

shuuin.mika@kao.co.jp

Institute

701 Research Inc.

Institute

Department

Personal name

Organization

Kao Corporation

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

株式会社セブンオーワンリサーチ/Above Access（東京都）

Date of disclosure of the study information

2016

Year

01

Month

07

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

2015

Year

12

Month

16

Day

Date of IRB

Anticipated trial start date

2016

Year

01

Month

07

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

01

Month

07

Day

Last modified on

2016

Year

04

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023662