UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Study on the skin effect by carbonate cosmetics
Title of the study (Brief title)	A Study on the skin effect by carbonate cosmetics
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Dermatology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
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

Research contact person
Name of lead principal investigator	Yoshinori Sugiyama
Organization	Kao Corporation
Division name	R&D Health Beauty Products Research
Address	2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, Japan
TEL	03-5630-9534
Email	sugiyama.yoshinori@kao.co.jp

Public contact
Name of contact person	Mika Shuin
Organization	Kao Corporation
Division name	R&D Health Beauty Products Research
Address	2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, Japan
TEL	03-5630-9534
Homepage URL
Email	shuuin.mika@kao.co.jp

Sponsor
Institute	701 Research Inc.
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Kao Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	株式会社セブンオーワンリサーチ/Above Access（東京都）

Other administrative information
Date of disclosure of the study information	2016 Year 01 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 01 Month 07 Day
Last modified on	2016 Year 04 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023662