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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020491
Receipt No. R000023662
Scientific Title A Study on the skin effect by carbonate cosmetics
Date of disclosure of the study information 2016/01/07
Last modified on 2016/04/22

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Basic information
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
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

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

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
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

Public contact
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

Sponsor
Institute 701 Research Inc.
Institute
Department

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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