UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study for improving effects on the blood flow and the skin by carbonate cosmetics
Title of the study (Brief title)	A study for improving effects on the blood flow and the skin by carbonate cosmetics
Region	Japan

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

Objectives
Narrative objectives1	To confirm the efficacy of carbon dioxide on the facial blood flow and the skin in healthy females
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of the stratum corneum water content, transepidermal water loss, sebum secretion, skin color, skin viscoelasticity, stratum corneum cell size and composition, blood flow measurement and dermatological assessment after repeated treatments for 4 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	No need to know

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Apply the carbonate cosmetics and the designated lotion on facial skin for twice a day for 4 weeks
Interventions/Control_2	Apply the placebo cosmetics and the designated lotion on facial skin for twice a day for 4 weeks
Interventions/Control_3	Apply the carbonate cosmetics and the designated lotion and emulsion on facial skin for twice a day for 4 weeks
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 female aged from 35 to 45 years old. 2. Person who is concerned about their skin being rough, dry, wrinkling and dull. 3. Person whose skin state changes with body condition (example: stress, fatigue and lack of sleep) easily. 4. Person who can agree to participate in the study voluntarily in writing. 5. Person who can agree to change her currently-using cosmetics to designated ones during the test period.
Key exclusion criteria	1. Person who has abnormalities in the skin of the measurement region 2. Person who regularly goes to hospital. 3. Person with the anamnesis of an alcohol or drug dependence. 4. Person who regularly use drug (hypnotic drug, anti-allergic drug, analgetic drug, hormonal drug, laxative, antiflatulent etc..). 5. Person who has possibilities for emerging allergy to cosmetics and/or foods (including experiences of skin irritation by cosmetics within a year). 6. Person who has allergy to adhesive tape and/or medical tape. 7. Person who suffers pollen allergy, rhinitis and atopic dermatitis. 8. Person who is pregnant or lactating, or planned to become pregnant during a test period. 9. Person who participates in the other clinical studies within 4 weeks in the past, or person who scheduled to participate in other clinical studies during the test period. 10. Person who is judged as unsuitable for the study by the investigator for other reasons. 11. Person who herself and/or her family member are working for the cosmetics company, the food company, an advertising agency, investigation and consultant business, and a mass media-related company. 12. Patient with vascular function disorder, or person who has excessive sensitivity to cold. 13. Person who has abnormal blood pressure or electrocardiogram testing result. 14. Current smoker. 15. Person who experienced medical cosmetic treatment (i.e. cosmetic surgery, collagen injection etc..)
Target sample size	40

Research contact person
Name of lead principal investigator	Yoshinori Sugiyama
Organization	Kao Corporation
Division name	R&D Skin Care Products Research
Address	5-3-28, Kotobukicho, Odawara, Kanagawa, 250-0002, Japan
TEL	0465-35-3175
Email	sugiyama.yoshinori@kao.co.jp

Public contact
Name of contact person	Yasuko Amano
Organization	Kao Corporation
Division name	R&D Skin Care Products Research
Address	5-3-28, Kotobukicho, Odawara, Kanagawa, 250-0002, Japan
TEL	0465-35-3175
Homepage URL
Email	amano.yasuko@kao.co.jp

Sponsor
Institute	Kao Corporation
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)

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	花王株式会社（神奈川県）

Other administrative information
Date of disclosure of the study information	2017 Year 01 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 10 Day
Anticipated trial start date	2017 Year 01 Month 30 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	2017 Year 01 Month 13 Day
Last modified on	2017 Year 07 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029516