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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025658
Receipt No. R000029516
Scientific Title A study for improving effects on the blood flow and the skin by carbonate cosmetics
Date of disclosure of the study information 2017/01/23
Last modified on 2017/07/18

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Basic information
Public title A study for improving effects on the blood flow and the skin by carbonate cosmetics
Acronym A study for improving effects on the blood flow and the skin by carbonate cosmetics
Scientific Title A study for improving effects on the blood flow and the skin by carbonate cosmetics
Scientific Title:Acronym 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
1st name
Middle name
Last name Yoshinori Sugiyama
Organization Kao Corporation
Division name R&D Skin Care Products Research
Zip code
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
1st name
Middle name
Last name Yasuko Amano
Organization Kao Corporation
Division name R&D Skin Care Products Research
Zip code
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)

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 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

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
2017 Year 01 Month 10 Day
Date of IRB
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

Other
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

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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