UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025658 |
|---|---|
| Receipt number | 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 13:23:56 |
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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
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
amano.yasuko@kao.co.jp
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029516
