UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038383 |
|---|---|
| Receipt number | R000043741 |
| Scientific Title | A study on skin improving effects of skin care products for Chinese having consciousness of sensitive skin |
| Date of disclosure of the study information | 2020/02/01 |
| Last modified on | 2019/10/25 10:21:21 |
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Basic information
Public title
Evaluation of skin care products for Chinese having consciousness of sensitive skin
Acronym
Evaluation of skin care products for Chinese having consciousness of sensitive skin
Scientific Title
A study on skin improving effects of skin care products for Chinese having consciousness of sensitive skin
Scientific Title:Acronym
Evaluation of skin care products for Chinese having consciousness of sensitive skin
Region
| Asia(except Japan) |
Condition
Condition
Healthy adults
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To survey for Chinese having consciousness of sensitive skin and confirm the efficacy of skin care products on the skin of them
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the transepidermal water loss, after using with skin care products for a week and four weeks
Key secondary outcomes
- Evaluation of the stratum corneum water content, sebum secretion, skin color, skin texture, dermatological assessment, stinging test, inflammatory cytokines, a questionnaire survey and VAS "Visual Analog Scale" of skin conditions
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Applying designated meke up remover, face wash, water besed lotion, lotion and face cream on facial skin twice a day for four weeks instead of skin care products that they usually use.
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 39 | years-old | >= |
Gender
Female
Key inclusion criteria
1.Person who has been to Shanghai for more five years.
2.Healthy female aged from 20 to 49 years old.
3.Person who has sensitive consciousness.
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 regions.
2.Person who regularly goes to hospital.
3.Person with the anamnesis of an alcohol or a drug dependence.
4.Person who regularly use drugs (hypnotic drug, anti-allergic drug, analgetic drug, hormonal drug, laxative, antiflatulent etc...).
5.Person who has possibilities for emerging allergy to cosmetics (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, severe 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 members are working for the cosmetics company, the food company, an advertising agency, investigation and consultant business, and a mass media-related company.
12.Person who experienced medical cosmetic treatments (i.e. cosmetic surgery, collagen injection etc..)
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Kaizu |
Organization
Kao Corporation
Division name
R&D Skin Care Products Research
Zip code
250-0002
Address
5-3-28, Kotobukicho, Odawara, Kanagawa, 250-0002, Japan
TEL
0465-34-0559
kaizu.kazuhiro@kao.com
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Watanabe |
Organization
Kao Corporation
Division name
R&D Skin Care Products Research
Zip code
250-0002
Address
5-3-28, Kotobukicho, Odawara, Kanagawa, 250-0002, Japan
TEL
0465-34-0559
Homepage URL
watanabe.daisuke2@kao.com
Sponsor or person
Institute
Consumer Behaivor Research CORP
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
Shanghai Skin Disease Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-7263
morisaki.naoko@kao.com
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
上海市皮膚病医院(上海)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 25 | Day |
Last modified on
| 2019 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043741
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