UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037467 |
|---|---|
| Receipt number | R000042714 |
| Scientific Title | A Study on the skin change by continuous use of carbonated cosmetics |
| Date of disclosure of the study information | 2019/09/10 |
| Last modified on | 2019/07/24 14:14:46 |
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Basic information
Public title
A Study on the skin change by continuous use of carbonated cosmetics
Acronym
A Study on the skin change by continuous use of carbonated cosmetics
Scientific Title
A Study on the skin change by continuous use of carbonated cosmetics
Scientific Title:Acronym
A Study on the skin change by continuous use of carbonated 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 efficacy and safety of of the test products for healthy male and female facial skin
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the dermatological assessment by doctor after 2 and 4 weeks of continuous use of test products
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved 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
Use the test product every twice a day for 4 weeks
Interventions/Control_2
Use the placebo every twice a day for 4 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
| 20 | years-old | <= |
Age-upper limit
| 39 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy male and females
Key exclusion criteria
-Subjects with atopic dermatitis and pollen allergy
-Pregnancies and lactations
-Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Hosokawa |
Organization
Kao Corporation
Division name
Skin Care Research
Zip code
131-8501
Address
2-1-3 Bunka,Sumida-ku Tokyo 131-8501, JAPAN
TEL
+81-3-5630-7286
hosokawa.masaru@kao.com
Public contact
Name of contact person
| 1st name | Aiko |
| Middle name | |
| Last name | Kiyozuka |
Organization
Kao Corporation
Division name
Skin Care Research
Zip code
131-8501
Address
2-1-3 Bunka,Sumida-ku Tokyo 131-8501, JAPAN
TEL
+81-3-5630-7287
Homepage URL
kiyozuka.aiko@kao.com
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
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-9220
uesaka.toshio@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
DRC株式会社（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 10 | 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 | 08 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 23 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 07 | 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 | 07 | Month | 24 | Day |
Last modified on
| 2019 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042714
