UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035286 |
|---|---|
| Receipt number | R000040163 |
| Scientific Title | Clinical trial on the efficacy on the wrinkle conforming to the guideline of Japanese Cosmetic Science Society |
| Date of disclosure of the study information | 2018/12/19 |
| Last modified on | 2019/06/18 09:15:36 |
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Basic information
Public title
Clinical trial on the efficacy on the wrinkle conforming to the guideline of Japanese Cosmetic Science Society
Acronym
Clinical trial on the efficacy on the wrinkle conforming to the guideline of Japanese Cosmetic Science Society
Scientific Title
Clinical trial on the efficacy on the wrinkle conforming to the guideline of Japanese Cosmetic Science Society
Scientific Title:Acronym
Clinical trial on the efficacy on the wrinkle conforming to the guideline of Japanese Cosmetic Science Society
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the usefulness of wrinkles of the outer corner of the eyes by long-term continuous use of active ingredient formulated cream.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual evaluation of wrinkle grade
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
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Apply the test cosmetic product to the designated left or right half face.
Interventions/Control_2
Apply the placebo cosmetic product to the designated left or right half face.
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
| 30 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Healthy women aged 30 to 59 years old at the time of acquisition.
2) Individuals who are healthy and are currently not treating with any disease.
3) Individuals who have wrinkles of grade 3 to 5 in the outer corner of the eyes.
4) Individuals who obtained the written consent to participate in the study after explanation of the details of the study and understanding it sufficiently
Key exclusion criteria
1) Individuals who have a history of allergy to cosmetics.
2) Individuals undergoing hormone replacement therapy.
3) Individuals who are pregnant or lactating.
4) Individuals who have experienced cosmetic care that will affect the test site.
5) Individuals who acknowledge that doctors involved in the examination are not appropriate.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Daiki |
| Middle name | |
| Last name | Kyoutani |
Organization
Nikoderm Research Inc.
Division name
Evaluation Division
Zip code
541-0052
Address
1-6-14, Azuchimachi, Chuoku, Osaka, Japan
TEL
06-6125-3501
kyoutani@nikoderm.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Yamashita |
Organization
Nikoderm Research Inc.
Division name
Evaluation Division
Zip code
541-0052
Address
1-6-14, Azuchimachi, Chuoku, Osaka, Japan
TEL
06-6125-3501
Homepage URL
yamashita@nikoderm.com
Sponsor or person
Institute
Nikoderm Research Inc.
Institute
Department
Personal name
Funding Source
Organization
COSMOS TECHNICAL CENTER CO., LTD.
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
Society for Glycative Stress Research
Address
2-13-10, Shinjyuku, Shinjyukuku, Tokyo, Japan
Tel
03-6709-8842
info@toukastress.jp
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 19 | 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
76
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
Terminated
Date of protocol fixation
| 2018 | Year | 10 | Month | 29 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 17 | Day |
Last modified on
| 2019 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040163
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
