UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038443 |
|---|---|
| Receipt number | R000043669 |
| Scientific Title | Examination of the wrinkle improvement effect in the consecutive use of the antiwrinkle product(MAW-1). |
| Date of disclosure of the study information | 2019/11/06 |
| Last modified on | 2020/03/04 10:58:07 |
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Basic information
Public title
Examination of the wrinkle improvement effect in the consecutive use of the antiwrinkle product(MAW-1).
Acronym
Effective examination of the antiwrinkle product (MAW-1).
Scientific Title
Examination of the wrinkle improvement effect in the consecutive use of the antiwrinkle product(MAW-1).
Scientific Title:Acronym
Effective examination of the antiwrinkle product (MAW-1).
Region
| Japan |
Condition
Condition
wrincle
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Use quasi drug(MAW-1) consecutively, and confirm a wrinkle improvement effect.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The wrincle depth evaluated by replica of eye area.
Wrinkle grade judgment by the Dermatologist.
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
Apply quasi drug(MAW-1) 2 times a day for 12 weeks to the outer corner of a half face allocated randomly by assignment director.
Interventions/Control_2
Apply placebo cosmetic 2 times a day for 12 weeks to the outer corner of a half face allocated randomly by assignment director.
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
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)It is an Asian 60 years or younger 40 years old or older
2)The person that wrinkle grade (with less than it of 5.0 more than grade 3.0) of the outer corner of the eye is observed
3)It is the nonuser of anticosmetics for wrinkle and the unregulated drug in most recent three months
4)Care after the everyday face-wash is around 1-3 articles of relatively simple care such as a lotion, emulsion, liquid cosmetics or person who do not carry it out
5)The person who can acquire an agreement by a document based on the free will by the person before an examination start
Key exclusion criteria
1)Person with chronic skin symptoms such as atopic dermatitis, contact-related dermatitis, skin hypersensitivity
2)Person with the abnormality that is remarkable in the skin state of the face which is a test part
3)The person who receives hormone replacement therapy
4)Person with the experience of beauty medical care affecting the test part
5)The person who I receive special facial care (facial beauty treatment salon P ring laser), and does not pass more than one month
6)The person who takes in the supplement which declared diet or a fair skin effect routinely
7)The extreme person that I tan or work and sports are not avoided outdoors for a long time
8)The person who used pharmaceutical products, an unregulated drug, a supplement, the health food which might have an influence on the final examination regularly
9)Person with a history of the past when I am dangerously ill to heart, liver, a digestive organ
10)An excessive cigarette and an alcohol habitual offender and the person that the eating habits are extremely irregular
11)During the pregnancy or the person who plans the pregnancy all over the person, the study time nursing it
12)In addition, the person who judged that a study person in charge or the study person in charge was ill-qualified
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Taeko |
| Middle name | |
| Last name | Chinen |
Organization
Medical corporation association Shizuyakai oozoranaika/hifuka
Division name
Dermatology
Zip code
170-0001
Address
4-6-2, Nishisugamo, Toshima Ku, Tokyo To
TEL
03-3910-1136
oozora@relife-inc.com
Public contact
Name of contact person
| 1st name | Hiromu |
| Middle name | |
| Last name | Katsuta |
Organization
ReLife,inc
Division name
Clinical Trial Division
Zip code
170-0013
Address
1-47-1, Higashiikebukuro , Toshima Ku, Tokyo To
TEL
03-5928-2501
Homepage URL
hkatsuta@relife-inc.com
Sponsor or person
Institute
Medical corporation association Shizuyakai oozoranaika/hifuka
Institute
Department
Personal name
Funding Source
Organization
Mandom 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
Medicos-group,inc
Address
1-47-1, Higashiikebukuro , Toshima Ku, Tokyo To
Tel
03-5928-3744
abecl-rinri@medicos-group.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | Month | 06 | 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
| 2019 | Year | 10 | Month | 09 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 02 | 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 | 30 | Day |
Last modified on
| 2020 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043669
