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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038443
Receipt No. 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 2019/10/17

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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
Email 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
Email hkatsuta@relife-inc.com

Sponsor
Institute Medical corporation association Shizuyakai oozoranaika/hifuka
Institute
Department

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
Email 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 Preinitiation
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 31 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
2019 Year 10 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043669

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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