UMIN-CTR Clinical Trial

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