UMIN-CTR Clinical Trial

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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	application of cosmetics including active ingredient.
Interventions/Control_2	application of cosmetics without active ingredient.
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 are using cosmetics or quasi-drugs that are effective against wrinkles . 5) Individuals who have experienced cosmetic care that will affect the test site. 6) 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 Yuki Middle name Last name Yamashita
Organization	Nikoderm Research Inc.
Division name	Evaluation Division
Zip code	5410052
Address	1-6-14, Azuchimachi, Chuoku, Osaka, Japan
TEL	06-6125-3501
Email	yyamashita@nikkolgroup.com

Public contact
Name of contact person	1st name Yuka Middle name Last name Anno
Organization	Nikoderm Research Inc.
Division name	Evaluation Division
Zip code	5410052
Address	1-6-14, Azuchimachi, Chuoku, Osaka, Japan
TEL	06-6125-3501
Homepage URL
Email	yanno@nikkolgroup.com

Sponsor
Institute	Nikoderm Research Inc.
Institute
Department

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 Resarch
Address	2-13-10,Shinjyuku,Shinjyuku-ku,Tokyo
Tel	03-6709-8842
Email	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	2019 Year 11 Month 05 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	80
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	2019 Year 10 Month 15 Day
Date of IRB	2019 Year 10 Month 30 Day
Anticipated trial start date	2019 Year 11 Month 06 Day
Last follow-up date	2020 Year 01 Month 23 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 28 Day
Last modified on	2020 Year 02 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043769