UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy test on wrinkles of skin external preparation (C-002)
Acronym	Efficacy test on wrinkles of skin external preparation (C-002)
Scientific Title	Efficacy test on wrinkles of skin external preparation (C-002)
Scientific Title:Acronym	Efficacy test on wrinkles of skin external preparation (C-002)
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Dermatology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to clear whether the skin external preparation can reduce eye area wrinkles.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The wrinkle grade evaluation and the image analysis with replica on crow's-feet wrinkle area and depth during the study period for 8 weeks
Key secondary outcomes	The wrinkle improvement recognition by subjects during the study period for 8 weeks

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 the test material and the placebo on one half of the corner of the eye and lower eyelid and the other side, respectively, twice a day for 8 weeks.
Interventions/Control_2	Apply the test material and the placebo on one half of the corner of the eye and lower eyelid and the other side, respectively, twice a day for 8 weeks.
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	35 years-old <=
Age-upper limit	64 years-old >=
Gender	Female
Key inclusion criteria	(1)A person who has 3 to 5 wrinkle grade in eye area. (2)A Japanese female aged from 35 to 64 years(when a written informed consent was obtained)(3)A person who consented to participate in this study in the document
Key exclusion criteria	(1) Person who has a history of allergy (2) Those receiving hormone replacement therapy (3) During pregnancy, breast-feeding (4) Persons who have experienced cosmetic care that will affect the site to be examined (5) Person who is receiving facial beauty treatment (6) Others who acknowledge that doctors involved in the examination are not appropriate
Target sample size	55

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazumi Nozawa
Organization	Interface, Inc.
Division name	Not applicable
Zip code
Address	2-8-1-7, Nakadori, Akita-shi, Akita, 010-0001, Japan
TEL	018-827-7155
Email	kazumi.nozawa@interface-akita.com

Public contact
Name of contact person	1st name Middle name Last name Keiko Fujii
Organization	Interface, Inc.
Division name	Not applicable
Zip code
Address	2-8-1-7, Nakadori, Akita-shi, Akita, 010-0001, Japan
TEL	018-827-7155
Homepage URL
Email	kfujii@interface-akita.com

Sponsor
Institute	Interface, Inc.
Institute
Department

Funding Source
Organization	Kao 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
Address
Tel
Email

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	2017 Year 08 Month 28 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	2017 Year 08 Month 22 Day
Date of IRB	2017 Year 08 Month 22 Day
Anticipated trial start date	2017 Year 08 Month 28 Day
Last follow-up date	2017 Year 12 Month 02 Day
Date of closure to data entry
Date trial data considered complete	2018 Year 01 Month 18 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 08 Month 26 Day
Last modified on	2020 Year 02 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033011