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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028844
Receipt No. R000033011
Scientific Title Efficacy test on wrinkles of skin external preparation (C-002)
Date of disclosure of the study information 2017/08/28
Last modified on 2018/09/07

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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 No longer recruiting
Date of protocol fixation
2017 Year 08 Month 22 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 28 Day
Last follow-up date
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
2018 Year 09 Month 07 Day


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

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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