UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028844 |
|---|---|
| Receipt number | 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 | 2020/02/28 17:54:42 |
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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
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
kfujii@interface-akita.com
Sponsor or person
Institute
Interface, Inc.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033011
