UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000034784 |
|---|---|
| Receipt number | R000039663 |
| Scientific Title | Clinical evaluation of wrinkle improvement by NWNC, S study No. 1 |
| Date of disclosure of the study information | 2018/11/08 |
| Last modified on | 2020/11/09 13:30:17 |
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Basic information
Public title
Clinical evaluation of wrinkle improvement by NWNC, S study No. 1
Acronym
Clinical evaluation of wrinkle improvement by NWNC, S study No. 1
Scientific Title
Clinical evaluation of wrinkle improvement by NWNC, S study No. 1
Scientific Title:Acronym
Clinical evaluation of wrinkle improvement by NWNC, S study No. 1
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 confirm that NWNC can diminish the appearance of wrinkles caused by dryness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Wrinkle depth of outer corner of an eye evaluated by replica of eye area.
Key secondary outcomes
Wrinkle grade of outer corner of the eye by a picture of eye area
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Application of test cosmetic on corner of an eye for 4 weeks.
No application of test cosmetic on the another corner of the eye for 4 weeks
Interventions/Control_2
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
| Not applicable |
Gender
Female
Key inclusion criteria
(1)A person who has 1 to 3 wrinkle grade in eye area.
(2)A Japanese woman who is 30 years old or older when consented.
(3)A person who consented to participate in this study with a written consent.
Key exclusion criteria
(1)A person who varies in wrinkle grade on the left and right
(2)A person who has factors influencing the test at the evaluation site (those with atopic dermatitis and the like, trauma, burns, inflammation, acne, warts or traces thereof)
(3)A person who has history of beauty care that influence the test at the evaluation site, or those who plans to receive it during the study period
(4)A person who received special treatment (facial esthetics etc) at the evaluation site within the past 3 months, or who will receive it during the study period
(5)Pregnant or lactating
(6)A person who has experienced severe adverse reaction (allergy, etc.) to cosmetics
(7)A person who continues to use cosmetics, health foods, etc. that indicate or appeal the similar efficacy of the test cosmetics to the evaluation site
(8)A person judged as ineligible by investigator with other reasons
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Takano |
Organization
Medical Corporation Hokubukai Utsukushigaoka Hospital
Division name
Center for Clinical Pharmacology
Zip code
Address
61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan
TEL
011-882-0111
takano@ughp-cpc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryota Wakimoto |
Organization
Medical Corporation Hokubukai Utsukushigaoka Hospital
Division name
Center for Clinical Pharmacology
Zip code
Address
61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan
TEL
011-882-0111
Homepage URL
wakimoto@ughp-cpc.jp
Sponsor or person
Institute
Medical Corporation Hokubukai Utsukushigaoka Hospital
Institute
Department
Personal name
Funding Source
Organization
Noevir , Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
医療法人北武会 美しが丘病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 08 | 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
| 2018 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 06 | Day |
Last modified on
| 2020 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039663
| Research Plan | |
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| Registered date | File name |
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