UMIN-CTR Clinical Trial

Basic information
Public title	Clinical evaluation of wrinkle improvement by NWEC, S study No. 2
Acronym	Clinical evaluation of wrinkle improvement by NWEC, S study No. 2
Scientific Title	Clinical evaluation of wrinkle improvement by NWEC, S study No. 2
Scientific Title:Acronym	Clinical evaluation of wrinkle improvement by NWEC, S study No. 2
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
Email	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
Email	wakimoto@ughp-cpc.jp

Sponsor
Institute	Medical Corporation Hokubukai Utsukushigaoka Hospital
Institute
Department

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
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	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 09 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 21 Day
Last follow-up date	2018 Year 12 Month 19 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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039668