UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034784
Receipt No. R000039663
Official scientific title of the study Clinical evaluation of wrinkle improvement by NWNC, S study No. 1
Date of disclosure of the study information 2018/11/08
Last modified on 2018/11/06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Official scientific title of the study Clinical evaluation of wrinkle improvement by NWNC, S study No. 1
Title of the study (Brief title) 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 Kazuhiko Takano
Organization Medical Corporation Hokubukai Utsukushigaoka Hospital
Division name Center for Clinical Pharmacology
Address 61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan
TEL 011-882-0111
Email takano@ughp-cpc.jp

Public contact
Name of contact person Ryota Wakimoto
Organization Medical Corporation Hokubukai Utsukushigaoka Hospital
Division name Center for Clinical Pharmacology
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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 10 Month 25 Day
Anticipated trial start date
2018 Year 11 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 11 Month 06 Day
Last modified on
2018 Year 11 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039663

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.