UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation test of wrincle improvement effect by application of eggshell membrane cosmetics (Super Odi Grand Evolution) (pilot study)
Title of the study (Brief title)	Evaluation test of wrincle improvement effect by eggshell membrane cosmetics
Region	Japan

Condition
Condition	wrincle
Classification by specialty	Dermatology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objectives of this study is to reveal the wrincle improvement effect of eggshell membrane cosmetics (super odi grand evolution).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	The wrincle depth evaluated by replica of eye area
Key secondary outcomes	The wrincle grade evaluated by a picture of eye area

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 3 drops of Super Ode Grand Evolution containing hydrolyzed eggshell membrane 3 times a day for 2 weeks to the outer corner of a half face allocated randomly by assignment director.
Interventions/Control_2	Three drops of placebo cosmetic that removed the hydrolyzed eggshell membrane from Super Ode Grand Evolution on the outer corner of the half face randomly assigned by assignment director were applied three times a day for 2 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	30 years-old <=
Age-upper limit	60 years-old >
Gender	Female
Key inclusion criteria	(1) Age ranges from 30 to 60 (2) female (3) those who mainly have wrinkles of wrinkle grade 1 to 3 (4) Person who obtains consent of voluntary participation in examination by 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) A patch test was conducted on the test cosmetics and the replica agent, and a person with abnormality appeared on the skin (6) Person who is receiving facial beauty treatment (7) Others who acknowledge that doctors involved in the examination are not appropriate
Target sample size	21

Research contact person
Name of lead principal investigator	Toshiyuki Watanbe
Organization	Tokyo University of Agriculture and Technology
Division name	Graduate School of Engineering, Department of Applied Chemistry
Address	2-24-16 Nakacho, Koganei, Tokyo
TEL	042-388-7289
Email	toshi@cc.tuat.ac.jp

Public contact
Name of contact person	Miho Shimizu
Organization	Tokyo University of Agriculture and Technology
Division name	Grad Sch of Eng, Dept of Appl Chem
Address	2-24-16 Nakacho, Koganei, Tokyo
TEL	042-388-7539
Homepage URL
Email	mshmz@cc.tuat.ac.jp

Sponsor
Institute	Tokyo University of Agriculture and Technology
Institute
Department

Funding Source
Organization	Almado Co., 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	東京農工大学（東京都）

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 05 Month 31 Day
Anticipated trial start date	2015 Year 06 Month 04 Day
Last follow-up date	2015 Year 07 Month 30 Day
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	2015 Year 06 Month 04 Day
Last modified on	2017 Year 06 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020619