UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of wrinkle improvement and skin symptom improvement effect by application of serum G
Acronym	Anti-wrinkle and skin symptom improvement test of serum G
Scientific Title	Evaluation of wrinkle improvement and skin symptom improvement effect by application of serum G
Scientific Title:Acronym	Anti-wrinkle and skin symptom improvement test of serum G
Region	Japan

Condition
Condition	Healthy adult female
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of wrinkle improvement and skin symptom improvement effect by application of serum G
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of Wrinkle Grade and skin condition
Key secondary outcomes	Not applicable

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Apply serum G to the designated left or right half face during eight 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	35 years-old <=
Age-upper limit	50 years-old >=
Gender	Female
Key inclusion criteria	Subjects whose wrinkle class in the outer corner is 1 to 3
Key exclusion criteria	1) The person who have a history of allergy to cosmetics. 2) The person undergoing hormone replacement therapy. 3) The person who have experienced cosmetic care that will affect the test site. 4) The person currently attending dermatology department 5) The person who may be pregnant or may be pregnant, and those who are breastfeeding 6) The person participating in other clinical trials 7) The person who eyelids are cramped when lightly closing eyes 8) Individuals who acknowledge that doctors involved in the examination are not appropriate.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Hiroki Middle name Last name Kaneko
Organization	Nichirei Biosciences INC.
Division name	Functional Materials
Zip code	104-8402
Address	6-19-20, Tsukiji, Chuo-ku, Tokyo
TEL	03-3248-2207
Email	kanekohrk@nichirei.co.jp

Public contact
Name of contact person	1st name Hiroki Middle name Last name Kaneko
Organization	Nichirei Biosciences INC.
Division name	Functional Materials
Zip code	104-8402
Address	6-19-20, Tsukiji, Chuo-ku, Tokyo
TEL	03-3248-2207
Homepage URL
Email	kanekohrk@nichirei.co.jp

Sponsor
Institute	SOUKEN
Institute
Department

Funding Source
Organization	Nichirei Biosciences INC.
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	Nichirei Biosciences INC.
Address	6-19-20, Tsukiji, Chuo-ku, Tokyo
Tel	03-3248-2207
Email	kanekohrk@nichirei.co.jp

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	2019 Year 03 Month 01 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	2019 Year 01 Month 15 Day
Date of IRB	2019 Year 03 Month 08 Day
Anticipated trial start date	2019 Year 02 Month 27 Day
Last follow-up date	2019 Year 07 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 02 Month 20 Day
Last modified on	2019 Year 07 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040950