UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035954
Receipt No. R000040950
Scientific Title Evaluation of wrinkle improvement and skin symptom improvement effect by application of serum G
Date of disclosure of the study information 2019/03/01
Last modified on 2019/07/26

* 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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.