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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000038772
Receipt No. R000044191
Scientific Title Improvement of the skin quality through the application of glycogen
Date of disclosure of the study information 2019/12/04
Last modified on 2019/12/03

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Basic information
Public title Improvement of the skin quality through the application of glycogen(0.3%)
Acronym Improvement of the skin quality through the application of glycogen
Scientific Title Improvement of the skin quality through the application of glycogen
Scientific Title:Acronym Improvement of the skin quality through the application of glycogen
Region
Japan

Condition
Condition Healthy volunteer
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the improvement of the skin quality from using glycogen lotion or glycogen cream (0.3%)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Indexes for skin conditions (stratum corneum moisture content, transepidermal water loss) and questionnaire (water amount, drying)
Key secondary outcomes Lightness, spots, pores, moisture content, viscoelasticity, transepidermal water loss, wrinkles, questionnaire

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 placebo cosmetics (lotion or cream) continuously for 4 weeks
Interventions/Control_2 Apply test cosmetics (lotion or cream) continuously for 4 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
45 years-old <=
Age-upper limit
59 years-old >=
Gender Male and Female
Key inclusion criteria 1.Those who can strictly follow the usage
2.Japanese healthy men and women from 45 to 59 years old
3.Those who feel lack of elasticity or moisture
Key exclusion criteria 1.Those who have a medical history of allergies to cosmetics
2.Those who have received hormone replacement therapy
3.Those who are pregnant, breastfeeding, or have a possibility of pregnancy
4.Those who have experience in beauty treatment such as aesthetics that affect the test site
5.Those who consume alcohol excessively
6.Persons whose lifestyle may change during the test period (night work, long trip, etc.)
7.Those who had participated within 4 weeks or are participating in other clinical trials
8.Those who are determined to be unsuitable for this study by the person in charge of the study
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Hideki
Middle name
Last name Nishiura
Organization R&D Skin Research Center, Basic Reserch, Nihon Kolmar Co., Ltd.
Division name R&D Skin Research Center, Basic Reserch, Nihon Kolmar Co., Ltd.
Zip code 541-0042
Address 1-6-19, Imabashi, Chuo-ku, Osaka, Japan
TEL 06-6203-8520
Email nishiura@kolmar.co.jp

Public contact
Name of contact person
1st name Hiroko
Middle name
Last name Yatsuhashi
Organization Ezaki Glico Co., Ltd.
Division name Institute of Health Sciences
Zip code 555-8502
Address 4-6-5, Utajima, Nishiyodogawa-ku, Osaka, Japan
TEL 81-6-6477-8425
Homepage URL
Email hiroko.yatsuhashi@glico.com

Sponsor
Institute Glico Nutrition Co., Ltd.
Institute
Department

Funding Source
Organization Glico Nutrition Co., Ltd.
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 R&D Kashiwara Laboratory, Nihon Kolmar Co., Ltd.
Address 16-2, Enmyo-cho, Kashiwara-city, Osaka
Tel 072-977-9431
Email nob@kolmar.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 12 Month 04 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 20
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 No longer recruiting
Date of protocol fixation
2019 Year 11 Month 08 Day
Date of IRB
2019 Year 11 Month 08 Day
Anticipated trial start date
2019 Year 11 Month 08 Day
Last follow-up date
2019 Year 12 Month 06 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 12 Month 03 Day
Last modified on
2019 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044191

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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