UMIN-CTR Clinical Trial

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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