UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038773 |
|---|---|
| Receipt number | R000044190 |
| 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 | 2020/06/03 09:21:09 |
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Basic information
Public title
Improvement of the skin quality through the application of glycogen(0.5%)
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 (0.5%)
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
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
hiroko.yatsuhashi@glico.com
Sponsor or person
Institute
Glico Nutrition Co., Ltd.
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2019 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 05 | 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
| 2020 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044190
