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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Healthy volunteer | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |