UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053173 |
|---|---|
| Receipt number | R000060655 |
| Scientific Title | Confirmation of changes in skin microflora and skin condition by application of bioglycogen |
| Date of disclosure of the study information | 2024/01/05 |
| Last modified on | 2023/12/20 11:49:41 |
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Basic information
Public title
Confirmation of changes in skin microflora and skin condition by application of bioglycogen
Acronym
Confirmation of changes in skin microflora and skin condition by application of bioglycogen
Scientific Title
Confirmation of changes in skin microflora and skin condition by application of bioglycogen
Scientific Title:Acronym
Confirmation of changes in skin microflora and skin condition by application of bioglycogen
Region
| Japan |
Condition
Condition
Healthy adult men and women
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine changes in skin microflora and skin condition when bioglycogen is applied.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin bacterial diversity index
Key secondary outcomes
Fluctuations in skin bacterial flora
Skin moisture content
Transepidermal water loss
Facial imaging analyses
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Apply the test product to one side of the face for 4 weeks.
Interventions/Control_2
The other side of the face will receive a placebo solution 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
| 30 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy men and women between the ages of 30 and 59
Key exclusion criteria
Those who are currently undergoing drug treatment for some disease.
Patients with a history of allergies to cosmetics
Patients undergoing hormone replacement therapy.
Those who have undergone or are undergoing cosmetic treatment that affects the face within the past 5 years.
Those who are currently using cosmetics that contain ingredients with known effects on the flora.
Those who are unable to refrain from special care during the study period (e.g., products for specific areas such as the corners of the eyes, packs, etc., not to be used every day).
Those who cannot refrain from taking beauty supplements, drinks, or vitamin supplements during the study period.
Pregnant and lactating mothers
Pets, pre-school children under 6 years old in the household
Those who are likely to make significant lifestyle changes during the study period.
Those who are participating in a study that involves the ingestion of other foods or the use of medications.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kohei |
| Middle name | |
| Last name | Kitaaki |
Organization
Glico Nutrition Co., Ltd.
Division name
Application R&D Center
Zip code
555-8502
Address
4-6-5, Utajima, Nishiyodogawa-Ku, Osaka, 555-8502, Japan
TEL
050-1744-4293
kohei.kitaaki@glico.com
Public contact
Name of contact person
| 1st name | Eri |
| Middle name | |
| Last name | Funahashi |
Organization
Glico Nutrition Co., Ltd.
Division name
Application R&D Center
Zip code
555-8502
Address
4-6-5, Utajima, Nishiyodogawa-Ku, Osaka, 555-8502, Japan
TEL
050-1744-4293
Homepage URL
eri.funahashi@glico.com
Sponsor or person
Institute
Glico Nutrition Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Glico Group Research Ethics Committee
Address
4-6-5, Utajima, Nishiyodogawa-Ku, Osaka, 555-8502, Japan
Tel
050-1745-4027
toshihiko.koike@glico.com
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
グリコ栄養食品株式会社（大阪府）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 05 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 12 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 29 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 20 | Day |
Last modified on
| 2023 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060655
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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