UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039776 |
|---|---|
| Receipt number | R000045366 |
| Scientific Title | Effects of honeybee products for Skin Conditions: study 2 |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2021/03/11 09:15:12 |
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Basic information
Public title
Effects of honeybee products for Skin Conditions: study 2
Acronym
Effects of honeybee products for Skin Conditions: study 2
Scientific Title
Effects of honeybee products for Skin Conditions: study 2
Scientific Title:Acronym
Effects of honeybee products for Skin Conditions: study 2
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of honeybee products for Skin Conditions.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
skin moisture content
Key secondary outcomes
1)Indexes for skin conditions
(Transepidermal water loss, skin viscoelasticity, the surface texture, visual evaluation)
2)Skin questionnaire (Visual Analogue Scale)
3)Safety evaluation (Doctor's questions)
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
Apply test cosmetics (lotion) to the designated left or right half face during 4 weeks.
Interventions/Control_2
Apply placebo cosmetics (lotion) to the designated left or right half face during 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
1) Japanese males and females aged 30-59 years.
2) Subjects with water content value of 25-40 on both cheeks.
3) Subjects can understand and comply with the rules written in protocol during clinical study period.
4) Subjects whose written informed consent has been obtained.
5) Subjects judged appropriate for the study by the principal.
Key exclusion criteria
The following exclusion criteria apply to subjects.
1) Constantly use cosmetic that contain the ingredient involved in this study.
2) With any allergies.
3) Visit dermatology department(for the purpose of treating atopic dermatitis etc.).
4) With strange skin conditions at measurement points.
5) Conducting hormone replacement therapy.
6) Have ave got cosmetic surgery which would affect the targeted skin.
7) Will get sunburned during the test period.
8) Will receive special treatment (facial esthetics, epilation etc.) during the test period.
9) Can not continue regular life.
10) Have an irregular habit because of working at night or working under work-shift form.
11) Drinks more than 500 ml beer daily.
12) A smoker.
13) Participated in other clinical trial within last 3 months.
14) Working at the health food, cosmetics or pharmaceutical company.
15) Judged not appropriate by principal.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kayoko |
| Middle name | |
| Last name | Numano |
Organization
Numano Clinic
Division name
Not applicable
Zip code
370-0815
Address
15 Yanagawacho, Takasaki-shi, Gunma 370-0815 Japan
TEL
027-322-2926
sakurai@inforward.co.jp
Public contact
Name of contact person
| 1st name | Chizuru |
| Middle name | |
| Last name | Homma |
Organization
Yamada Bee Company, Inc.
Division name
Functional research section, Institute for Bee Products & Health Science, R&D department
Zip code
708-0393
Address
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan
TEL
0868-54-3825
Homepage URL
ch1644@yamada-bee.com
Sponsor or person
Institute
Yamada Bee Company, Inc.
Institute
Department
Personal name
Funding Source
Organization
Yamada Bee Company, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Research Center for Immunological Analysis, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
General Incorporated Association Clinical Research Review Centers
Address
2972-8-603 Ishikawacho, Hachiouji-shi, Tokyo
Tel
090-3547-6398
crrctakashima@kpd.biglobe.ne.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
| 2020 | Year | 10 | Month | 01 | 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
35
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
| 2020 | Year | 03 | Month | 04 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 11 | Day |
Last modified on
| 2021 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045366
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