UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019426 |
|---|---|
| Receipt number | R000022467 |
| Scientific Title | A study of dermatological efficacy after continuous application of topical product (BSL02-1509AYM) in human skin |
| Date of disclosure of the study information | 2015/10/30 |
| Last modified on | 2016/10/20 19:16:41 |
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Basic information
Public title
A study of dermatological efficacy after continuous application of topical product (BSL02-1509AYM) in human skin
Acronym
A study of dermatological efficacy after continuous application of topical product (BSL02-1509AYM) in human skin
Scientific Title
A study of dermatological efficacy after continuous application of topical product (BSL02-1509AYM) in human skin
Scientific Title:Acronym
A study of dermatological efficacy after continuous application of topical product (BSL02-1509AYM) in human skin
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of skin condition by stratum corneum water content, transepidermal water loss, skin pH, photo image in skin surface, skin color, analysis of lipidome and metaborome in horny cell layer, evaluation of vascular function after repeated application of topical product for 4 and 8 weeks
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of skin condition by stratum corneum water content, transepidermal water loss, skin pH, photo image in skin surface, skin color, analysis of lipidome and metaborome in horny cell layer, evaluation of vascular function after repeated application of topical product for 4 and 8 weeks
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Topical application of both test product and control product for 4weeks and 8weeks.
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male
Key inclusion criteria
1)Healthy males
2)Individuals who drink only a few cup of coffee per day
Key exclusion criteria
1)Individuals who have some skin diseases (atopic dermatitis and so on)
2)Individuals who have some skin troubles in applied positions
3)Individuals who already got dark skin with excessive sunburn
4)Individuals who play outdoor actions with excessive sunburn routinely
5)Individuals who apply cosmetics or drugs for beauty to target skins, and take drugs for improvement of fleck, age spot and suntan
6)Individuals who have some diseases (endocrine, liver, kidney, heart and blood pressure and so on), or have had some diseases until a month
7)Individuals who have some diseases (hypertension, cardiac disease, diabetes, Raynaud disease, rosacea, telangiectasia) or feel excessive sensitivity to cold
8)Individuals who have an abnormal cardiac rhythm
9)Individuals who usually take some medications
10)Individuals who got some cosmetic surgery/implant
11)Individuals who have or might have same dermatological diseases (pollen, rhinitis, and allergic dermatitis)
12)Individuals who have or might have same allergy of medicine
13)Smoker
14)Individuals who drink much coffee per day
15)Individuals who are judged inappropriate for the study by study director and/or study doctor
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takatoshi Murase |
Organization
Kao Corporation
Division name
R&D -Core Technology- Biological Science Research
Zip code
Address
2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, JAPAN
TEL
0285-68-7871
murase.takatoshi@kao.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuyuki Yuki |
Organization
Kao Corporation
Division name
R&D -Core Technology- Biological Science Research
Zip code
Address
2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, JAPAN
TEL
0285-68-7460
Homepage URL
yuki.katsuyuki@kao.co.jp
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
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
Address
Tel
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
花王株式会社（栃木県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 30 | 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
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 20 | Day |
Last modified on
| 2016 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022467
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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