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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019152
Receipt No. R000022144
Scientific Title A study of dermatological efficacy of topical product(BSL02-150929Y) in human skin
Date of disclosure of the study information 2015/10/23
Last modified on 2016/09/29

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Basic information
Public title A study of dermatological efficacy of topical product(BSL02-150929Y) in human skin
Acronym A study of dermatological efficacy of topical product(BSL02-150929Y) in human skin
Scientific Title A study of dermatological efficacy of topical product(BSL02-150929Y) in human skin
Scientific Title:Acronym A study of dermatological efficacy of topical product(BSL02-150929Y) in human skin
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Dermatology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Dermatological efficacy of erythema formation against UVR by application of topical product
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Following 2 weeks application of skin care preparations to upper arms,
I. Degree of erythema 1 day after UVB irradiation.
II. Skin color 1 week after UVB irradiation.
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 1) Topical application of both test product and control product for 3wks.
2) UVB irradiation to applied areas after 2wks application
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 Healthy males
Key exclusion criteria 1)Individuals who have some skin diseases
2)Individuals who have some skin troubles in applied positions
3)Individuals who already get dark skin with excessive sunburn
4)Individuals who play outdoor actions with excessive sunburn routinely
5)Individuals who have some diseases (endocrine, liver, kidney, heart and blood pressure and so on) and administer treatments and medications
6)Individuals who apply cosmetics and drugs for beauty to target skins, and take drugs for improvement of fleck, age spot and suntan
7)Smoker
8)Individuals who are judged inappropriate for the study by study director and/or study doctor
Target sample size 10

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
Email 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
Email yuki.katsuyuki@kao.co.jp

Sponsor
Institute Kao Corporation
Institute
Department

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
Email

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 花王株式会社栃木事業場生理機能棟(栃木県)

Other administrative information
Date of disclosure of the study information
2015 Year 10 Month 23 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 06 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 09 Month 29 Day
Last modified on
2016 Year 09 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022144

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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