UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study of dermatological efficacy after continuous application of topical product (BSL02-1509AYM) in human skin
Title of the study (Brief title)	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	Takatoshi Murase
Organization	Kao Corporation
Division name	R&D -Core Technology- Biological Science Research
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	Katsuyuki Yuki
Organization	Kao Corporation
Division name	R&D -Core Technology- Biological Science Research
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022467