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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032546
Receipt No. R000037120
Scientific Title A Study on the dermatological efficacy of KB extracts for dry skin
Date of disclosure of the study information 2018/05/15
Last modified on 2018/05/15

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Basic information
Public title A Study on the dermatological efficacy of KB extracts for dry skin
Acronym Efficacy test of KB extracts for skin
Scientific Title A Study on the dermatological efficacy of KB extracts for dry skin
Scientific Title:Acronym Efficacy test of KB extracts for skin
Region
Japan

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

Objectives
Narrative objectives1 To confirm the dermatological efficacy of KB extracts for healthy female skin
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of the stinging test value after the application for 2 weeks with KB extract contain skin care products
Key secondary outcomes Evaluation of the water content, the trans-epidermal water loss and the dermatological assessment after the application for 2 weeks with KB extract contain skin care products

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 NO
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Apply the K extract contain skin care product for face twice a day for 2 weeks
Interventions/Control_2 Apply the B extract contain skin care product for face twice a day for 2 weeks
Interventions/Control_3 Apply the placebo skin care product for face twice a day for 2 weeks
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 Female
Key inclusion criteria Healthy females
Key exclusion criteria -Pregnancies and lactations
-Subjects with atopic dermatitis, eczema and pollen allergy
-Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takafumi Nishijima
Organization Kao Corporation
Division name Safety Science Research
Zip code
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL +81-285-68-7520
Email nishijima.takafumi@kao.com

Public contact
Name of contact person
1st name
Middle name
Last name Rie Ninomiya
Organization Kao Corporation
Division name Safety Science Research
Zip code
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL +81-285-68-7520
Homepage URL
Email ninomiya.rie@kao.com

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 Interface Ink.
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 H30-022
Org. issuing International ID_1 Interface, Ink.
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions インターフェイス株式会社(秋田県)

Other administrative information
Date of disclosure of the study information
2018 Year 05 Month 15 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 No longer recruiting
Date of protocol fixation
2018 Year 04 Month 25 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 15 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
2018 Year 05 Month 10 Day
Last modified on
2018 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037120

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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