UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032546 |
|---|---|
| Receipt number | 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 | 2020/11/11 11:57:08 |
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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
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
ninomiya.rie@kao.com
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
Interface Ink.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Completed
Date of protocol fixation
| 2018 | Year | 04 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
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
| 2020 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037120
