UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033691 |
|---|---|
| Receipt number | R000038382 |
| Scientific Title | Effect of treatment with plant extracts on skin properties |
| Date of disclosure of the study information | 2018/08/20 |
| Last modified on | 2019/03/29 12:53:36 |
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Basic information
Public title
Effect of treatment with plant extracts on skin properties
Acronym
Effect of treatment with plant extracts on skin properties
Scientific Title
Effect of treatment with plant extracts on skin properties
Scientific Title:Acronym
Effect of treatment with plant extracts on skin properties
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of treatment with plant extract on expression of antimicrobial peptide and bactericidal action in healthy human skin
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Indices with regard to skin barrier; expression level of antimicrobial peptide and bactericidal action
Key secondary outcomes
Indices with regard to skin conditions; skin physiological parameters such as skin conductance and TEWL
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
8
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Apply test product A to the left palm and medial forearm, and placebo to the right palm and medial forearm, twice a day for 7 days in the first half investigation. After washout period of 3 weeks, apply test product B to the left palm and medial forearm, and placebo to the right palm and medial forearm, twice a day for 7 days, in the second half investigation.
Interventions/Control_2
Apply test product A to the left palm and medial forearm, and placebo to the right palm and medial forearm, twice a day for 7 days in the first half investigation. After washout period of 3 weeks, apply placebo to the left palm and medial forearm, and test product B to the right palm and medial forearm, twice a day for 7 days, in the second half investigation.
Interventions/Control_3
Apply placebo to the left palm and medial forearm, and test product A to the right palm and medial forearm, twice a day for 7 days in the first half investigation. After washout period of 3 weeks, apply test product B to the left palm and medial forearm, and placebo to the right palm and medial forearm, twice a day for 7 days, in the second half investigation.
Interventions/Control_4
Apply placebo to the left palm and medial forearm, and test product A to the right palm and medial forearm, twice a day for 7 days in the first half investigation. After washout period of 3 weeks, apply placebo to the left palm and medial forearm, and test product B to the right palm and medial forearm, twice a day for 7 days, in the second half investigation.
Interventions/Control_5
Apply test product B to the left palm and medial forearm, and placebo to the right palm and medial forearm, twice a day for 7 days in the first half investigation. After washout period of 3 weeks, apply test product A to the left palm and medial forearm, and placebo to the right palm and medial forearm, twice a day for 7 days, in the second half investigation.
Interventions/Control_6
Apply test product B to the left palm and medial forearm, and placebo to the right palm and medial forearm, twice a day for 7 days in the first half investigation. After washout period of 3 weeks, apply placebo to the left palm and medial forearm, and test product A to the right palm and medial forearm, twice a day for 7 days, in the second half investigation.
Interventions/Control_7
Apply placebo to the left palm and medial forearm, and test product B to the right palm and medial forearm, twice a day for 7 days in the first half investigation. After washout period of 3 weeks, apply test product A to the left palm and medial forearm, and placebo to the right palm and medial forearm, twice a day for 7 days, in the second half investigation.
Interventions/Control_8
Apply placebo to the left palm and medial forearm, and test product B to the right palm and medial forearm, twice a day for 7 days in the first half investigation. After washout period of 3 weeks, apply placebo to the left palm and medial forearm, and test product A to the right palm and medial forearm, twice a day for 7 days, in the second half investigation.
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 49 | years-old | >= |
Gender
Male
Key inclusion criteria
1.Informed consent provided
2.Able to follow the instruction of the study team
Key exclusion criteria
1.Subjects with injury such as wound or eczema on hands or forearms
2.Subjects with severe sunburn on hands or forearms
3.Subjects with atopic dermatitis or contact skin hypersensitivity
4.Subjects who need a routine visit to a clinic or regular medication
5.Subjects who participate in other research or treatment with physical loads that affect this test
6.Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuya Mori |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7769
mori.takuya@kao.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeyuki Ono |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7687
Homepage URL
ono.shigeyuki@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
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
| 2018 | Year | 08 | Month | 20 | 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 | 06 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 21 | 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 | 08 | Month | 09 | Day |
Last modified on
| 2019 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038382
