UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037998 |
|---|---|
| Receipt number | R000043316 |
| Scientific Title | A home use test to verify the ceramide retention capacity of shampoos |
| Date of disclosure of the study information | 2019/09/13 |
| Last modified on | 2020/02/03 12:52:51 |
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Basic information
Public title
A home use test to verify the ceramide retention capacity of shampoos
Acronym
A home use test of shampoos
Scientific Title
A home use test to verify the ceramide retention capacity of shampoos
Scientific Title:Acronym
A home use test of shampoos
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the mildness of shampoos on scalp
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the amount change of ceramide in the scalp stratum corneum before and after use of shampoos for 4 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
Treatment
Type of intervention
| Other |
Interventions/Control_1
Use 2 kinds of shampoo on head once a day for 4 weeks
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
-Healthy males and females who work in Kao Sumida office
-Subjects who have consciousness of drying sensitive skin
-Subjects who can participate in this study for 28 uninterrupted days
-Subjects who can accommodate restrictions (prohibition of hair coloring, bleaching, perm in a week before the day of Lab Visit)
-Subjects who can provide consent on a voluntary basis before this study starts
Key exclusion criteria
-Subjects with suspected skin allergy, cutaneous hypersensitivity
-Subjects who could cause skin allergy by shampoo
-Subjects with external injury, surgical treatments
-Subjects with atopic dermatitis, seborrheic dermatitis
- Subjects with highly exposed to sun light
Subjects whose hair was chemically treated in a week before the start of this study
-Pregnancies
-Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Yoshida |
Organization
Kao Corporation
Division name
Hair Care Products Research
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-9872
yoshida.hiroshi1@kao.com
Public contact
Name of contact person
| 1st name | Atsuko |
| Middle name | |
| Last name | Ebato |
Organization
Kao Corporation
Division name
Hair Care Products Research
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-9872
Homepage URL
ebato.atsuko@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
Human Research Ethics Committee, Kao corporation
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
Tel
+81-3-5630-7263
morisaki.naoko@kao.com
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（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 13 | 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
30
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
| 2019 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 02 | Month | 03 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 12 | Day |
Last modified on
| 2020 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043316
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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