UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038248 |
|---|---|
| Receipt number | R000043599 |
| Scientific Title | A home use test to verify the safety of cleaning cosmetic |
| Date of disclosure of the study information | 2019/11/01 |
| Last modified on | 2020/02/03 12:53:54 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A home use test of shampoo
Acronym
A home use test of shampoo
Scientific Title
A home use test to verify the safety of cleaning cosmetic
Scientific Title:Acronym
A home use test of shampoo
Region
| Japan |
Condition
Condition
Healthy child
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the safety of shampoo on scalp
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation for the absence of scalp trouble after use of shampoo for 2 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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Use a shampoo on head once a day for 2 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
| 3 | months-old | <= |
Age-upper limit
| 24 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
Subject1:Child
-Healthy children (males and females) who live in Tokyo and surrounding areas
-Subjects who can visit Lab for consent and evaluations with their parent
-Subjects who wash their head with shampoo or body cleanser (include products for baby)
Subject2:Parent
-Subjects who can provide consent on a voluntary basis before this study starts
-Subjects who can wash their child's head with test sample
-Subjects who can visit Lab for consent and evaluations with their child
Key exclusion criteria
Subject1:Child
-Subjects who are under treatment for diseases
-Subjects with external injury, eczema or sudamen which could affect the evaluation in the test
-Subjects with allergy disease including atopic dermatitis
-Subjects who have caused skin allergy or hypersensitiveness by shampoo or body cleanser
-Subjects who have participated in other tests for shampoo or body cleanser in 3 months
-Subjects deemed inappropriate to participate in this study by the principle investigator
Subject2:Parent
-Subjects with external injury, eczema or sudamen on hands and it could affect the evaluation in the test
-Subjects who have caused skin allergy or hypersensitiveness by shampoo or body cleanser
-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 | Amane |
| Middle name | |
| Last name | Kanai |
Organization
Shiba palace clinic
Division name
Dermatology
Zip code
105-0013
Address
DaiwaA Hamamatsucho Building 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL
+81-3-5408-1590
jimukyoku@mail.souken-r.com
Public contact
Name of contact person
| 1st name | Azusa |
| Middle name | |
| Last name | Kouno |
Organization
SOUKEN
Division name
Secretariat Division
Zip code
105-0013
Address
DaiwaA Hamamatsucho Building 3F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL
+81-3-5408-1555
Homepage URL
a_kouno@mail.souken-r.com
Sponsor or person
Institute
SOUKEN
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
株式会社SOUKEN（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | Month | 01 | 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
20
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 | 11 | Month | 05 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | 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 | 10 | Month | 09 | 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=R000043599
