UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047069 |
|---|---|
| Receipt number | R000053698 |
| Scientific Title | Validation of repellent material efficacy |
| Date of disclosure of the study information | 2022/03/04 |
| Last modified on | 2022/03/04 10:19:24 |
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Basic information
Public title
Validation of repellent material efficacy
Acronym
Validation of repellent material efficacy
Scientific Title
Validation of repellent material efficacy
Scientific Title:Acronym
Validation of repellent material efficacy
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm efficacy of repellent material for healthy adult forearm skin.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of biting inhibition of Aedes albopictus for human skin
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
Apply test samples for skin area (forearm 40 mg, 20 cm2),following insert forearm into mosquito cage for 10 min. The application is conducted three times per day. The test conducts 12 days.
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
| 30 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy human
Key exclusion criteria
1.People who experienced severe itchiness, swelling, pain by mosquito bites
2.People who experienced long term biting scar remaining.
3.People who experienced severe allergy by ethanol
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | Kohei |
| Middle name | |
| Last name | Takeuchi |
Organization
Kao Corporation
Division name
Personal health care Lab.
Zip code
131-8501
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
TEL
+81-3-5630-9461
takeuchi.kouhei@kao.com
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Takeuchi |
Organization
Kao Corporation
Division name
Personal health care Lab.
Zip code
131-8501
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
TEL
+81-3-5630-9461
Homepage URL
takeuchi.kouhei@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
| 2022 | Year | 03 | Month | 04 | 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
3
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
| 2022 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | 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
| 2022 | Year | 03 | Month | 04 | Day |
Last modified on
| 2022 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053698
