UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004180 |
|---|---|
| Receipt number | R000005021 |
| Scientific Title | A Clinical study for safety and practical use of vaccine device using microneedles |
| Date of disclosure of the study information | 2010/09/10 |
| Last modified on | 2012/05/07 20:54:49 |
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Basic information
Public title
A Clinical study for safety and practical use of vaccine device using microneedles
Acronym
A Clinical study for safety and practical use of vaccine device using microneedles
Scientific Title
A Clinical study for safety and practical use of vaccine device using microneedles
Scientific Title:Acronym
A Clinical study for safety and practical use of vaccine device using microneedles
Region
| Japan |
Condition
Condition
Flu
Classification by specialty
| Infectious disease | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
As a clinical study to check the safety and practical use of transcutaneous vaccine devices, self-degradating microneedles made of hyaluronic acid will be applied onto human skin of healthy volunteer. The microneedles do not contain any vaccine antigens in this study.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Transcutaneous vaccine devices with self-degradating microneedles will be used without harmful adverse effects. Petechia may be observed when microneedles break dermal capillary vessels.
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
Prevention
Type of intervention
| Vaccine |
Interventions/Control_1
20 healthy volunteers who agreed informed consent.
0.8 cm2 of 300 micrometer, 500 micrometer,800 micrometer length microneedles patches made of hyaluronic acid will be applied onto upper arm for 6 hours and will be removed. Application will be twice per volunteer.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
healthy volunteers who agreed informed consent
Key exclusion criteria
healthy volunteers who disagreed informed consent
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Azukizawa |
Organization
Osaka University, Graduate School of Medicine
Division name
Department of Dermatology
Zip code
Address
2-2, Yamadaoka, Suita, 565-0871 JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka University,Graduate School of Medicine
Division name
Department of Dermatology
Zip code
Address
TEL
06-6879-3031
Homepage URL
Sponsor or person
Institute
Osaka University, Graduate School of Medicine
Department of Dermatology
Institute
Department
Personal name
Funding Source
Organization
National Institute of Biochemical Innovation
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 09 | Month | 10 | 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
| 2010 | Year | 08 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 09 | Month | 09 | Day |
Last modified on
| 2012 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005021
