UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009451 |
|---|---|
| Receipt number | R000011105 |
| Scientific Title | Ex vivo characteristic assessment of transcutaneous vaccine device by using human skin samples (age-comparison) |
| Date of disclosure of the study information | 2012/12/01 |
| Last modified on | 2013/12/17 14:27:33 |
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Basic information
Public title
Ex vivo characteristic assessment of transcutaneous vaccine device by using human skin samples (age-comparison)
Acronym
Ex vivo characteristic assessment of transcutaneous vaccine device by using human skin samples (age-comparison)
Scientific Title
Ex vivo characteristic assessment of transcutaneous vaccine device by using human skin samples (age-comparison)
Scientific Title:Acronym
Ex vivo characteristic assessment of transcutaneous vaccine device by using human skin samples (age-comparison)
Region
| Japan |
Condition
Condition
Flu
Classification by specialty
| Infectious disease | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the antigen delivery of transcutaneous vaccine devices, self-degradating microneedles secreting fluorescence-labeled antigen will be applied onto human skin samples ex vivo. Cryosections of applied skin sample will be made to clarify the depth of antigen delivery. In addition, purified antigen presenting cells and keratinocytes from human skin samples will be used for in vitro assay to check the vaccine effects on immune cells.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Antigen delivery mechanisms by microneedles will be elucidated in human skin by ex vivo studies.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Patients who will be performed skin surgery from December 2012 to March 2014 and who provide approximately 2 square meter surplus skin once
age: 5-15y.o.
Interventions/Control_2
Patients who will be performed skin surgery from December 2012 to March 2014 and who provide approximately 2 square meter surplus skin once
age: 16-40y.o.
Interventions/Control_3
Patients who will be performed skin surgery from December 2012 to March 2014 and who provide approximately 2 square meter surplus skin once
age:41-65y.o.
Interventions/Control_4
Patients who will be performed skin surgery from December 2012 to March 2014 and who provide approximately 2 square meter surplus skin once
age:>65y.o.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 5 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient who agreed informed consent to provide surplus skin during skin surgery
Key exclusion criteria
Patient who disagreed informed consent to provide surplus skin during skin surgery
Target sample size
12
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
06-6879-3031
azukizaw@derma.med.osaka-u.ac.jp
Public contact
Name of contact person
| 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
06-6879-3031
Homepage URL
azukizaw@derma.med.osaka-u.ac.jp
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
| 2012 | Year | 12 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 03 | 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
| 2012 | Year | 12 | Month | 01 | Day |
Last modified on
| 2013 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011105
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
