UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004134
Receipt No. R000004964
Scientific Title Ex vivo characteristic assessment of transcutaneous vaccine device by using human skin samples
Date of disclosure of the study information 2010/09/01
Last modified on 2012/12/01

* 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 Ex vivo characteristic assessment of transcutaneous vaccine device by using human skin samples
Acronym Ex vivo characteristic assessment of transcutaneous vaccine device by using human skin samples
Scientific Title Ex vivo characteristic assessment of transcutaneous vaccine device by using human skin samples
Scientific Title:Acronym Ex vivo characteristic assessment of transcutaneous vaccine device by using human skin samples
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 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 Educational,Counseling,Training
Type of intervention
Maneuver
Interventions/Control_1 Patients who will be performed skin surgery from September 2010 to March 2011 and who provide approximately 2 square meter surplus skin once
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 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 5

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
Email

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
Email

Sponsor
Institute Osaka University, Graduate School of Medicine
Department of Dermatology
Institute
Department

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
Email

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 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 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
2012 Year 10 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 08 Month 31 Day
Last modified on
2012 Year 12 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004964

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.