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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004180
Receipt No. 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

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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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005021

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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