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


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 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


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

Value
https://center6.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