UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013505
Receipt number R000015722
Scientific Title Study of evaluating the efficacy of microneedle may reduce the injection pain of the melanoma patinet receiving interferon-beta as an adjuvant therapy
Date of disclosure of the study information 2014/04/01
Last modified on 2015/09/25 09:56:38

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Basic information

Public title

Study of evaluating the efficacy of microneedle may reduce the injection pain of the melanoma patinet receiving interferon-beta as an adjuvant therapy

Acronym

interferon and microneedle

Scientific Title

Study of evaluating the efficacy of microneedle may reduce the injection pain of the melanoma patinet receiving interferon-beta as an adjuvant therapy

Scientific Title:Acronym

interferon and microneedle

Region

Japan


Condition

Condition

Melanoma patient receiving intradermal injection of interferon-beta as adjuvant therapy

Classification by specialty

Dermatology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to evaluate the pain reduction efficacy of using microneedle when injecting interferon-beta intradermally

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Visual analogue scale

Key secondary outcomes



Base

Study type


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Single blind -participants are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Using 34G microneedle

Interventions/Control_2

29G insulin injector

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

90 years-old >

Gender

Male and Female

Key inclusion criteria

Patient using interferon-beta as an adjuvant therapy of malignant melanoma

Key exclusion criteria

none

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasuhiro Fujisawa

Organization

University of Tsukuba

Division name

Dermatology

Zip code


Address

1-1-1Tennodai, Tsukbua city

TEL

0298533128

Email

fujisan@md.tsukuba.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yasuhiro Fujisawa

Organization

University of Tsukuba

Division name

Dermatology

Zip code


Address

1-1-1Tennodai, Tsukbua city

TEL

0298533128

Homepage URL


Email

fujisan@md.tsukuba.ac.jp


Sponsor or person

Institute

Yasuhiro Fujisawa

Institute

Department

Personal name



Funding Source

Organization

University of Tsukuba

Organization

Division

Category of Funding Organization

Self funding

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

2014 Year 04 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


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

2014 Year 03 Month 12 Day

Date of IRB


Anticipated trial start date

2014 Year 04 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2014 Year 12 Month 30 Day


Other

Other related information



Management information

Registered date

2014 Year 03 Month 25 Day

Last modified on

2015 Year 09 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015722


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name