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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000013505
Receipt No. 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

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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
Institute Yasuhiro Fujisawa
Institute
Department

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
URL(English) 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


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