UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013209 |
|---|---|
| Receipt number | R000015397 |
| Scientific Title | Clinical trial for efficacy and safety three-microniddle device to the intradermal injection |
| Date of disclosure of the study information | 2014/02/21 |
| Last modified on | 2014/02/24 15:24:23 |
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Basic information
Public title
Clinical trial for efficacy and safety three-microniddle device to the intradermal injection
Acronym
Clinical trial of three-microniddle device
Scientific Title
Clinical trial for efficacy and safety three-microniddle device to the intradermal injection
Scientific Title:Acronym
Clinical trial of three-microniddle device
Region
| Japan |
Condition
Condition
Superficial skin disease
Classification by specialty
| Plastic surgery | Aesthetic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of efficacy and safety in the local anesthesia using three microneedle
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of pain and anesthetic range
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
injector ordinarily used (31G)
intradermal injection of 1% lidocaine which contained epinephrine/0.1ml
Interventions/Control_2
three-microneedle device (31G)
intradermal injection of 1% lidocaine which contained epinephrine/0.1ml
Interventions/Control_3
three-microneedle device (31G)
intradermal injection of 1% lidocaine which contained epinephrine/0.1ml
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who need local anesthesia on the treatment for superficial skin disease
Key exclusion criteria
1. minority under 20 years of age
2. Elderly person 60 years or older
3. Patient taking antithrombotic drug and/or anticoagulant
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshimura Kotaro |
Organization
University of Tokyo School of Medicine
Division name
Plastic Surgery
Zip code
Address
7-3-1, Hongo, Bunkyo-Ku, Tokyo 113-8655, Japan
TEL
03-5800-8948
kotaro-yoshimura@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Kanayama |
Organization
University of Tokyo School of Medicine
Division name
Plastic Surgery
Zip code
Address
7-3-1, Hongo, Bunkyo-Ku, Tokyo 113-8655, Japan
TEL
03-5800-8949
Homepage URL
kk0519@hotmail.co.jp
Sponsor or person
Institute
Department of Plastic Surgery, University of Tokyo School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nanbu Plastics Co.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 02 | Month | 21 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 03 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 08 | 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
| 2014 | Year | 02 | Month | 21 | Day |
Last modified on
| 2014 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015397
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
