UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011515 |
|---|---|
| Receipt number | R000013472 |
| Scientific Title | Comparative investigation of clinical utility of EMLA cream and lidocaine tape at laser therapy |
| Date of disclosure of the study information | 2013/08/19 |
| Last modified on | 2019/09/14 20:36:10 |
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Basic information
Public title
Comparative investigation of clinical utility of EMLA cream and lidocaine tape at laser therapy
Acronym
Comparative investigation of clinical utility of EMLA cream and lidocaine tape at laser therapy
Scientific Title
Comparative investigation of clinical utility of EMLA cream and lidocaine tape at laser therapy
Scientific Title:Acronym
Comparative investigation of clinical utility of EMLA cream and lidocaine tape at laser therapy
Region
| Japan |
Condition
Condition
Angioma, nevus, mole, seborrheic keratosis, senile lentigo, tattoo
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the anesthetic efficacy of EMLA cream and lidocaine tape by use of half side test
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
VAS
Key secondary outcomes
Questionnaire survey
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A half side test of EMLA cream and lidocaine tape
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
| 15 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who have angioma, nevus, tattoo, mole, seborrheic keratosis, or senile lentigo. Patients who was diagnosed to receive laser therapy
Patients who obtained the document voluntary consent of the patient himself after receiving a sufficient explanation upon participation in this study , on a full understanding
Key exclusion criteria
Patients who have allergy of Anilide anesthetic
Patients who have alcoholism or drug addiction
Patients who have liver disease, kidney disease, or heart disease
Patients who have eczema, dermatitis or scar at the region that will be applied investigational drugs
Patients who received medication that affect drug evaluation (example; topical anesthesia, general anesthesia, sedative, anxiolytic, antipyretic analgesic, corticosteroid, antipruritic drug, convergence drug, opium alkaloid drug, coca alkaloid drug, Synthetic narcotics )
Patients who is desensitization
Patients who participated in other clinical study within 6 months before this study
Patients who is participating other clinical study at present
Patients who have already participated in this study
Patients who is pregnant or lactating
Patients whom the doctor responsible for this study judged unfit for this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Mizuno |
Organization
Juntendo University School of Medicine
Division name
Department of Plastic and Reconstructive Surgery
Zip code
Address
2-1-1 Hongo Bunkyo-ku Tokyo
TEL
03-3813-3111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rica Tanaka |
Organization
Juntendo University School of Medicine
Division name
Department of Plastic and Reconstructive surgery
Zip code
Address
2-1-1 Hongo Bunkyo-ku Tokyo
TEL
Homepage URL
Sponsor or person
Institute
Juntendo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Juntendo University School of medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Seisho Hospital
Name of secondary funder(s)
none
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
順天堂大学医学部付属順天堂医院（東京都）Juntendo university hospital(Tokyo)
西湘病院（神奈川県） Seisho hospital(Kanagawa)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 19 | 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 | 08 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 19 | Day |
Last modified on
| 2019 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013472
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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