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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011515
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Juntendo University School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013472

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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