UMIN-CTR Clinical Trial

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