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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000003908
Receipt No. R000004699
Scientific Title Hair removal with the Microtia by GentleLASE
Date of disclosure of the study information 2010/07/30
Last modified on 2014/02/19

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Basic information
Public title Hair removal with the Microtia by GentleLASE
Acronym Hair removal with the Microtia by GentleLASE
Scientific Title Hair removal with the Microtia by GentleLASE
Scientific Title:Acronym Hair removal with the Microtia by GentleLASE
Region
Japan

Condition
Condition microtia
Classification by specialty
Plastic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Hair removal with the microtia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes We compare the auricular photograph which was taken after laser therapy with the one which was taken before hair removal.We evaluate them three months after last treatment.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 We do shaving of auricular hair and apply a lidocaine cream anesthetic agent to auricula.
30 minutes later, we irradiate pilose part in output 8J/cm2, pulse duration 3msec, spot size 18mm, DCDon with gentleLASE.
We apply ointment to an affected part after hair removal.We repeat above five times every two months.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients with microtia
Key exclusion criteria Patient who refused participation in this study
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiyuki Ozawa
Organization Osaka City University
Division name Department of Plastic and Reconstructive Surgery
Zip code
Address Asahi 1-4-3, Abeno, Osaka
TEL 06-6645-3892
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toshiyuki Ozawa
Organization Osaka City University
Division name Department of Plastic and Reconstructive Surgery
Zip code
Address Asahi 1-4-3, Abeno, Osaka
TEL 06-6645-3892
Homepage URL
Email ozawa@med.osaka-cu.ac.jp

Sponsor
Institute Department of Plastic and Reconstructive Surgery, Osaka City University, Graduate School of Medicine
Institute
Department

Funding Source
Organization none
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
2010 Year 07 Month 30 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 Enrolling by invitation
Date of protocol fixation
2009 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 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
2010 Year 07 Month 13 Day
Last modified on
2014 Year 02 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004699

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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