UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003908 |
|---|---|
| Receipt number | 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 17:01:12 |
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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
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
ozawa@med.osaka-cu.ac.jp
Sponsor or person
Institute
Department of Plastic and Reconstructive Surgery, Osaka City University, Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004699
