UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008849 |
|---|---|
| Receipt number | R000010391 |
| Scientific Title | Clinical effects and safety of a CO2 laser vaporization for oral lichen planus, controlled clinical trial. |
| Date of disclosure of the study information | 2012/09/07 |
| Last modified on | 2012/09/04 19:41:23 |
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Basic information
Public title
Clinical effects and safety of a CO2 laser vaporization for oral lichen planus, controlled clinical trial.
Acronym
Clinical trial of CO2 laser vaporization therapy for oral lichen planus.
Scientific Title
Clinical effects and safety of a CO2 laser vaporization for oral lichen planus, controlled clinical trial.
Scientific Title:Acronym
Clinical trial of CO2 laser vaporization therapy for oral lichen planus.
Region
| Japan |
Condition
Condition
Oral lichen planus
Classification by specialty
| Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of effects and safety of a CO2 laser vaporization for oral lichen planus.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
clinical observation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
CO2 laser vaporization
Interventions/Control_2
No treatment
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
1 Oral lichen planus confirmed by histopathological examination.
2 The intractable case: for a least 1 month, conventional treatments for oral lichen planus has done and given no effect.
3 The patient feels trouble by pain of oral lichen planus.
Key exclusion criteria
The high risk case of critical complications induced by surgical therapy.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kousuke Matsumoto |
Organization
Kobe University Hospital
Division name
Department of Oral and Maxillofacial Surgery
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe-city
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kobe University Hospital
Division name
Department of Oral and Maxillofacial Surgery
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe-city,
TEL
Homepage URL
Sponsor or person
Institute
Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kobe University Hospital
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
| 2012 | Year | 09 | Month | 07 | 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
Preinitiation
Date of protocol fixation
| 2012 | Year | 09 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 10 | 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
| 2012 | Year | 09 | Month | 04 | Day |
Last modified on
| 2012 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010391
