UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000008849
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email

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
Email

Sponsor
Institute Kobe University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010391


Contact us.