Impact of Continuous Defocused CO2 Laser Vaporisation on... | NCT02154607

Studies
Impact of Continuous Defocused CO2 Laser Vaporisation on the Histological Malignant Transformation of Erosive Oral Lichen Planus in Patients

NCT02154607

Sponsor

Technical University of Munich

Status

Completed

Last Update Posted

Jun 3, 2014Estimated

Enrollment

263Actual

Phase

Not Applicable

Conditions

Oral Lichen Planus

Interventions

CO2-Laser Treatment

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2004

Primary Completion Date

Nov 2011Actual

Completion Date

Dec 2013Actual

First Submitted Date

Mar 27, 2014

First Submission Date that Met QC Criteria

May 30, 2014

First Posted Date

Jun 3, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 30, 2014

Last Update Posted Date

Jun 3, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Oral Lichen Planus (OLP) is a common condition with its erosive variant occasionally presenting a management challenge to the clinician. In addition it can have debilitating consequences on the patients' quality of life. The malignant transformation of OLP has been well documented. The aims of this work were to measure the number of patients developing malignant transformationof OLP to squamous cell carcinoma (SCC) comparing patients undergoing traditional symptomatic treatments with those patients that were treated by CO2 laser from 2004 - 2011. Outcome measures were rated by incisional biopsy (histology Report).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

263Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Symptomatic treatment	No Intervention	Symptomatic analgetic Treatment only was performed without any Manipulation of OLP lesions.
CO2-Laser Treatment	Active Comparator	CO2-Laser Vaporisation was performed of OLP lesions under local anaesthesia.	Device: CO2-Laser Treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CO2-Laser Treatment	Device		CO2-Laser Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
stable disease of OLP (clinical observation)		1 year

Secondary Outcomes

Measure	Description	Time Frame
Development of oral cancer (histological report after incisional biopsy)		3 years

Other Outcomes

Measure	Description	Time Frame
Development of reccurrence of OLP (clinical observation)		3 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Oral lichen planus
Histological confirmation of diagnosis
Patient willing for treatment

Exclusion Criteria:

Patient just does not want to participate as control/study group

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017676	Lichen Planus, Oral
D012008	Recurrence
D009369	Neoplasms

Ancestor Terms

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D008010	Lichen Planus
D017512	Lichenoid Eruptions

Browse Leaves

Not provided

Browse Branches

Not provided