NCT02154607

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
263

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2004

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 3, 2014

Completed
Last Updated

June 3, 2014

Status Verified

May 1, 2014

Enrollment Period

7.8 years

First QC Date

March 27, 2014

Last Update Submit

May 30, 2014

Conditions

Oral Lichen Planus

Keywords

oral lichen planusrecurrenceTreatmentcancerPrimary disease Management

Outcome Measures

Primary Outcomes (1)

  • stable disease of OLP (clinical observation)

    1 year

Secondary Outcomes (1)

  • Development of oral cancer (histological report after incisional biopsy)

    3 years

Other Outcomes (1)

  • Development of reccurrence of OLP (clinical observation)

    3 years

Study Arms (2)

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

CO2-Laser TreatmentDEVICE
CO2-Laser Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Oral lichen planus
  • Histological confirmation of diagnosis
  • Patient willing for treatment

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lichen Planus, OralRecurrenceNeoplasms

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesLichen PlanusLichenoid EruptionsSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2014

First Posted

June 3, 2014

Study Start

January 1, 2004

Primary Completion

November 1, 2011

Study Completion

December 1, 2013

Last Updated

June 3, 2014

Record last verified: 2014-05