Photodynamic Therapy for Oral Precursor Lesions | NCT01497951

Studies
Photodynamic Therapy for Oral Precursor Lesions

NCT01497951

Sponsor

Medical University of Vienna

Status

Completed

Last Update Posted

May 17, 2017Actual

Enrollment

28Actual

Phase

Phase 3

Conditions

Leukoplakia
Lichen

Interventions

Aminolaevulinic acid
Methylcellulose Placebo

Countries

Austria

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 2017

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

May 2011

Primary Completion Date

Jan 2017Actual

Completion Date

Jan 2017Actual

First Submitted Date

Dec 9, 2011

First Submission Date that Met QC Criteria

Dec 22, 2011

First Posted Date

Dec 23, 2011Estimated

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 16, 2017

Last Update Posted Date

May 17, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dvorak Gabriella, Univ.Ass.DDr., senior staff at department of oral surgery, Medical University of ViennaPrincipal Investigator

Lead Sponsor

Medical University of ViennaOTHER

Collaborators

Not provided

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

Pre-malignant lesions are difficult to treat. Even after surgical removal they tend to re-appear. Often the lesions are to large and are apparent on many sites, therefore surgical removal is not always possible. The photodynamic therapy uses a special substance, which is absorbed in cells, and thereafter activated by a defined light. The aim of this study is to compare the photodynamic therapy in potentially malignant lesions to a placebo. The investigators assume a significant better result in photodynamic therapy then treatment with a placebo.

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Aminolaevulinic acid	Experimental		Other: Aminolaevulinic acid
Placebo	Placebo Comparator		Other: Methylcellulose Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aminolaevulinic acid	Other	Photodynamic therapy	Aminolaevulinic acid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in percent (%) of the initial area in mm2 assessed on recall appointment and by a blinded examiner on photographs with a caliper.		each treatment average once a week, recall after 4 weeks

Secondary Outcomes

Measure	Description	Time Frame
pain due to treatment, assessed by visual analogue scale (VAS)		each treatment, average once a week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Existing Leukoplakia simplex SIN III (diagnostics by Biopsie)
Leukoplakia verrucosa without indications of malignant changes (diagnostics by Biopsie)
Oral Lichen planus SIN III (diagnostics by Biopsie)
Good mouth hygiene status (tartar, surface)
Correct seat of the prosthesis and/or the denture
Located erosions in the oral cavity
Minimum age:18 years
Women at the age capable of child-bearing with an appropriate contraception

Exclusion Criteria:

Malignant changes of the mucous membrane, heavy Dysplasie SIN III, Carcinoma in situ - heavy vitamin deficiency
Pregnancy
less than 18
Satisfying women
No tobacco abuse
satisfying therapy with local immunmodulators in lichen ruber
surgical therapy of leukoplakia indicated

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gabriella Dvorak, PD, DMD, MD	Medical University Vienna	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bernhard Gottlieb University Clinic of Dentistry		Vienna		1090	Austria

Condition Browse Module

MeSH Terms

ID	Term
D007971	Leukoplakia

Ancestor Terms

ID	Term
D011230	Precancerous Conditions
D009369	Neoplasms
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C428044	5-aminolaevulinic acid-n-pentylester

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided