Photodynamic Therapy for Oral Precursor Lesions

NCT ID: NCT01497951

Last Updated: 2017-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2017-01-31

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.

Conditions

Leukoplakia; Lichen

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Aminolaevulinic acid

Group Type: EXPERIMENTAL

Aminolaevulinic acid

Intervention Type: OTHER

Photodynamic therapy

Placebo

Group Type: PLACEBO_COMPARATOR

Methylcellulose Placebo

Intervention Type: OTHER

Methylcellulose

Interventions

Aminolaevulinic acid

Photodynamic therapy

Intervention Type: OTHER

Methylcellulose Placebo

Methylcellulose

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Dvorak Gabriella

Univ.Ass.DDr., senior staff at department of oral surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gabriella Dvorak, PD, DMD, MD

Role: STUDY_DIRECTOR

Medical University Vienna

Locations

Bernhard Gottlieb University Clinic of Dentistry

Vienna, , Austria

Countries

Austria

Other Identifiers

2010_MuSH

Identifier Type: -

Identifier Source: org_study_id