Photodynamic Therapy for Oral Precursor Lesions

Phase 3

Completed

• Conditions: Leukoplakia; Lichen
• Interventions: Other: Aminolaevulinic acid; Other: Methylcellulose Placebo

• Registration Number: NCT01497951
• Lead Sponsor: Medical University of Vienna

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 available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-12-09
• Study First Submitted QC: 2011-12-22
• Study First Posted: 2011-12-23
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-16
• Last Update Posted: 2017-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aminolaevulinic acid	Aminolaevulinic acid	-
Placebo	Methylcellulose Placebo	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
pain due to treatment, assessed by visual analogue scale (VAS)	each treatment, average once a week

Trial Locations

Locations (1)

Bernhard Gottlieb University Clinic of Dentistry; 🇦🇹 Vienna, Austria