Photodynamic Therapy for Oral Precursor Lesions

NCT01497951 | Completed Phase 3

• 1 other identifier: 2010_MuSH
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• pain due to treatment, assessed by visual analogue scale (VAS)

  each treatment, average once a week

Study Arms (2)

Aminolaevulinic acid

EXPERIMENTAL

Other: Aminolaevulinic acid

Placebo

PLACEBO COMPARATOR

Other: Methylcellulose Placebo

Interventions

Aminolaevulinic acid OTHER

Photodynamic therapy

Aminolaevulinic acid

Methylcellulose Placebo OTHER

Methylcellulose

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Bernhard Gottlieb University Clinic of Dentistry

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Leukoplakia

Interventions

5-aminolaevulinic acid-n-pentylester

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Gabriella Dvorak, PD, DMD, MD

  Medical University Vienna

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ.Ass.DDr., senior staff at department of oral surgery

Study Record Dates

• First Submitted: December 9, 2011
• First Posted: December 23, 2011
• Study Start: May 1, 2011
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: May 17, 2017

Record last verified: 2017-05

Locations

AU (1)